I. Basic financial data
Data is rounded to see more financial data > >
Second, the dividend delivery scheme
Rmb 0.130 per share
III. Business Review and Prospect
I. Discussion and analysis of business conditions
The year 2021 is the year when China has built a well-off society in an all-round way, and it is also the first year of the 14 th Five-Year Plan. Standing at the historical intersection of the goal of "two hundred years", facing the global COVID-19 epidemic and the national joint "purchasing with quantity" environment, under the strong leadership of the board of directors, all employees of the company actively responded to the risks and challenges in operation, forged ahead, continued to reform, accelerated the research and development progress of new materials, new processes and new products, and actively expanded new pipelines to adapt to the new normal of epidemic and centralized procurement.
II. Description of the company’s main business, business model, industry and R&D during the reporting period.
(a) the main business, main products or services.
The company is a leading orthopedic medical device manufacturer in China, and its main business is the research and development, production and sales of implantable orthopedic medical devices. The main products are joint prosthesis products and spinal implant products. The company is one of the enterprises with relatively complete medical device registration certificates in the field of joint prosthesis in China, covering four major human joint prosthesis products, namely shoulder, elbow, hip and knee, and spinal implant products are a full range of product combinations of spinal internal fixation systems.
(II) Main business models
Based on the regulatory laws and regulations of the medical device industry, the national industrial policy, the industry competition pattern, the upstream and downstream development level of the industry, the market operation environment and other factors, and combined with the company’s own development strategic planning, resource factors and technical strength, the company’s business model is determined together.
1. Purchasing mode
The main procurement contents of the company include three categories: the first category is raw materials, mainly including ceramic blanks, cobalt blanks, titanium blanks, polyethylene and so on; The second category is energy power; The third category serves external processing, mainly including spraying, basic machining and sterilization. The company set up a purchasing department to take charge of the procurement of raw materials and outsourcing services, and formulated a perfect workflow to ensure the efficient operation of the business.
(1) Procurement process
The purchasing department of the company shall be responsible for making purchasing plans, preparing purchasing orders, transmitting purchasing information, signing purchasing contracts, checking raw and auxiliary materials and establishing purchasing records according to the purchasing needs of various departments.
In terms of finished products and raw materials, the company’s procurement process is mainly carried out by bidding. First, the purchasing department conducts pre-qualification and selects three or more qualified units or suppliers to invite bids. Then, the purchasing department and the person in charge of purchasing control the bidding process and select one or more successful bidders for cooperation. The procurement contract drawn up during cooperation should include the necessary clauses such as quality constraint, time constraint and liability for breach of contract. After the contract is approved by the company, sign a purchase contract and quality agreement with the supplier, and ask the supplier to issue relevant certification materials. After the goods arrive, the quality department will control the quality. For outsourcing manufacturers, the company strictly controls the quality of outsourcing products and services by establishing and strictly implementing the selection criteria of outsourcing manufacturers and regularly evaluating outsourcing manufacturers.
(2) Development and management of suppliers
① supplier access and evaluation mechanism
The selection mechanism of suppliers shall be implemented in accordance with the company’s bidding system. Suppliers must have business licenses, legal production and operation certificates, quality management system-related documents, performance and safety evaluation materials of purchased goods, self-inspection reports of enterprises or effective inspection reports issued by qualified inspection institutions. Subsequently, the purchasing department took the lead in organizing the production department, R&D department and quality department to jointly invite tenders, and the suppliers who passed the evaluation were included in the List of Qualified Suppliers, which took effect after being approved by the management of the company.
② Quality control measures for suppliers’ supply.
The company agreed on matters related to quality compensation in the contract and signed a Quality Agreement with the supplier, binding the quality responsibilities of both parties. If the product is unqualified due to the supplier’s reasons, the supplier shall compensate the buyer for the losses according to the agreement. The company conducts normalized quality communication with suppliers to find out the reasons for unqualified raw materials and ask suppliers to make improvements. After the supplier improvement is completed, the company will check the effectiveness of the improvement, and the company will terminate the cooperation relationship with the supplier who fails to improve as required. The company conducts regular on-site inspections or temporary spot checks on major suppliers, inspects the supplier’s production process, ex-factory inspection process, personnel and equipment and corresponding process records, and judges whether the supplier has quality management capabilities, thus ensuring the quality of supply.
③ Settlement mode and settlement cycle
The company checks with suppliers every month, and after checking with the system, sorts out different types of business payment documents, which are approved by department managers and company leaders and then transferred to financial personnel for review and remittance.
The company settles accounts according to the payment time agreed in the contract, and suppliers with long-term cooperation and a certain purchase amount have a certain credit line.
2. Production mode
The company mainly produces based on strategic planning, market demand and annual sales target. With the cooperation of relevant departments, the production department carries out the established production and processing tasks according to the production plan, ensuring the company’s annual supply capacity and ensuring a certain safety inventory.
The production department tracks the orders received by the sales department in real time, and makes a production plan according to the sales volume in previous years in combination with the company’s safety inventory standards. After the production plan is determined, the production department issues the production task list according to the planned progress, and then enters the specific production process. After picking materials, the production personnel gradually carry out machining, polishing, lettering, cleaning, aseptic treatment and other links, and finally complete the warehousing. The production department of the company strictly implements the system related to production safety. In addition, the company sends safety personnel to supervise and inspect its work, strictly implements rectification for violations of rules and disciplines, and strengthens on-site management and hidden danger investigation to ensure the elimination of hidden dangers and reduce safety accidents.
The company’s main production modes are as follows:
For products with many varieties and small and medium batches, the company adopts the unit production management mode. This model has the advantage of high efficiency of assembly line production, and can also adapt to the changes of product variety and quantity quickly. The unitized production management mode is mainly composed of two parts: production unit and management unit, in which the production unit takes products as the center, centralizes the layout of equipment with different functions according to the process flow, and creates hardware conditions for realizing continuous production flow; The management unit carries out a series of management optimization around the planning management, personnel management, material management, equipment management and quality management of the production unit, so as to shorten the product delivery cycle and improve the production efficiency on the premise of ensuring the product quality. Under the unitized production management mode, the equipment, personnel and materials are reasonably allocated, and the production mode of "one person and multiple processes" with the goal of "one flow" in the unit is conducive to shortening the processing time and production change time of products with many varieties and small and medium batches.
For products with few varieties and large output, the company adopts multi-product batch production mode. In this mode, most products are designed in standardized modules, and the parts are universal and standardized. Employees have a high degree of division of labor and high proficiency in single process operation; Metal die casting, precision casting, die forging, precision forging and other methods are widely used in the production of blanks, with high precision, small machining allowance and high material utilization rate; The production line mostly adopts special and efficient equipment and process equipment, and repeatedly produces one or several similar products. The production process is mechanized and the production cycle is short.
For products with individual special requirements, the company adopts customized production mode. Customized production is based on modular design and standardization of parts. According to the special needs of customers, combined with the application of new materials and flexible manufacturing, it carries out secondary development and reorganizes the product structure and manufacturing process. This model not only meets the demand of customization, but also helps to reduce development costs, improve production efficiency and shorten delivery cycle.
In addition, the company introduced automatic production equipment in some production links to further improve production efficiency. For example, the company introduced intelligent grinding and polishing automation equipment to grind and polish the femoral stem, ensuring the accuracy of repeated positioning, while the built-in service information system can monitor the feeding of the moving machinery, and the motion control technology can also optimize the performance of the machine.
In addition to the above-mentioned self-production mode, based on the existing production capacity and cost control, the company entrusts some production processes to outsourcing manufacturers with corresponding qualifications or conditions for production, mainly involving product spraying, sterilization, surgical tool processing and so on.
3. Sales model
During the reporting period, the promotion of the "two-vote system" policy has brought certain changes to the sales model of the company and enterprises in the same industry. Before the implementation of the "two-vote system" policy, most enterprises in the industry mainly used the distribution mode to realize the professional division of R&D, production and terminal sales, that is, the manufacturers of orthopedic medical devices focused on the R&D, production, filing, registration and marketing of various orthopedic implants and instruments and tools, and the professional dealers focused on cooperating with the manufacturers to complete the marketing, terminal channel construction, sales and distribution, follow-up service for end customers, and operation follow-up. After the implementation of the "two-vote system" policy, the traditional distribution model was challenged, and sales service providers began to assume the responsibilities of some traditional distributors. Medical device manufacturers, distributors/distributors and sales service providers participated in the product sales and supporting services.
The sales modes of the company’s main products include traditional distribution mode, two-vote distribution mode, distributor mode and direct sales mode. During the reporting period, the company’s sales model was mainly based on the traditional distribution model. With the implementation of the "two-vote system", in recent years, the income of the company’s two-vote distribution model and distributor model has increased year by year.
(1) the traditional distribution model
During the reporting period, the traditional distribution mode was the main sales mode of the company. The main criteria for the company to select a distributor are that the distributor has the qualification for operating orthopedic products stipulated by the state, and the past financial performance and legal compliance of the distributor need to be investigated by the company’s background and field investigation. Due to the different amount of hospital operations, the company has no uniform minimum absolute sales requirements for dealers, but for dealers in some areas, the company will implement a rebate policy when their sales reach a certain target. The company makes full use of the distributor’s sales network and geographical advantages, constantly tapping potential customers, enhancing the product marketing ability and expanding the market share of products. The dealer agreement period is usually one year and is renewed every year.
Under the traditional distribution mode, products are sold to terminal hospitals through traditional distributors. Distributors undertake the responsibilities of channel development and customer maintenance, and provide follow-up service and other technical services including preoperative consultation, cargo transportation and equipment disinfection to end customers. At the same time, the marketing team of the company assists distributors to jointly complete channel development and customer maintenance by providing some technical and professional support. The business process of the company’s traditional distribution model is as follows:
Under the traditional distribution mode, the company’s payment system is assessed according to two standards: credit period and credit limit, and the payment is required according to the standard that is given priority. At present, most dealers expire the credit line first. After the credit line expires, the company stops the delivery, and the company will deliver the goods after the dealer makes the payment.
During the reporting period, the traditional distribution mode of the company was buyout sales.
(2) Two-vote distribution mode
Under the two-vote distribution mode, products are sold to terminal hospitals through two-vote distributors. Among them, the two-vote distributor only undertakes the functions of channel development and customer maintenance with the assistance of the company, while the follow-up service and other technical services are undertaken by the sales service provider. The business process of the company’s two-vote distribution model is as follows:
(3) Distributor mode
Under the distributor mode, the company’s products are sold to terminal hospitals through distributors. In this mode, the distributor does not undertake the promotion service function, while the sales service provider undertakes the follow-up service and other technical services under the two-vote distribution mode, and also carries out channel development and customer maintenance with the assistance of the company. In the process of selecting a sales service provider, the company mainly considers the local end-user resources, past service experience, historical cooperation, service personnel’s ability and other factors. The business process of company distributor mode is as follows:
(4) Direct selling mode
During the reporting period, the company’s main direct selling customer terminals were major hospitals, and the company had long-term and stable cooperative relations with major direct selling terminal hospitals. In recent years, the company’s high-end products have been listed one after another, and the company has also carried out several direct sales of customization/assembly and standard joints in Beijing and other regions. Under the direct selling mode, the channel development, customer maintenance, follow-up service and other technical services of the company’s products are mainly completed by the company’s self-built marketing team. The price of the company’s products is confirmed according to the winning bid price or the internal filing price of the hospital. The business process of the company’s direct selling mode is as follows:
For overseas markets, the company may adopt distribution mode, ODM or OEM mode for sales according to the specific situation.
In addition, in order to further introduce magnesium alloy-related orthopedic implant products and expand the market of trauma implant products, the company entered into a cooperation and distribution agreement with SynteixAsiaPTE.LTD in August 2019 to obtain the marketing, promotion and sales rights of related products in China, and agreed to purchase certain minimum purchase quantities of contract products within five years. The contract is valid until December 31, 2024, but up to now, SynteixAsiaPTE.LTD has not obtained the medical device registration certificate of related products in China, so the contract has not been formally implemented.
4. R&D mode
The company’s R&D work is managed in strict accordance with the review principles of quality standards such as ISO13485 and ISO9001/GB/T19001. The specific process is as follows:
(1) Project demonstration and establishment
Based on the market research of the company’s R&D center, marketing department and other relevant departments, the company formulates the annual product development project plan. The R&D department formulates the annual product development/improvement work plan in combination with the annual product development project plan, market demand, product characteristics and technical requirements, and assigns the design and development project leader, who further clarifies the project name, project objectives, project significance, brief feasibility analysis and project planning time.
(2) Project planning and review
Combined with the actual situation of the scheme, the project leader further comprehensively evaluates the feasibility of the project, studies and supplements the product specifications, technical scheme, implementation schedule, main key technologies, risk analysis, etc., and arranges and summarizes the scheme and sends it to the department leaders for review. According to the specific needs, the project leader sets up a project team.
(3) Design, development and control
The project leader shall control the progress of product development/improvement projects as a whole, complete product development and product design change projects according to the requirements of quality system documents, and ensure the standardization of documents, processes and operations. The units of the design and development folder should at least include design and development project initiation, planning, input, output, verification, confirmation, conversion, etc.
In this stage, the project leader prepares the design and development input list, and then organizes relevant departments and personnel to review the design and development input.
(4) Verification review and registration inspection
The project team conducts mechanical and biomechanical tests according to the test plan, and verifies the products according to the relevant national standards, industry standards or company requirements.
After the company’s internal projects have passed the verification and review, the project team will prepare the relevant technical requirements documents for medical device products to be registered according to the specific requirements of relevant regulations, prepare samples for registration inspection, and submit them to the medical testing institutions recognized by National Medical Products Administration for registration inspection in time.
(5) Clinical evaluation and research
The project team and other relevant departments of the company jointly formulate the clinical evaluation plan, and determine whether the product needs clinical trials according to the product characteristics. For the products listed in the Catalogue of Medical Devices Exempted from Clinical Trials or evaluated by clinical trials and usage data of the same kind of medical devices, the company conducts comparison tests of the same products and compiles relevant clinical evaluation materials according to the relevant requirements of the Technical Guiding Principles for Clinical Evaluation of Medical Devices; For products requiring clinical trials, cooperate with CRO (Contract Research Organization) and other companies to take the lead in completing clinical trial plans and clinical trial summary reports.
(6) Application for submission and registration
The personnel in charge of registration in the project team shall compile relevant registration materials, register products and obtain approval.
(3) the industry situation
1. The development stage, basic characteristics and main technical threshold of the industry.
A. Industry development stage
Orthopedic implant medical devices is one of the important subdivisions of medical devices. Orthopedic implanted medical devices refer to the devices and materials that can be implanted into the human body through surgery to replace and support human bones or repair bones, joints, cartilage and other tissues, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, artificial joints, etc., which belong to high-value medical consumables. Because they are implanted into the human body for a long time, they have a great impact on human life and health, and their value is usually high. According to the report on punctuation information, it is estimated that the market size of orthopedic implantable medical devices in China will be about 60.7 billion yuan in 2024, and the compound annual growth rate from 2019 to 2024 will be about 14.51%.
According to the different parts of use, orthopedic implanted medical devices can be divided into four categories: trauma, spine, joint and others. In China’s orthopedic implantable medical device market in 2019, the market segments of trauma, spine and joint accounted for 85.80% of the market; Among them, trauma is the largest market segment, accounting for 29.80%; Spine ranks second, accounting for 28.23%; Joints ranked third, accounting for 27.77%.
(1) Joint implanted medical devices
According to different parts, artificial joints can be divided into artificial hips, knees, shoulders, elbow joints and so on. Benefiting from the growing medical demand, the joint market has maintained a rapid growth. According to the punctuation information related reports, the market size of joint implanted devices in China in 2018 and 2019 is 7 billion yuan and 8.6 billion yuan respectively. It is estimated that the market size of joint implanted medical devices in China will be about 18.7 billion yuan in 2024, with an average annual compound growth rate of about 6.87% from 2019 to 2024. Due to the relatively high technical difficulty, complex production process and long service life of joint implants, the market for joint implants is mainly imported products, while domestic products account for a relatively low proportion.
(2) Spinal implants.
Benefiting from the increasing medical demand and the development of minimally invasive spine technology, the market scale of spinal implant medical devices in China is also growing gradually. According to the report on punctuation information, the market size of spine medical devices in China is 7.3 billion yuan and 8.7 billion yuan in 2018 and 2019 respectively. It is estimated that the market size of spine medical devices in China will be about 17.1 billion yuan in 2024, and the compound annual growth rate from 2019 to 2024 will be about 14.42%.
(3) Implanted medical devices for trauma.
The production technology of trauma products is mature and the market development is sufficient, which has maintained rapid growth in recent years. According to the report on punctuation information, the market size of trauma implanted devices in China was 7.7 billion yuan and 9.2 billion yuan in 2018 and 2019 respectively. It is estimated that the market size of trauma implanted medical devices in China will be about 17 billion yuan in 2024, and the compound annual growth rate from 2019 to 2024 will be about 13.15%.
(1) International medical device giants have more advantages in the market.
Although the overall gap between domestic medical device companies and international medical device giants is narrowing year by year, the problem of low overall level of medical device companies in China still needs to be solved. In the domestic and international markets, international medical giants still occupy the dominant position by virtue of strong technical strength, R&D ability, capital supply ability, brand influence and higher trust.
With the acceleration of import substitution, the market share of domestic enterprises has gradually increased. However, from the perspective of the market segmentation of orthopedic implants, the degree of localization of the joint market is still low, and at present, imported enterprises still occupy a dominant position.
(2) The industrial concentration of Class 2)III medical device enterprises has gradually increased.
Under the leadership of international medical device giants, domestic medical device companies, on the one hand, step up their technological catch-up and constantly narrow the gap with international giants, on the other hand, accept increasingly strict government supervision, while the fierce competition among companies continues to increase, and high-quality enterprises rise, making it difficult for some small and medium-sized enterprises to continue to operate and be eliminated. Generally speaking, the industry concentration of Class III medical device enterprises with high technology content is gradually increasing, and the trend of survival of the fittest, mergers and acquisitions is obvious. According to the Statistical Annual Report on Drug Supervision in National Medical Products Administration, by the end of November 2018, there were only 1,997 enterprises that could produce three types of products, which was 25.37% lower than the 2,676 enterprises at the end of 2013. With the backward small and medium-sized enterprises being gradually eliminated or merged, the concentration of China’s medical device industry will continue to rise, and the scale of enterprises will gradually expand. While broadening the product line, they will continue to consolidate and expand their own advantages.
(3) Domestic medical device companies are accelerating the process of import substitution.
Due to the lack of strict and unified standards for equipment industry and the influence of municipal/hospital bidding mode, the medical equipment industry has been in a state of low concentration. Therefore, for a long time, many medical device companies developed in specific areas by relying on their special geographical location and marketing network. However, with the improvement of domestic innovation ability and technical level, the scale of domestic medical device companies continues to expand, R&D investment continues to increase, and the quality and approval number of domestic devices have improved, which provides the possibility for domestic products to occupy more market share.
In addition, hospitals at all levels have certain pressure to control medical insurance fees, especially the basic medical insurance system for urban residents, whose fees are mostly divided by age, and the overall amount is small; In terms of reimbursement amount, the reimbursement amount for urban residents is limited. Therefore, the long-term pressure of medical insurance fee control is great, and the increase in the use of domestic devices is an inevitable trend, which also provides an opportunity for domestic companies to accelerate import substitution.
(4) The development history is short and there are few large-scale enterprises.
The development history of domestic medical high-value consumables industry is only more than 20 years. In the field of orthopedics, the domestic manufacturers of orthopedic medical devices have a certain production capacity, and their products can basically cover various types of orthopedic diseases, and they have made certain progress in the fields of joint reconstruction devices, trauma and fixation orthopedic medical devices, orthopedic surgical instruments and spinal fixation devices. However, most domestic manufacturers of orthopedic implant consumables are small in scale, and their core products and market dominance are limited.
At present, there are few manufacturers of orthopedic implant consumables in China. From the perspective of enterprise scale, China’s orthopedic industry is still in a relatively primary stage. At the same time, because there is still a gap with imported products in prosthesis materials, prosthesis shape design, accuracy of surgical positioning instruments, joint surface smoothness, and treatment of contact surface with bone, the products of domestic manufacturers mainly focus on trauma and spine products, and the share of state-owned manufacturers in the joint market is relatively low.
(5) The competition pattern is scattered, and the trend of industry integration is obvious.
Because most of the manufacturers of high-value medical consumables and orthopedic implants in China are small in scale, the industry competition pattern is relatively scattered. In recent years, major market participants have integrated through mergers and acquisitions. For example, in 2012, Johnson & Johnson acquired Synthes, a Swiss medical plastic equipment manufacturer, and later joined DePuy subsidiary to become Johnson & Johnson DepuySynthes;; Stryker acquired China Enterprise Chuangsheng Medical in 2013; Medtronic acquired Kang Hui Medical in 2012; Xerox has successively acquired American sports medicine product manufacturer ArthroCareCorp, orthopedic robot company BueBet, and the BST-CarGe cartilage repair business of Indian pharmaceutical company PiramaHeathcare. The trend of industry integration is obvious, which provides development opportunities for enterprises with considerable scale in the industry. According to the report on punctuation information, in 2019, the top five companies in China’s orthopedic implantable medical devices market were Johnson & Johnson, Medtronic, Jiemai, Stryker and Weigao Orthopedics, with market shares of 17.24%, 9.70%, 5.97%, 5.19% and 4.61% respectively, totaling 42.71%, and the industry concentration increased.
(6) The demand for high-end products is still expanding.
With the increase of national disposable income, the increase of the proportion of the elderly population, the change of medical concept and the expansion of medical insurance coverage, the demand for high-end orthopedic medical devices in China will maintain a high growth rate.
After years of market cultivation, patients’ acceptance of orthopedic implants has been continuously improved. In the future, investment and mergers and acquisitions in the field of high-end orthopedic medical devices will increase, and good market prospects and huge growth space will bring greater impetus to the development of enterprises.
C. Main technical thresholds
Medical devices are knowledge-intensive and technology-intensive industries with multidisciplinary integration, and because orthopedic medical devices are directly applied to the human body, the safety, effectiveness, accuracy and reliability of medical device products must be guaranteed, which means that medical device manufacturers must continuously improve their technical level through continuous research and statistical analysis of large-scale clinical data before they can develop products that guarantee quality and meet customer needs. New entrants to the industry often do not have this technical level, and the difficulty of entering the market is further increased.
2. Analysis of the industry position of the company and its changes.
Based on China’s huge population base and the trend of accelerating aging, China’s orthopedic market is huge and has considerable growth potential. International orthopedic giants have successively entered the China market through local mergers and acquisitions or investment in factories. The period of investment and factory building is longer than that of mergers and acquisitions. Most international orthopedic giants choose mergers and acquisitions to open the China market.
In recent years, with the support of national policies and the opportunity of domestic market expansion, domestic orthopedic medical science and technology companies have gradually developed and expanded. The main domestic listed companies in the same industry mainly include Aikang Medical, (), Weigao Orthopaedics, () and Sanyou Medical.
The company’s main products are joint implant consumables. Because the artificial joint prosthesis needs to form a permanent combination with human bone tissue and replace the original function of human body, the raw materials of artificial joint must have better compatibility with bone and advanced bone interface fixation technology, which has higher manufacturing threshold and technical difficulty. Therefore, artificial joint is an orthopedic subdivision field with high technology content, high added value and high entry threshold. Due to the limitation of domestic raw materials and technology, imported enterprises still occupy the absolute dominant position in the whole market segment.
According to the report on punctuation information, in 2017, 2018 and 2019, the market share of foreign-funded enterprises in the joint implant device market in China was 67.88%, 66.71% and 65.06% respectively. The market share of local enterprises is 32.12%, 33.29% and 34.94% respectively, and the proportion is increasing year by year. Among them, Chunli Medical occupied 8.96% of the market share of joint implanted medical devices in China in 2019, ranking second among all local enterprises and fourth among all joint prosthesis enterprises (including foreign enterprises) in China.
3. The development of new technologies, (), new formats and new models during the reporting period and the future development trend.
3D printing technology: The company has introduced a variety of 3D printing equipment with different process types, and the "research and development project of customized and personalized prosthesis series products" is also in progress.
The company’s 3D printing equipment mainly includes EBM (Electron Beam Melting) equipment, MJF (Multi-jet Melting) equipment, and powder metal 3D printing equipment. Among them, electron beam molten metal 3D printer can melt titanium alloy powder layer by layer by using electron beam in vacuum to generate dense parts, which can realize printing of porous materials. Chunli Medical has mastered the technology of using electron beam technology to produce bone trabecula and other products. Multi-jet melting 3D printer ensures the fineness of the edge of the printed object by spraying solvent and fine agent to the laid powder, and then carries out thermal radiation heating again, so that the powder is bonded according to the model interface and stacked layer by layer.
Chunli Medical has mastered the technology of using multi-jet melting 3D printer to produce guide plate, prosthesis die test and other instrument parts. In addition, Chunli Medical can use the powder-feeding metal 3D printer to coat the surface of the medical implant produced by the traditional technology with the metal powder of medical institutions. The metal powder is uniformly melted by laser irradiation, and then cooled into a solid to be combined with the metal surface, so as to realize the porous structure on the surface of the implant and promote bone growth. In recent years,
Chunli Medical is developing a product called Advanced Customization and Individualized Joint Prosthesis based on advanced technologies such as China National Bone Database and 3D Reconstruction. Compared with the existing customized joint prosthesis products, Chunli Medical can more effectively analyze and meet the specific needs of patients. In addition, in August, 2020, Chunli Medical was hired as the drafting unit of the Group Standardization Technical Committee of the 3D Printing Medical Device Professional Committee of China Medical Device Industry Association, and participated in the formulation of the group standards of 3D Printing Tantalum Metal Hip Prosthesis, 3D Printing Tantalum Metal Knee Prosthesis, 3D Printing Tantalum Metal Personalized Bone Defect Filler and 3D Printing Tantalum Metal Spinal Prosthesis, and was rated as the "Advanced Drafting Unit of the Group Standard of 3D Printing Medical Devices" by the professional committee.
New material technology: the company has carried out research and development on porous tantalum materials and magnesium materials. Compared with other prosthetic materials, porous tantalum has a unique bone-like structure, high porosity is conducive to bone growth, highly interconnected honeycomb structure provides extensive bone growth, high friction coefficient provides good initial stability of the implant, and its physical and mechanical properties are close to that of bone, so it is an ideal bone substitute material. The project "Development and Clinical Application of Porous Tantalum Bone Repair Materials and Implantable Products" declared by the company was approved by the Ministry of Science and Technology as the key project of the National Key R&D Plan "Research and Development of Biomedical Materials and Repair and Replacement of Tissues and Organs" in 2020. In the "Tantalum Technology Series Product R&D Project", the company plans to prepare porous tantalum by CVD (Chemical Vapor Deposition) and produce customized porous tantalum personalized bone defect filler. At present, it has obtained the acceptance notice of medical device registration application issued by National Medical Products Administration; In the "research and development project of dental series products", the company plans to design customized and individualized dental implant products with porous tantalum and complete the production conversion, which is currently in the design and inspection stage.
Biomedical magnesium alloy, as a representative of a new generation of biodegradable biomedical materials, has received extensive attention in recent years. At present, the listed products are mainly concentrated in foreign countries, and the indications are narrow. Compared with other medical metal materials, magnesium alloy has obvious advantages, such as good biodegradability, biological safety and biomechanical compatibility. The mechanical properties are similar to those of bone tissue, which can be degraded after being implanted in the body, avoiding the second operation to take out instruments, which is beneficial to revision surgery and reducing the economic burden and mental stress of patients. At present, the company’s "research and development of new biomedical materials series products" project is in the design stage.
To sum up, the company has made great efforts to research and develop related emerging technologies as innovative application directions, and the research and development work is progressing in an orderly manner.
(IV) Core technologies and R&D progress
1. Core technologies and their advanced features and changes during the reporting period.
The company has been focusing on the research and development, production and sales of implantable orthopedic medical devices. After years of research and development, the company has mastered a number of core technologies, including general upgrade technology and unique technology. Among them, universal upgrade technology is a technology based on universal technology or necessary technology, combined with Chinese bone characteristics, clinical needs and feedback, to optimize and upgrade product performance or technology; Unique technology is the core technology realized by the company based on R&D experience and future R&D planning through continuous research and development by relevant personnel. The core technologies mastered by the company include hip joint core technology, knee joint core technology, shoulder and elbow joint core technology, joint bone defect technology and spine core technology.
The details of the company’s main core technologies are as follows:
(1) Core technology of hip joint
The core technologies of hip joint mainly include low-friction joint interface technology, personalized biological femur technology, press-fit biological acetabulum technology and hip joint revision prosthesis filling technology.
Advanced technology of low-friction joint interface: ① Low-friction joint interface technology refers to the technology of improving the reliability and stability of ceramic parts and reducing the risk of broken ceramic parts by optimizing the processing technology of mortar cups and lining used with ceramics, thus prolonging the service life of artificial joints. ② During hip replacement, the straightness and roundness of products used with ceramic components should be strictly controlled, so as to avoid the uneven installation stress of ceramic components during clinical use and assembly, which will lead to the fragmentation of ceramic components. ③ At present, the machining tolerance of acetabular cup and polyethylene liner of most manufacturers in the market is difficult to meet the precision requirements of ceramic assembly. The machining accuracy of the straightness and roundness of the locking structure of ceramic liner and acetabular cup of our company is controlled at 0.007mm, and the machining error in the product processing process is controlled through special tooling and fixtures to ensure stability and consistency, prevent the ceramic components from being broken due to installation deformation during use, and at the same time, the more reliable locking mechanism enhances the anti-dropping ability of the prosthesis. ④ As far as ceramic materials are concerned, foreign giants and major domestic enterprises all adopt CeramTecGmbH bioceramic materials; As far as processing technology is concerned, the company is reliable in straightness and roundness, and there is no obvious gap between the company and the highest level in the industry.
Advance of personalized bio-femoral technology: ① Personalized bio-femoral technology refers to the technology of optimizing the neck length, eccentricity, proximal and distal dimensions of femoral prosthesis based on the basic data of Chinese physiology and anatomy, and cooperating with the tools corresponding to the press-fit relationship to obtain better medullary cavity matching, stability and anti-rotation performance. ② Based on the basic data of the bones around the hip joint in China collected in the "Chinese Bone Mapping Project", combined with this technology, a personalized biological femoral prosthesis suitable for the physiological anatomical structure of Chinese people is designed, which includes two neck shaft angles of 127 and 133, and each neck shaft angle is divided into two eccentric distances, with an interval of 0.5mm as a specification; There are 4 models and 100 specifications, and the size interval between adjacent specifications is small, which is highly matched with the patient’s medullary cavity. At the same time, the prosthesis has medial and lateral grooves designed based on the different load properties between the proximal bone and the prosthesis, which effectively improves the initial stability and anti-rotation performance of the prosthesis. The optimized lateral shoulder design of this kind of prosthesis can also be applied to minimally invasive surgery.
The advance of that press-fit biological acetabulum technology: ① the press-fit biological acetabulum technology refers to improve and optimizing the acetabulum design, so that the "equator" position of the acetabulum cup is stressed, the force transmission mode is optimized, and bet stability, component connection reliability, wear resistance and the like are obtained. ② The press-fit biological acetabular prosthesis designed in combination with this technology includes a acetabular cup and a acetabular lining. The outer surface of the acetabular cup is composed of a spherical cap, a hollow spherical table in the middle and a hollow spherical table at the bottom in turn, and its total height is lower than the bottom radius of the hollow spherical table at the bottom. When the prosthesis is installed, this design makes the "equator" position of the cup bear force, optimizes the transmission mode of force, and increases the initial and long-term stability of the prosthesis. The connection mode between the inner liner and the outer cup is taper press-fitting and slot locking, and the plum blossom anti-rotation design increases the connection reliability between the parts and enhances the stability between the two parts. And the service life and wear resistance of the prosthesis are improved. This technology can realize the universal matching between mortar cup and ceramic or polyethylene lining, which is convenient for clinical use.
Advanced filling technology of hip revision prosthesis: ① The filling technology of hip revision prosthesis refers to the technology of optimizing the filling design of acetabulum defect, making the shape and internal structure of the filler more suitable for the growth of cancellous bone and improving the compatibility between the filler and acetabulum. ② The prosthetic fillers for hip joint revision designed by this technology include crescent, L, round and other forms. The overall mesh structure design of the prosthesis forms a honeycomb structure with internal interconnection, and the pore size of its porous structure can reach 500 200 μ m; The diameter of porous structure of trabecular bone can reach 500 200 μ m; The porosity of trabecular bone porous structure is 50~80%, which can make cancellous bone grow into prosthesis quickly and firmly, and the elastic modulus of prosthesis is close to the physiological bone level of human body. After the implant of prosthesis filler using this technology, it conforms to the physiological stress distribution, reduces stress shielding to a greater extent and promotes bone growth; Moreover, the filler can be compatible with the total hip socket and used in combination, which is suitable for cases with acetabular defects of different degrees and meets the clinical needs of patients. (3) Influenced by technological conditions, the related parameters of acetabular reinforcement, such as aperture, wire diameter and porosity, affect the bone ingrowth effect. Compared with similar products in the current market, the company’s hip joint revision prosthesis filler meets the requirements of relevant national and industry standards, and its porous characteristics can better meet the conditions of bone growth, and its specifications and models are richer, which is conducive to meeting the needs of patients with different degrees of illness.
(2) Core technology of knee joint
The core technology of knee joint mainly includes high polishing anatomical tibial platform technology, optimized femoral condyle anterior condyle and patella pulley technology, semi-open femoral condyle intercondylar fossa technology and diversified platform pad technology.
Advanced technology of high polishing anatomical tibial platform: ① High polishing anatomical tibial platform technology refers to the technology of improving and optimizing the design of tibial platform and adopting high polishing in the internal groove of tibial platform support, which can reduce the wear between the platform pad and tibial platform support and prolong the service life of prosthesis. ② Based on the basic data of the bones around the knee joint in China collected in the "Chinese Bone Mapping Project", the anatomical tibial plateau designed with this technology has better coverage of the tibial osteotomy surface, which effectively reduces the risk of tibial plateau sinking; On the basis of the original locking mechanism, the central anti-rotation island structure is added to further reduce the fretting between the pad and the tibial tray, reduce the back wear of the pad and reduce the osteolysis; The double-wing design can not only increase the mechanical strength but also improve the anti-rotation stability of the prosthesis.
Advanced technology of optimized femoral condyle anterior condyle and patella pulley: ① The optimized femoral condyle anterior condyle and patella pulley technology means that by improving the design of femoral condyle, the femoral condyle anterior condyle of knee joint is thinned, and the left and right sides adopt arc design technology, which can reduce the friction of anterior patellar muscle ligament, reduce the pressure and wear of contact surface, and effectively avoid anterior patellar pain. ② The optimized design of patella pulley can extend, deepen and lengthen the patella pulley in the whole range of motion, which is helpful for the patella to enter the patella pulley as early as possible, and makes the patient less prone to patella dislocation, snapping and pain after operation.
Advanced technology of semi-open femoral condylar intercondylar fossa: ① semi-open femoral condylar intercondylar fossa technology refers to the technology of optimizing the design of intercondylar fossa, reducing the amount of bone cutting, achieving the purpose of bone preservation and reducing wear. ② The femoral condyle designed by this technology adopts semi-open intercondylar fossa design, which solves the problem of large intercondylar bone cutting and preserves the intercondylar bone mass to the greatest extent; At the same time, the intercondylar box structure adopts high polishing design, which can reduce the wear of the platform pad column to the greatest extent.
Advanced technology of diversified platform pad: ① By optimizing the design of knee platform pad, diversified platform pad technology can meet the needs of different patients while achieving better stability and reducing wear. ② The products designed with this technology include the platform pad without cruciate ligament and the platform pad with cruciate ligament. Among them, the platform pad without cruciate ligament is designed with aquiline nose, which effectively prevents the risk of dislocation during high flexion; A double joint surface combination is formed between the column and the cross beam, which reduces the pressure of the cross beam on the column and reduces the wear; When buckling, the contact surface between the beam and the column gradually moves down from top to bottom, and when the buckling degree is large, the beam contacts the bottom of the column; Reduce the impact force and effectively prevent the column from breaking. However, the gasket of CR-type platform pad with backward inclination of 3 degrees is suitable for patients with intact posterior cruciate ligament and bilateral collateral ligaments. CR deep disc table pad is designed with 0 back inclination angle and raised back lip of pad, which is suitable for patients with functional problems of posterior cruciate ligament and bilateral collateral ligaments.
(3) Core technology of shoulder and elbow joint
The core technology of shoulder and elbow joint mainly includes proximal humeral prosthesis design technology and distal humeral prosthesis design technology.
Advanced design technology of proximal humeral prosthesis: ① Anatomical humeral stem technology refers to the technology of improving the anti-rotation performance of prosthesis and prolonging the life of prosthesis by optimizing the shape of humeral stem of shoulder joint, the structural design and combination of osteotomy surface. ② During shoulder joint replacement, the fretting and rotation of the humeral stem can easily lead to osteolysis and the sinking of the humeral stem, which will affect the service life of the prosthesis. Combined with this technology, the design of the proximal ellipse of the shoulder joint prosthesis can effectively prevent the fretting caused by prosthesis implantation and avoid osteolysis. The disc design at the top of the prosthesis will cover the osteotomy surface after the prosthesis is implanted to prevent the prosthesis from sinking in the later stage; To some extent, it can prolong the service life of artificial joint, reduce the revision rate and relieve the pain of patients.
Advanced design technology of distal humerus prosthesis: ① Anatomical distal humerus technology refers to the technology of optimizing the shape and width of the lower humerus, reducing unnecessary bone cutting and ensuring postoperative bone integrity. ② In elbow replacement, when the humerus side is treated, the two sides of the treated humerus lower end are easy to break, which affects the stability of the prosthesis. The elbow humerus handle designed by combining this technology can effectively ensure the stability of the prosthesis after installation, and at the same time, reducing the width can adapt to more patients and improve the application range of the prosthesis.
(4) Repair technology of articular bone defect.
Joint bone defect repair technology mainly includes pelvic bone defect repair technology, knee joint bone defect repair technology and customized individualized bone defect repair technology.
Advanced pelvic bone defect repair technology: ① The pelvic bone defect repair technology is suitable for severe comminuted fracture of acetabulum, revision of acetabulum with a large number of bone defects, severe pelvic bone defects caused by pelvic tumors, etc. The pelvic prosthesis can better achieve limb preservation, and on this basis, it can realize the integration of prosthesis, bone and muscle in the state of severe pelvic bone defect. ② The acetabular prosthesis designed with this technology can be fused with acetabular bone in patients, and the acetabular prosthesis is more firmly fixed; The range of acetabular motion angle is large, which prevents acetabular prosthesis dislocation; The acetabular prosthesis can be assembled at will according to the conditions of different patients, which meets the needs of acetabular prosthesis of different patients; Can save limbs for patients and meet different osteotomy positions in hip and acetabular surgery, the acetabular prosthesis is consistent with the position and angle of the acetabulum in the original patient, and the function of the human body can be effectively and reliably reconstructed; The iliac buttress is provided with nail holes, so that the prosthesis can be firmly fixed with human bones, and the bone contact surface is of trabecular structure, which promotes human bones to grow into the pores, and further improves the firmness.
Advanced technology of knee joint bone defect repair: ① Through optimizing the product design, knee joint bone defect repair technology can restore the flexion and extension, internal and external rotation functions of knee joint under the condition of a large number of bone defects, and fully meet the activity needs of patients on the premise of limb preservation. ② The knee prosthesis designed with this technology is composed of femoral condyle, tibial plateau support, femoral marrow needle, tibial marrow needle, osteotomy section, etc. The convex articular surface of femur is in direct contact with the concave articular surface of tibia, which increases the contact surface of the joint and restores the flexion and extension and internal and external rotation functions of the knee joint. One end of the restraint is connected with the femur with a transverse shaft, and the other end of the restraint is directly inserted into the central hole of tibia to make the prosthesis achieve maximum stability. Bionic modeling is adopted to fully meet the requirements of patients’ activities on the premise of limb preservation, so that patients can recover as freely as before.
The advance of customized and individualized bone defect repair technology: ① customized and individualized bone defect repair technology can customize the joint prosthesis by using advanced digital processing technology to better meet the special needs of patients. ② The development of customized and individualized artificial joints makes up for the shortcomings in the field of artificial joints, so that patients with rare and difficult bone diseases can obtain unique personalized prostheses. Combined with this technology, the joint prosthesis designed can be customized through the reverse use of three-dimensional data, which can solve the problem that special diseases need special-shaped structures and complex structures. Taking clinical application as the cornerstone, it integrates clinical, mechanical design, materials, technology, machining and other multidisciplinary advanced technical means to achieve the purpose of mutual supplement and mutual promotion between individualized prosthesis and standard joint.
(5) Core technology of spine
The core techniques of spine mainly include posterior cervical nail plate fixation technique, omni-directional large angle screw technique and anterior cervical fixation technique.
The advance of cervical posterior screw-plate fixation technology: ① cervical posterior screw-plate fixation technology refers to that technology of optimize the structure of the fixation plate, which can not only play a supporting role, but also fuse the bones, thus avoiding the re-closing of the door after the posterior laminectomy. ② The products designed with this technology mainly include fixing plates and screws. Among them, a porous three-dimensional structure is formed on the inner side of the fixation plate opposite to the cervical vertebrae, which can induce the bone to grow in, so that the posterior cervical nail plate fixation device and the lamina are fused together, which is beneficial to the support and fusion of the lamina and solves the problem of closing the door after operation.
Advanced technology of omni-directional large-angle screw: ① omni-directional large-angle screw technology refers to the technology of improving the movable angle of screw to facilitate surgical implantation by optimizing the screw structure. ② The products designed in combination with this technology mainly include nail sleeves, fasteners, washers, locking nails, plugs, etc. Pedicle screws can obtain a unilateral swing angle of 50 degrees, which makes the implantation of connecting rods more convenient and flexible, and meets the needs of alignment of most doctors in clinical surgery and anatomical variation fixation.
Advance of anterior cervical fixation technology: ① Anterior cervical fixation technology refers to the technology of reducing the notch of anterior cervical bone plate by optimizing the structure of bone plate and locking ring, and reducing the swallowing difficulty of patients due to too high notch. ② The products designed with this technology mainly include bone plates and screws. Screw holes are formed in the bone plates, and screws can be implanted into the screw holes in the bone plates to connect the bone plates with vertebral bodies. Locking rings are embedded in the screw holes in the bone plates. After the screws are implanted into the screw holes in the bone plates, the locking rings contact with the nut positions of the screws and expand to lock the screws in the screw holes in the bone plates. The original locking nail is changed into the current screw self-locking structure, which reduces the risk of screw falling off, and adds positioning holes on the bone plate to prevent the bone plate from shifting when implanted.
During the reporting period, none of the above core technologies has changed.
2. R&D achievements obtained during the reporting period
As of December 31st, 2021, the company held 49 registration certificates and filing vouchers for producing medical devices (joint prosthesis products, spine products and sports medical products covering our four joints) in China, among which 16 were Class III medical device registration certificates, 4 were Class II medical device registration certificates and 29 were Class I medical device filing vouchers.
In terms of domestic registration, the company obtained the registration certificate of single condyle knee joint and patellofemoral joint prosthesis. In terms of international registration certificate, the company has obtained the CE certificate of expanded hip joint prosthesis, CE certificate of expanded knee joint prosthesis, EU free sales certificate of hip joint prosthesis and EU free sales certificate of knee joint prosthesis, and obtained the registration certificates of hip joint prosthesis, knee joint prosthesis and spine prosthesis in Syria, Iraq and Ecuador, the registration certificates of hip joint prosthesis and knee joint prosthesis in Turkey and the registration certificates of tumor hip joint prosthesis and tumor knee joint prosthesis in Mexico.
The company has obtained the transformation project of scientific and technological achievements in Tongzhou District, Beijing, the transformation project of tantalum modified biomedical titanium alloy materials, the industrialization project of patented technological achievements in Tongzhou District, the key support project of high-tech industry development in Tongzhou District in 2021, the registration certificate of spinal fusion cage and hip prosthesis, the key support project of high-tech industry development in Tongzhou District in 2022, the digital workshop construction project of orthopedic implants, and the research of porous tantalum artificial vertebral body in Beijing’s innovative studio project of outstanding young engineers. Company Post-Doctoral Research Center obtained the general project of China postdoctoral science fund "Study on Composite Modification of Ceramic Surface of Medical Zirconium Alloy and Its Service Performance", the project funded by Beijing postdoctoral research activities "Design of Multi-layer Membrane Structure and Study on Friction and Wear Behavior of Tantalum Modified Biomedical Titanium Alloy Surface" and the open project of State Key Laboratory "Preparation Technology and Performance Study of In-situ Oxidized Ceramic Layer on Biomedical Zirconium Alloy Surface".
A number of products developed by the company have obtained Beijing new product and new technology certificates, including 160 femoral stem (certificate number:
3. R&D investment table
Reasons for significant changes in total R&D investment compared with the previous year
Mainly because the company attaches importance to the research and development of new products, new technologies and new processes, and continues to increase the demonstration of R&D projects, the investment in R&D personnel salaries and other related expenses has increased; Based on the national joint collection situation, the company has increased the research and development of new pipelines such as joint surgery robot, sports medicine, PRP and oral cavity.
4. Research projects
5. R&D personnel
6. Other explanations
Iii. Analysis of core competitiveness during the reporting period
(A) analysis of core competitiveness
During the reporting period, the company’s core competitiveness has not changed significantly.
1. Technical barriers to product design
① Implants with appropriate size, shape and design can significantly increase the success rate of orthopedic surgery, among which the main performance of joint products is to require its wear resistance and stability of bone interface, so as to prolong the service life of products. Among them, the improvement of wear performance is realized by the selection of friction materials and the design of joint construction, and the stability of bone interface is realized by surface treatment technology and the design of handle, cup and other parts. ② As one of the earliest enterprises in China to develop and produce advanced joint prosthesis products, based on clinical needs and doctors’ suggestions, the company has continuously improved its technical level through continuous research and statistical analysis of large-scale clinical data, and mastered mature experience in product design and development, from product market research, project establishment, drawing design and parametric programming, to product finite element analysis, mechanical test, biological or zoological verification, clinical trial, product functional test, and then to registration application and trial production.
2. Technical barriers to product processing
① The production and processing of orthopedic implanted medical devices involves many processes, such as blank forming, machining, surface treatment, laser marking, cleaning, sterilization and so on, which requires high quality and safety of products. ② The company has a relatively mature and perfect processing flow, with traditional materials-reducing processing equipment such as turning, milling, planing, grinding and drilling, and materials-increasing processing equipment such as metal printers and resin printers, so as to ensure that the processed products are qualified in all aspects and accurately control every link in the production process. ③ The company has mastered some new processing technologies. The mesh structure of 3D printing products can realize rapid and firm bone growth. The company has advanced 3D printing equipment and mastered more mature printing technology, which can print biological prostheses with excellent performance. In addition, the company has initially mastered the chemical vapor deposition (CVD) process, which can realize the production of some porous tantalum metal products.
3. Technical barriers to research and development of new materials
① Biomedical degradable magnesium and magnesium alloy products: Biomedical magnesium alloy, as a representative of a new generation of biodegradable biomedical materials, has received extensive attention in recent years. At present, the company’s research based on magnesium alloy is being carried out in an orderly manner. ② Porous tantalum: Compared with other prosthetic materials, porous tantalum metal products have a unique structure similar to bone, high porosity contributes to bone growth, highly interconnected honeycomb structure provides extensive bone growth, high friction coefficient provides good initial stability of implants, and its physical and mechanical properties are close to those of bones, so it is an ideal bone substitute material; At present, the company’s research based on porous tantalum is being carried out in an orderly manner. The project "Development and Clinical Application of Porous Tantalum Bone Repair Materials and Implantable Products" led by the company was approved by the Ministry of Science and Technology as the key project of the national key R&D plan "Biomedical Materials R&D and Tissue Organ Repair and Replacement" in 2020.
(II) Events that have seriously affected the core competitiveness of the company during the reporting period, impact analysis and countermeasures.
Fourth, risk factors
(A) Not yet profitable risk
(2) Risk of sharp decline in performance or loss
(C) core competitiveness risks
Orthopedic implanted medical devices stay in the human body for a long time, which requires high safety and needs to conform to the human bone structure. On the one hand, the ideal orthopedic implant material needs to have good biological properties such as biocompatibility, bioactivity and corrosion resistance, on the other hand, it needs to have good mechanical properties such as fatigue strength, mechanical stability, friction and wear performance. In recent years, new materials such as PEEK, degradable magnesium alloy and bioceramics have also appeared in clinical applications. The company has made corresponding layout for the research and development of new materials such as porous tantalum, magnesium alloy and PEEK, but there is still a certain gap compared with foreign giants. In the process of R&D, on the one hand, the company may face risks such as deviation in its own R&D direction, lagging R&D progress, and unsatisfactory R&D results, which may lead to an increase in R&D costs and time investment or even the suspension or failure of R&D projects; On the other hand, if the company’s R&D fails to achieve the expected material results and turn them into products, or the new materials cannot be effectively industrialized due to factors such as production technology and production cost, or the new materials cannot be successfully recognized by customers and markets, the company’s early R&D investment may not bring the company income or enhance its competitive advantage as expected, thus adversely affecting the company’s ability to continue to operate.
(4) Operational risks
(A) the risk of changes in sales model
The sales modes of the company’s main products include traditional distribution mode, two-vote distribution mode, distributor mode and direct sales mode. During the reporting period, the company’s sales model was mainly traditional distribution model. With the continuous expansion of the promotion scope of policies such as "two-vote system" and "purchasing with quantity", the revenue proportion of the company’s traditional distribution model will decrease year by year in the future. If the company can’t adapt to the changes of sales model in time and enhance the transformation ability of sales model, it will face the risk of blocked sales channels and customer loss.
(B) Market competition intensifies risks
The company’s main products are implantable orthopedic medical devices, and its end customers are medical institutions. For a long time, most of the domestic market share has been occupied by international brands such as Johnson & Johnson, Medtronic and Stryker. In recent years, with the technical progress and policy support, the trend of localization substitution is obvious.
However, the market share of domestic brands is still small, and domestic brands are facing fierce competition. The company must improve its product innovation and R&D strength according to market changes and industry development trends, so as to maintain its competitive advantage and develop steadily in the rapidly changing market environment. If the company fails to accurately grasp the development trend of the industry or correctly respond to the sudden changes in market competition in the future, it will face the risk of declining market share and product prices brought about by intensified market competition.
(C) the risk of declining market demand for implantable orthopedic medical devices
In recent years, with the acceleration of social aging in China, the number of patients with orthopedic diseases has accelerated, and the market scale of implantable orthopedic medical devices has also increased. In this context, during the reporting period, the company’s sales model increased year by year and maintained a high growth rate. If the disease spectrum or treatment methods change in the future, the clinical demand for implantable orthopedic devices will decrease or the medical insurance budget will decrease, which will lead to the decline of the market model of the company’s main products, which may adversely affect the company’s operation.
(D) Risk of income growth decline or fluctuation
From 2018 to 2021, the company’s operating income increased rapidly year by year, maintaining a good upward trend. Affected by the epidemic in 2020-2021, the growth rate of the company’s operating income declined. In the future, the company may fail to effectively expand sales channels, increase market share or promote R&D projects due to changes in macroeconomic environment, repeated epidemics, intensified product market competition and poor internal management of the company. The above situation may lead to a decline in the growth rate of the company’s operating income or a certain degree of fluctuation.
In September, 2021, the state organized the Joint Procurement Office of High-value Medical Consumables to publicize the results of this national procurement with quantity, and the terminal prices of the products to be selected by Chunli Medical and other selected manufacturers all dropped significantly. It is expected that the price reduction pressure will be further transmitted to the distribution price after the implementation of the procurement with quantity in the future. If the increase in the company’s sales volume cannot make up for the decline in the distribution price, the company may experience a decline in revenue and profits.
(E) Risk of supplier dependence
From 2018 to 2021, the company’s largest supplier accounted for a relatively high proportion of the total procurement in the current period. The specific products purchased by the company from CeramTecGmbH are ceramic ball heads, ceramic linings, etc. During the reporting period, the company increased the promotion of high-end products such as ceramic joint prostheses. In view of the high stability requirements of ceramic joint prostheses, the company chose CeramTecGmbH as the qualified supplier of ceramic parts of the company, and did not purchase similar products from other suppliers, so there was some supplier dependence. If we can’t reach an agreement with CeramTecGmbH on commercial terms in the future, or because of natural disasters, international trade disputes and other force majeure factors, CeramTecGmbH can no longer provide ceramic ball heads and ceramic linings to the company, which will adversely affect the company’s production and operation.
(VI) Lease risks of production and business premises
During the reporting period, part of the real estate used by the company for production and operation was acquired through leasing. If the lease cannot be renewed normally upon expiration, the rent is greatly increased during the lease renewal, or the lessor breaches the contract during the lease process, it may have a certain adverse impact on the normal production or operating costs of the company.
(seven) the risk of core materials relying on a single overseas supplier.
During the reporting period, the ceramic ball heads and ceramic linings used in the company’s ceramic joint prosthesis products were purchased from CeramTecGmbH. CeramTecGmbH is an advanced supplier of ceramic materials headquartered in Germany. Mainstream joint manufacturers at home and abroad, including Johnson & Johnson, Xerox, Stryker, Jiemai Bangmei, Aikang Medical, Chunli Medical and Weigao Orthopaedics, all purchase ceramic materials from the company. Due to international political and other force majeure factors, the supply of imported raw materials may be delayed, limited or the price may be raised. If the company can’t get enough raw material supply in time, the normal production and operation of the company may be adversely affected. At the same time, affected by international trade disputes, there is a risk that the purchase price will increase due to the increase of tariffs.
(VIII) external processing Risk
During the reporting period, the company’s spraying, basic machining, sterilization, surface treatment and other processes were mainly produced by outsourcing. If the company fails to effectively implement the outsourcing management measures, it may bring certain risks to product quality and delivery time; At the same time, if the outsourcing manufacturers fail to provide products with good quality and quantity according to the agreement, or violate the agreement, the company’s technical and commercial secrets will be leaked, which will have an adverse impact on the company’s production and operation.
(9) Risks not included in the procurement catalogue with quantity
In May 2019, the eighth meeting of the Central Committee for Deep Reform deliberated and adopted the Reform Plan for Managing High-value Medical Consumables. In July of the same year, the General Office of the State Council issued the Reform Plan for Managing High-value Medical Consumables, proposing: "For high-value medical consumables with large clinical consumption, high purchase amount, mature clinical use and produced by many enterprises, we should explore centralized procurement according to categories, encourage medical institutions to jointly carry out quantity negotiation procurement, and actively explore cross-provincial alliance procurement. Many provinces across the country have successively carried out pilot procurement of high-value consumables. On November 20th, 2020, the National Medical Insurance Bureau’s Medical Price and Bidding Guidance Center issued the Notice on Developing the Fast Data Collection and Price Monitoring of the Second Batch of Centralized Procurement of High-value Medical Consumables. The products involved in the second batch of centralized procurement include the following categories: artificial hip joint, artificial knee joint, defibrillator, occluder, orthopedic materials and stapler.
On April 1st, 2021, the Office of Joint Procurement of High-value Medical Consumables organized by the State issued the Notice on Information Collection of Some Orthopedic High-value Medical Consumables. On the basis of collecting the purchasing data of medical institutions in the early stage, in order to further understand the market situation of orthopedic high-value medical consumables, it is planned to carry out the information collection of orthopedic high-value medical consumables in batches. The first batch of high-value medical consumables such as artificial hip joint and artificial knee joint were collected.
On June 21st, 2021, the Office of Joint Procurement of High-value Consumables organized by the State issued the Announcement of National Centralized Procurement of Artificial Joints (No.1), and on August 23rd, 2021, it officially issued the Procurement Document of National Centralized Procurement of Artificial Joints, giving a comprehensive explanation on the product categories, procurement rules and bidding rules of this centralized procurement. The company won the bid for group A of ceramic-ceramic hip joint product system, group B of ceramic-polyethylene hip joint product system and alloy-polyethylene hip joint product system, but failed to win the bid for initial total knee replacement. The company’s inventory is relatively high, and it failed to replace the artificial total knee joint product system for the first time in the national procurement bidding with quantity. If the company can’t take corresponding remedial measures, the market demand will drop rapidly, and the company’s related products will face the risk of unsalable sales that are not included in the procurement catalogue with quantity.
(ten) the spine business scale is small, and the risk of losing the bid in the procurement with quantity.
At present, many provinces in China have implemented the purchasing policy of joint products, and Anhui Province has also introduced the purchasing of spine products. In the future, more provinces may introduce the purchasing of spine products. The overall scale of the company’s spine business is small, which has a certain impact on the company’s spine products to participate in the procurement with quantity, and there are certain disadvantages in the bidding competition, so investors should pay attention to the related risks.
(eleven) the uncertainty risk in the process of import substitution.
Although the overall gap between domestic orthopedic implantable medical device companies and international orthopedic implantable medical device giants is narrowing year by year, in the domestic and international markets, international giants still occupy the dominant position with strong technical strength, research and development capabilities, capital supply capabilities, brand influence and higher trust. With the gradual advancement of import substitution trend, both sides are also in a state of coexistence of competition and cooperation. In the process of import substitution, there is a certain gap between the company and international giants in terms of business scale, product technology, production capacity and brand building, and they will face certain challenges. In the future, the company will have certain uncertain risks in the process of import substitution.
(V) Financial risks
(A) the risk of a large balance of accounts receivable
From 2018 to 2021, the company’s accounts receivable balance continued to grow. If major adverse changes occur in the operating conditions of major customers and industry settlement methods, it may lead to overdue accounts receivable, bad debts or further extension of the accounts receivable recovery cycle, thus adversely affecting the company’s sustainable profitability.
(VI) Industry risks
The company is mainly engaged in the research and development, production and sales of implantable orthopedic medical devices, and its medical device industry must be fully supervised and managed by the National Development and Reform Commission, National Health Commission, National Medical Products Administration and other competent departments. Domestic enterprises engaged in research and development, manufacturing, management and use of medical devices should follow the regulations of medical device product classification management system, medical device product registration system, medical device production enterprise filing or licensing system, medical device management enterprise filing or licensing system, medical device management quality management standard, etc. The export sales of medical device products are also affected by the relevant policies of importing countries.
In recent years, policy changes at home and abroad have also caused multiple policy risks to the company, including:
(A) "quantity procurement" brought about by the risk of product terminal price decline
In July 2019, the General Office of the State Council issued the Notice on Printing and Distributing the Reform Plan for the Management of High-value Medical Consumables, exploring "procurement with quantity" in the field of high-value medical consumables. Up to now, Anhui, Zhejiang, Jiangsu, Fujian, Shandong and other provinces have issued and implemented the policy plan of "procurement with quantity" and implemented the bidding procedures involving joint products. Except for the company’s failure to win the bid for the "quantity procurement" of hip joints in Jiangsu Province in 2019, the "quantity procurement" of other provinces and related joint products won the bid. According to the current situation of winning the bid, the winning bid price of related products has mostly decreased to a certain extent compared with the price before "purchasing with quantity", which further led to a certain degree of decline in the ex-factory price of the company in some provinces.
In June, 2021, the National Joint Procurement Office of High-value Consumables issued the Announcement of National Centralized Procurement of Artificial Joints, Announcement of National Centralized Procurement of Artificial Joints (No.1), and in August, 2021, it officially issued the Procurement Document of National Centralized Procurement of Artificial Joints, and carried out the bidding work of national procurement of initial total hip replacement and initial total knee replacement. September 2021
In June, the state organized the Joint Procurement Office of High-value Medical Consumables to publicize the results of this national procurement with quantity. According to the public information, the average price of the hip joint terminal to be selected dropped by 80%, and the average price of the knee joint terminal dropped by 84%. The company successfully won the bid for "Ceramic-Ceramic Hip Joint Product System", "Ceramic-Polyethylene Hip Joint Product System" and "Alloy-Polyethylene Hip Joint Product System" at a relatively high price, but the price was significantly lower than that before the "quantity purchase". The company’s "knee joint product system" failed to win the bid because of its high quotation. The decline in the price of hip joint terminal and the failure to win the bid for knee joint will be transmitted to dealers and companies, and the subsequent distribution price of the company will also be reduced. If the increase in sales volume cannot make up for the decline in distribution price, the company may experience a decline in revenue and profit. In addition, if the company’s distribution price is too high, squeezing the dealer’s profit will affect the dealer’s willingness to cooperate, or returning the goods due to the termination of the dealer’s business with the company and negotiation, it may have a certain impact on the company’s profitability.
(B) The risk of knee joint products failing to win the bid for national procurement with quantity.
On September 14th, 2021, the State organized the Joint Procurement Office of High-value Medical Consumables to publicize the selected results of the national procurement of artificial joints, and the company failed to win the bid in the "knee joint product system". In 2021, Beijing Bestar Biotechnology Co., Ltd. (hereinafter referred to as "Bestar") obtained the "Record Certificate for Entrusted Production of Medical Devices" issued by Beijing Drug Administration, allowing our company to produce Bestar’s knee prosthesis as the trustee. Bethesda’s knee joint prosthesis won the bid in this collective procurement, and our company obtained the power of attorney from Bethesda (No.:BSD21-09- China -01-265), which authorized our company to sell its knee joint products in People’s Republic of China (PRC). Through the cooperation with Bestar, our company reduced the decline in profitability caused by the failure of our knee joint products to win the bid.
(C) Risk of changes in domestic and foreign industrial policies
The company is a medical device manufacturer, and its domestic sales revenue is the main source of its main business income. The domestic business development is strictly supervised by National Medical Products Administration and other competent departments. In 2018, the National Health and Family Planning Commission and other six ministries and commissions jointly issued the Notice on Consolidating and Breaking the Achievements of Supplementing Medicine with Medicine and Deepening the Comprehensive Reform of Public Hospitals, further clarifying the implementation of the "two-vote system" for the purchase and sale of high-value medical consumables. With the change of the sales model brought about by the two-vote system, the company is faced with changes in operating conditions such as longer receivable payment cycle and increased sales expenses corresponding to unit sales revenue. If the company fails to formulate effective countermeasures in time according to the changes in the "two-vote system" policy, it may have an impact on the sales and operation of its products.
In addition, policies such as medical insurance reimbursement and centralized procurement have been introduced in China, and policies such as DRGs and "one-vote system" have been actively explored. In 2021, eight ministries and commissions, including the National Medical Insurance Bureau and the National Health and Wellness Commission, jointly formulated the "Pilot Program for Deepening the Reform of Medical Service Price", with the goal of exploring and forming replicable and scalable medical service price reform experience through three to five years of pilot. In addition, the company is also actively exploring foreign markets, and the development of overseas business is strictly supervised by the competent authorities of relevant countries and regions. For example, the new version of the medical device regulation MDR passed by the European Union in March 2017, at this stage, some matters in the new MDR regulations have not yet been clearly defined, and there are certain risks of policy uncertainty.
In the future, the importance attached to the medical device industry at home and abroad will be further enhanced, and relevant regulations and policies will be issued in the aspects of industry standards, bidding, centralized procurement and circulation system. If the company can’t keep up with the development of industrial policies, study the requirements of new policies in advance, do a good job in coping with the New Deal, and continue to carry out technological innovation and product upgrading, the company may face the risk of falling product market prices, which in turn will lead to a decline in gross profit margin, which will adversely affect the company’s future profitability. The company will pay close attention to the trend of centralized purchasing policy, continuously strengthen production and management, enhance the company’s product innovation ability and comprehensive strength, strengthen market promotion, consolidate existing markets, develop new markets, and strive to increase market share.
(VII) Macro-environmental risks
In the future, the company may fail to effectively expand sales channels, increase market share or promote R&D projects due to changes in macroeconomic environment, repeated epidemics and intensified competition in the product market. The above situation may lead to a decline in the growth rate of the company’s operating income or a certain degree of fluctuation.
(8) Risks related to depositary receipts
(9) Other major risks.
V. Main operations during the reporting period
The year 2021 is the year when China has built a well-off society in an all-round way, and it is also the first year of the 14 th Five-Year Plan. Standing at the historical intersection of the goal of "two hundred years", facing the global COVID-19 epidemic and the national joint "purchasing with quantity" environment, under the strong leadership of the board of directors, all employees of the company actively responded to the risks and challenges in operation, forged ahead, continued to reform, accelerated the research and development progress of new materials, new processes and new products, and actively expanded new pipelines to adapt to the new normal of epidemic and centralized procurement.
By December 31, 2021, the company achieved an operating income of 1,108,139,500 yuan in 2021, an increase of 18.18% year-on-year; The net profit attributable to shareholders of listed companies and the net profit attributable to shareholders of listed companies after deducting non-recurring gains and losses were 322,360,700 yuan and 307,693,000 yuan respectively, with year-on-year increases of 13.76% and 11.22% respectively.
The company’s main operating conditions are normal and its operating performance is stable. There have been no major changes in the company’s business model, the purchase scale and price of major raw materials, the production and sales scale and price of major products, the composition of major customers and suppliers, tax policies, etc., and there have been no other major events that may affect investors’ judgment.
VI. The Company’s Discussion and Analysis on the Company’s Future Development
(A) the company’s development strategy
Relying on the national industrial policy of encouraging domestic (or) instrument products, and relying on years of accumulated industry experience and technical advantages, the company is committed to developing and producing joint prostheses, spinal implants and other products with excellent performance, and strives to become a world-class comprehensive medical orthopedic instrument manufacturer as soon as possible.
(3) Business plan
1, the rational use of capital market financing tools to enhance the company’s financing ability.
With the help of the capital market platform, the company will broaden the channels of capital operation, enhance the visibility of enterprises, enhance the ability to resist risks, enhance competitiveness and industrial integration, and rationally use the financing tools in the capital market to enhance the company’s financing ability, which is conducive to further promoting the company’s business development and helping the company’s long-term sustainable development in the future.
2, continuous talent introduction and training, to create a compound professional talent echelon.
The company will continue to implement the people-oriented human resources strategy, introduce and effectively cultivate compound talents on the basis of the existing talent team, cultivate cross-knowledge structures in marketing and academic promotion, research and development, production and comprehensive management, and establish a marketing system with flexible organization and project management as the leading direction to meet the needs of the rapid development of the industry and the company. The company will further establish a standardized and professional training system, strengthen employee on-the-job training and follow-up education and training, fully mobilize the enthusiasm and creativity of employees, give full play to their potential, and actively cultivate their expertise to achieve sustained and healthy development with the company.
3. Improve the construction of R&D platform and effectively promote the overall layout of products.
Based on the existing R&D capabilities, the company plans to build a multi-functional R&D platform that can meet the company’s long-term R&D requirements, and improve the company’s independent R&D capabilities and new product R&D efficiency. In the future, after the R&D center project of the company is completed and put into use, the company will make full use of advanced hardware conditions, rationally use R&D funds to effectively invest in the research and development of new products, improve the R&D transformation ability, further enrich and optimize the company’s product pipeline, and better provide orthopedic implanted medical devices with high quality and strong applicability for patients with orthopedic diseases.
4. Improve the construction of marketing network.
In the future, the company will further improve its marketing network, meet the growing demand of the downstream market and consolidate and expand its market share in combination with the expansion of its production capacity.
After the completion of the new marketing network project, the coverage and radiation level of the company’s marketing network will be further strengthened. The construction of marketing training center will provide systematic support for the clinical promotion and doctor training of the company’s products, and promote the brand promotion of the company in an all-round way and enhance the brand image of the company. The rapid expansion of marketing and distribution outlets will help the company quickly respond to the needs of terminal medical institutions and provide matching products for personalized orthopedic surgery in time. The marketing network information system, the newspaper station system and the customer management system will further strengthen the company’s management ability to customers, distributors and terminal hospitals and improve the level of information management.