Recently, I was informed by the State Drug Administration that the allograft bone repair material “ExFuse”, which is suitable for “cooperating with non-degradable metal internal fixation products, used for filling the gap and crevice of bone defects of the limbs and spine under low weight-bearing condition during orthopedic surgery”, has been approved for registration by the State and officially launched on the market in China on November 26, 2019. “ExFuse” has been approved for registration by the State, and on November 26, 2019, it was officially launched in China. This is the only orthopaedic implant material approved and marketed in China that combines a paste-like decalcified bone matrix (DBM) with cancellous bone components, which fills a number of gaps in bone grafting materials in China. In the future, this product will play an important role in the treatment of orthopedic diseases in China.

　　Huge market potential for bone repair materials

　　Although bone repair materials and orthopaedic consumables are the same as “orthopaedic” services, but the former is still in the state of unmet market, with huge potential.

　　Generally speaking, orthopaedic consumables are often referred to as orthopaedic implants. Orthopaedic implants are generally used to replace and support missing or damaged bones and joints, and to assist orthopaedics, immobilization, and restoration of normal bone function.

　　Orthopedic Implants

　　Mainly categorized into joint replacement implants, spinal implants, dental implants, trauma and craniomaxillofacial implants, etc. Orthopaedic consumables in the domestic market are generally subdivided into three segments: trauma, spine and joint, and the materials used in their production are mostly metals, ceramics and polymers. Among them, metal materials, thanks to their excellent load-bearing effect, currently dominate the market and will maintain this trend.

　　The statistical report released by foreign research organization EvaluateMedTech in 2018 shows that in that year, the global orthopedic implant market revenue reached 37.5 billion U.S. dollars, becoming the fourth largest segment in the global medical device industry segment after in vitro diagnostics, cardiovascular, and diagnostic imaging, and accounting for about 8.5% of the market share of the entire industry. Data from the CFDA Southern Research Institute shows that China's orthopedic implantation market reached 19 billion yuan in 2016 and continued to grow at an annual growth rate of more than 15%, and it is expected that China's orthopedic implantation market will exceed 30 billion yuan in 2019.

　　Unlike orthopedic implants such as trauma, spine and joints, bone repair materials are one kind of bone-active bio-implants, which belong to the bio-regenerative materials industry. Data show that the biological regenerative materials belong to the third class of medical devices, medical devices industry segments, products are mainly used for the treatment, repair and replacement of human tissues, organs or to enhance their function, which is the contemporary science and technology involves the widest range of disciplines in one of the multidisciplinary cross-cutting areas, involving materials, biology and medicine and other related disciplines, is the two pillars of modern medicine, biotechnology and biomedical engineering. It is the important foundation of biotechnology and biomedical engineering, the two pillars of modern medicine.

　　As mentioned above, bone repair materials are used in conjunction with non-degradable metal internal fixation products for filling the voids and gaps of bone defects of the limbs and spine under low weight-bearing condition during orthopedic surgery, in synergy with orthopedic consumables. Statistics show that as early as 2001, the United States bone repair materials (excluding dental implants) market total sales of 1.5 billion U.S. dollars in 2003, this figure grew to 2.4 billion U.S. dollars, mainly used in orthopedics and spine treatment. These figures show that bone repair materials in developed countries have long developed into a multi-billion dollar industry.

　　In recent years, with the deepening of China's aging, the incidence of elderly bone diseases such as osteoporosis, herniated intervertebral discs, femoral neck fracture, etc. has also continued to rise, the domestic orthopedic implant market developed at a high speed from 2010 to 2017, with a compounded growth rate of about 15%, and has become the world's second-largest orthopedic implant market, and it is expected that in the next ten years, orthopedic implants will still have great potential for development in China.

　　However, the development of bone repair materials in China is limited due to technical barriers. Domestic listed bio-medical device enterprises represented by Zhenghai Bio have annual sales of less than one hundred million yuan of bio-osteoprosthetic materials. Some time ago, another A-share listed medical device company submitted to the State Food and Drug Administration (SFDA) for registration of biological bone repair materials because of the violation of relevant provisions of the clinical trial, was approved by the SFDA as “not registered”.

　　According to the statistics of China Surgical Yearbook

　　According to the statistics of China Surgical Yearbook, there are 20 million cases of orthopedic trauma in China every year, of which 79.35% require surgical treatment. Relevant data also shows that more than 1 million patients in China need to implant bone repair materials every year, and the future market size is close to 100 billion yuan. It can be seen that the domestic market demand for bone repair materials is far from being satisfied, and the market has great potential for development.

　　Increasing market demand for medium and high-end biomedical materials

　　Into the third quarter of 2019, with Anhui Province to determine the orthopedic implantation (spine) class of high-value consumables into the first batch of band purchasing scope, and manufacturers to carry out the “volume for price” negotiations, a similar drug 4 + 7 consumables band purchasing began to be carried out one after another in a number of provinces, and wherever you go, the product is not price cuts to match.

　　At the end of September this year, Jiangsu Province, the second round of high-value consumables volume purchasing, including ophthalmic IOLs, vascular intervention balloon class and orthopedic artificial hip joints, including three types of products into the scope of negotiations. In this situation, although orthopedic consumables are famous for “expensive”, but without the temptation of more than enough profit, the market rely on orthopedic implantable high-value consumables “gold” of the agent team will slowly reduce the inflated price of the relevant products will also tend to be rational. With the carrying out of band purchasing, it is inevitable for agents to downsize or update their products in order to find new profit growth points. The unsatisfied bio-regenerative materials industry is also waiting for the market to dig.

　　Bone Repair Materials

　　As a kind of bio-regenerative material, it belongs to the middle-end and high-end medical devices, with a wider scope of application than orthopedic high-value consumables in the clinic, including orthopedic traumatology, spine surgery, joint surgery, bone oncology, and foot and ankle surgery, as well as ophthalmology, orthopedic surgery, stomatology, pentacarpal surgery, brain surgery, and tissue engineering.

　　At the policy level, the state strongly supports the development of bio-regenerative materials. Most notably, “tissue repair and regenerative materials” has been listed as one of the five areas that China's medical device industry will focus on during the 13th Five-Year Plan period.In July 2016, the State Council issued the 13th Five-Year Plan for National Science and Technology Innovation. In July 2016, the State Council issued the “National Science and Technology Innovation Plan” (Guofa [2016] No. 43), for biomedical materials, “should focus on the layout of tissue-inducing biomedical materials, tissue engineering products, a new generation of implantation of interventional medical devices, artificial organs and other major strategic products, to improve the standard of medical grade basic raw materials, build a new generation of biomedical materials product innovation chain, improve the quality of biomedical materials products, and enhance the quality of medical devices. materials, build a new generation of biomedical materials product innovation chain, and enhance the competitiveness of biomedical materials industry”.

　　At this stage, China's biological regenerative materials are still in the initial stage of development, compared with the advanced level of foreign countries, there is still a large gap between the global biomedical materials manufacturers are mainly concentrated in the United States, Europe, Japan, South Korea and China and other countries and regions. Compared with foreign large-scale medical device manufacturers, Chinese enterprises generally have problems such as smaller scale, insufficient investment in R&D, weak original ability, insufficient market promotion and technical service ability.

　　Therefore, at present, the market supply of medium and high-end biomedical materials, especially the biological regenerative materials with tissue regeneration and trauma repair, is relatively small, and the products mainly come from a few enterprises with R&D and technical advantages. With the rapid development of China's biological regenerative materials industry as a whole, as well as downstream hospitals, patients and other biological regenerative materials to gradually improve the degree of awareness of the market demand is increasing, the production enterprises are increasingly focusing on enhancing the original technology research and development capabilities, original product production capacity, as well as the ability to cultivate new product channels, and actively research and development and production of new products and to strengthen the marketing efforts, and to further meet the clinical demand for biological regenerative materials.

　　Medical Beauty Leader Formally Enters China's Orthopedic Treatment Field

　　Recently, the approved allogeneic bone repair material “ExFuse” is a bone grafting product of Korea's Hansei Biotech Co.

　　According to public information, Han Shi Shengke was founded in 1993, located in Seoul, South Korea, is so far the only listed company in South Korea plastic surgery industry production enterprises. The company started from the plastic material, the early 90's began research and development and production of human bone extracted from high calcium collagen and human skin dressings, due to the research field is too cutting-edge, there was no relevant regulatory laws in South Korea at that time, so according to the R & D standards of Hans Biochemistry, the establishment of relevant laws and regulations to regulate the industry, known as the “Hans Law” in South Korea. “The HANS BioScience Law established its leading position in the industry. HSC entered China in 2002 and was the only Korean company allowed to import and use cosmetic materials in China, and quickly became the leader in the medical aesthetic materials industry. 2013, HSC developed ExFus Bone, which was the first product in Asia to obtain FDA 510(K) certification.

　　ExFus is precisely composed of human decalcified bone matrix (DBM), cancellous bone and carboxymethyl cellulose (CMC). Indications include comminuted fractures, spinal and joint fusion, osteogenesis imperfecta, delayed bone fusion and various bone defects. ExFuse has good biological properties, osteoinductivity and osteoconductivity, is biodegradable, promotes the formation of new bone and mineralization of bone tissue, accelerates bone healing, and can be used alone or in combination with autologous bone, other biomaterials, and growth factors to effectively repair bone injuries, making it a more ideal bone grafting material.

　　The approval of ExFuse in China marks the formal entry of Hans Biocare into the orthopedic treatment field in China, providing a new option for Chinese orthopedic surgeons and patients with bone diseases.

　　According to Jin Dezhong, General Manager of Hance Biotech China, existing bone filler materials are generally characterized by many shortcomings such as insufficient source, insufficient support strength, and poor osteoinductive properties. The ideal conditions for bone graft material are good osteoinductivity and osteoconductivity.

　　In comparison, domestic allograft bone and chemically synthesized bone generally do not contain DBM, have weak osteoinductive ability, and are mostly solid and non-plasticizable.ExFuse reasonably matches decalcified bone matrix with cancellous bone, which is enriched with active bone morphogenetic proteins (BPPs) and decalcified bone matrix (DBM), which can well promote osteoblasts growth, and the three-dimensional mesh structure of cancellous bone provides the necessary The three-dimensional mesh structure of cancellous bone provides the necessary space for bone growth. In addition, ExFuse is easy for doctors to handle, and is packaged in a syringe form that can be shaped arbitrarily. Only bone tissue that meets the standards of AATB (American Association of Tissue Banks) is used to ensure the absolute safety of the product. The carrier is carboxymethyl cellulose (CMC) which can be naturally degraded, has very low immunogenicity and no toxic side effects, so it has an unnegligible role in the treatment of orthopedic diseases.

　　The arrival of ExFuse, while filling many gaps in the domestic bone repair materials, will also inject new growth momentum into the domestic bone repair materials market. The future is promising for the market of bone repair materials with great potential.