In millions of years, we have evolved from ape man to Homo sapiens and then to modern humans, which is inseparable from the upgrading and evolution of human tools. From containers made of clay to smelted steel, from Jenny engines to steam engines, the continuous innovation of materials has become an important symbol of the progress of human civilization and an essential element for the development of science and technology.
In the field of medicine, one of the important milestones in the development of the medical industry is the breakthrough of biomedical materials, from the first generation of bioinert materials such as bone nails and bone plates to the third generation of biomaterials with induced regeneration properties, every breakthrough in biomedical materials has brought great changes to the industry, giving birth to new medical devices, and giving new life to traditional medical devices.
According to data released by Markets And Markets, a global market research organization, the global biomaterials market size was $105.18 billion in 2019 and is expected to grow to $206.64 billion in 2024. Focusing on the third generation of regenerative biomaterials, according to Statista, the global regenerative medicine market size was about $16.9 billion in 2021 and is expected to reach $65 billion in 2028.
As one of the frontier medical fields of interdisciplinary application of science and technology, regenerative medicine has always been a key support area for biotechnology research and development in mainland China. From the "Eleventh Five-Year Plan" period, the mainland proposed to establish a preclinical evaluation system for reproductive and regenerative medicine, to the "13th Five-Year Plan" issued by the National Development and Reform Commission and other departments in the "13th Five-Year Plan" National Strategic Emerging Industries Development Plan, which included cell tissue-inducible biomaterials in the "Guiding Catalogue of Key Products and Services for Strategic Emerging Industries", and then to the "14th Five-Year Plan" key research and development plan to include natural biomaterials such as chitosan, silk fibroin, cell matrix, etc. in the "diagnosis and treatment equipment and biomedical materials" Regenerative medicine has become the frontier direction of the country's key layout and planning.
On the whole, the development of recycled biomaterials is in full swing and it is a well-deserved sunrise industry. Among them, in addition to the painstaking research of countless scientific researchers, CDMO of medical devices is also indispensable to add a fire to it. On October 27, 2023, the Beijing CDMO Center of Aotaikang Group, a well-known CRO &CDMO company founded in 2006, completed the relocation to further expand the scale of its R&D and production workshop, improve the capacity and efficiency of biomedical materials R&D and production, and truly promote biomedical materials to a higher level.
As one of the first batch of medical device CRO companies in China, Aotaikang is also a "pioneer" in the field of medical device CDMO.
Undertake the "13th Five-Year Plan" national key R&D projects, and lay out two major biomedical materials R&D and transformation platforms
Born in 2006, Aotaikang has witnessed the rise and maturity of China's medical device market, and also promoted the development of China's medical device market and China's CRO industry. While achieving a leading edge in the field of medical devices, it also lays out the field of biomedical materials through in-depth incubation, from indirect participation in the incubation of innovative medical device enterprises through CRO services, to the mode of providing a full set of clinical registration technology solutions, funds and personnel to directly participate in the incubation of innovative medical device enterprises, and continuously improves the depth of incubation.
Based on the company's deep cultivation in the field of biomedical materials in the past ten years, Aotaikang undertook the "13th Five-Year Plan" national key R&D project - "engineering preparation technology and product research and development of low immunogenicity collagen and silk fibroin", set up Aotaikang CDMO center, and provided technology upgrading and new project reserve services for production-oriented and sales-oriented enterprises, and has established strategic partnerships with many domestic and foreign pharmaceutical and medical device companies such as Fosun Pharma, Shuanglu Pharmaceutical, and Xinyang Group.
According to relevant media reports, during the "Eleventh Five-Year Plan" period, the mainland invested a total of 400 million yuan in biomedical materials research. During the "Twelfth Five-Year Plan" period, the figure increased to 510 million yuan, and at the same time, the research and development of advanced medical equipment and biomedical materials was included in the national medium and long-term science and technology development plan. From the increasing capital investment year by year to the inclusion in major plans, all of them reflect the mainland's determination to conquer biomedical materials and seize the initiative.
From a global point of view, the biomedical materials market is highly monopolized by developed countries. Johnson & Johnson, Medtronic, Zimmer Bonmei, Stryker and other top 30 companies with market share occupy more than 70% of the global biomedical materials market.
At the 2014 International Forum on New Materials and Industrialization, Xi Tingfei, chairman of the Federation of Asian Biomaterials Societies, also pointed out several major challenges in the development of biomedical materials in the mainland, including product structure, lack of independent innovation and raw materials, and clinical transformation. ”
In other words, at that time, there were very few companies that could undertake the "13th Five-Year Plan" national key R&D projects. In addition to the R&D experience accumulated over the years, the reason why Otaikang was able to undertake this project is inseparable from the strong strength of its core team. Aotaikang founder and executive director Rao Yiwei as the project sub-project leader, he has nearly 20 years of industry experience, Aotaikang Beijing CDMO Center has applied for more than 10 patents, and authorized 5, its chief scientist Professor Wang Haibin of Beijing Jiaotong University, as a research expert in biomaterials and regenerative medicine, has undertaken 7 "Twelfth Five-Year" science and technology projects, has won the second prize of the Military Science and Technology Progress Award, and has been selected into the first batch of Beijing Jiaotong University "Youth Talent Cultivation Program" Class I. Aotaikang Suzhou CDMO Center has applied for more than 10 invention patents, and authorized 5, its chief scientist Professor Li Mingzhong of Soochow University, as a young and middle-aged academic leader of Jiangsu Qinglan Project, has served as the leader of the "13th Five-Year Plan" project, has presided over the completion of the National 863 Program, the National 973 Program sub-project, served as the executive director of Jiangsu Biotechnology Association, and has won the second prize of Suzhou Science and Technology Progress Award. In addition, Professor Lu Shenzhou of Soochow University, the technical consultant of Suzhou CDMO Center, has presided over national, provincial and ministerial scientific research projects for many times, and has won the second prize of Science and Technology Progress Award of China National Textile and Apparel Council, and has won the 10th Jiangsu Textile Technology Innovation Award.
Under the leadership of the strong core team, this national key R&D project undertaken by Aotaikang not only broke through the national key engineering technology, but also came with good news in May last year - the first Class III medical device registration certificate approved by the State Food and Drug Administration (National Device Note 20233140615) was obtained from the domestic device CDMO platform.
Major milestone: the first Class III registration certificate for a domestic device CDMO platform
On May 9, 2023, Aotaikang Beijing CDMO Center obtained the first Class III medical device registration certificate approved by the State Food and Drug Administration (National Machinery Approval 20233140615), which is the first Class III collagen patch dressing prepared from collagen derived from extracellular matrix as raw materials in China, and the first Class III medical device registration certificate in China that was born from the entrusted research and development of the device CRO/CDMO industry.
It should be emphasized that this project is based on the "13th Five-Year Plan" National Key R&D Program project, after the State Food and Drug Administration issued the "Notice of the State Food and Drug Administration on Expanding the Pilot Work of the Medical Device Registrant System" issued by the State Food and Drug Administration on August 1, 2019, Aotaikang Beijing CDMO Center and Hubei Heng'an Fulin Pharmaceutical Co., Ltd. completed the tissue repair project covering the whole process of market access business through strategic cooperation. Recalling the experience from the start of R&D in 2019 to the certification in 2023, Rao Yiwei, the founder of Aotaikang, said with emotion, "In the context of the new crown pandemic, the whole team worked together with researchers to accept challenges, overcome various difficulties, successfully completed clinical trials and obtained the registration certificate of Class III medical devices, which is an important milestone. ”
After signing the agreement with Hengan Fulin in 2019, it only took more than three years for Aotaikang to complete the whole process of services from research and development, production system establishment, sample production and testing, to animal experiments, clinical trials and product registration. One point that cannot be ignored is that in the process of research and development of innovative products, "based on the existing R&D reserves, through in-depth preliminary research, we strive to tailor the most suitable indication products for our cooperative customer Heng Amphrin, and at the same time enrich the customer's product line, we also cooperate with academic promotion, so that the only collagen patch dressing derived from extracellular matrix in China can help increase the market share of customers." Rao Yiwei, the founder of Aotaikang, said.
Aotaikang CDMO service process Courtesy of Aotaikang
While helping customers to complete the development of innovative products, Aotaikang has gained a lot: it has not only broken through the technical bottleneck of the industrialization of animal-derived medical materials, developed a new process of defatting and decellularization, but also applied for 4 authorized invention patents and completed 1 key R&D project of the "13th Five-Year Plan", laying a deep academic foundation and a solid intellectual property "moat" for the project.
Based on the milestone breakthrough of the project, on August 9, 2023, the Beijing CDMO Center successfully obtained the Class III medical device production license for wound dressings (Beijing Drug Administration Device Production License No. 20230053) issued by the Beijing Municipal Drug Administration, which is the first Class III medical device production license of Beijing Aotaikang CDMO Center, marking that the Beijing CDMO Center has met the regulatory requirements for the industrial production of medical devices, has the conditions for medical device production and can be officially put into production.
Two domestic first, world-leading technologies, with a cumulative R&D, production and service contract of more than 1 billion yuan
When we look back at these "first" milestones, it is not difficult to find that Aotaikang's R&D reserves have reached a "jaw-dropping" level.
At present, Aotaikang has Beijing CDMO Center and Suzhou CDMO Center, and the source of the first Class III registration certificate for the domestic device CDMO platform is Aotaikang's first domestic and one of the world's leading R&D reserves - extracellular matrix, which is responsible for the Beijing CDMO Center. Extracellular matrix is a kind of natural material that has the ability to induce tissue repair and regeneration, which is secreted by cells, provides mechanical support and physical strength for tissues and organs, and has an impact on cell adhesion, migration, proliferation and differentiation and embryogenesis, etc., with strong effectiveness and high safety technical advantages.
Extracellular matrix can be used in the repair of various tissues and organs, various surgical patches, excellent tissue filling materials, and can also assist cell therapy to improve the efficiency of cell therapy, which has broad application prospects. In addition to the decellularization technology that retains the active ingredients of the natural extracellular matrix, A-Gal antigen removal technology, cross-linking technology of extracellular matrix materials and freeze-drying molding technology are used. According to reports, at present, the technology platform has more than 30 reserve projects, 6 products have entered the clinical stage, 4 achievements have been transferred, and 3 product registration certificates have been obtained.
Silk fibroin is another domestic initiative and the world's leading R&D reserve of Aotaikang, which is responsible for the Suzhou CDMO Center of Aotaikang. This is a natural polymer fibrin extracted from silk, the content accounts for about 70% ~ 80% of silk, contains 18 kinds of amino acids, including 8 kinds of essential amino acids, glycine (Gly), alanine (Ala) and serine (Ser) account for more than 80% of the total composition. Silk fibroin has the technical advantages of high safety (good biocompatibility), strong effectiveness (biological activity) and biodegradation and control, and can be used in artificial skin and organs, sutures and drug carriers. According to reports, the technology platform has more than 20 reserve projects, 5 products have entered the clinical stage, 4 achievements have been transferred, and 3 product registration certificates have been obtained.
Whether it is extracellular matrix or silk fibroin, it is the patented technology of passive device biomaterials with independent intellectual property rights innovated and developed by the CDMO platform of Otaikang. In addition, the CDMO platform of Aotaikang, which is deeply cultivated in this field, has also reserved more than 80 new generation of mainstream medical material research and development technologies such as collagen, PLA, PLLA, dextran, PCL, peptides, polyethylene, PVA, polyurethane, polytetrafluoroethylene, microcrystalline calcium, hyaluronic acid, chitosan, hydroxyapatite, etc.
Overall, since the establishment of the CDMO platform in 2014, with the help of its rich R&D reserves and the whole process service from research and development to clinical trials, and then from registration declaration to commissioned production, its achievements can be said to be quite amazing: in the past 5 years, while obtaining 6 medical device registration certificates, it has completed more than 30 patent applications, of which 8 invention patents have been authorized, establishing a solid patent "moat"; In the past three years, more than 10 project cooperation has been completed, with a cumulative R&D and production service contract amount of more than 1 billion yuan.
Although the current mainland biomedical materials are still in a state of possible "neck", we can look forward to the situation that under the strong support of national policies, the strengthening of research and development by domestic enterprises, and the continuous breakthrough of core technologies, the CDMO of medical devices such as Aotaikang will serve as a "booster" in the field to continuously promote the transformation of the mainland biomedical materials industry and gradually realize domestic substitution.