On October 8, 2022, Yantai Zhenghai Biotechnology Co., Ltd. active biological bone product was successfully approved for marketing by NMPA (NMPA), marking the success of an epoch-making innovative medical device product designed and developed by the Institute of Genetic Development, Chinese Academy of Sciences Dai Jianwu Regenerative Medicine Innovation Team after 20 years.
Researcher Dai Jianwu received funding from the 00 people program of the Chinese Academy of Sciences in 2001 to establish a regenerative medicine laboratory at the Institute of Genetic Development, Chinese Academy of Sciences. The scientific goal of the laboratory is to develop active biological materials and products based on collagen biological materials and tissue regeneration factors that can directively induce tissue and organ regeneration. At the beginning of its establishment, active biological bone and spinal cord nerve regeneration scaffolds were used as the main core topics of the laboratory. The initial goal of the team to design active biological bones is to solve the side effects caused by excessive amounts of osteogenic growth factor (BMP2) in Medtronic active bones. Researcher Dai Jianwu believes that the biggest problem with Medtronic's products and later Stacy's active bone products is that the diffusion of osteogenic growth factors causes excessive use and obvious side effects. To solve this problem, the team designed the collagen binding region obtained from collagenase , fused with BMP2 to express it, obtain BMP2 that can specifically bind to collagen material, named CBD-BMP2, and specially designed collagen-containing bone material, which combines CBD-BMP2 with collagen-containing bone material to form active biological bone. Dr. Chen Bing, a in the research team, published a series of articles as the first author, proving that this original design can greatly reduce the amount of BMP2 used in active biological bones and achieve better osteogenic activity. As one of the first batch of graduate students recruited by Dai Jianwu's laboratory, Dr. Chen Bing is now an associate researcher at the Institute of Genetic Development, Chinese Academy of Sciences.
Figure Active biological bones have super ectopic induced osteogenesis activity
above reference:
1.Chen, B., Lin, H., Wang, J., Zhao, Y., Wang, B., Zhao, W., Sun, W., Dai, J.* Homogeneous osteogenesis and bone regeneration by demineralized bone matrix loading with collagen-targeting bone morphogenetic protein-2. Biomaterials. 28(6):1027-35. 2007
2.Chen, B., Lin, H., Zhao, Y., Wang, B., Zhao, Y., Liu, Y., Liu, Z., Dai, J.* Activation of demineralized bone matrix by generally engineered human bone morphogenetic protein-2 with a collagen binding domain derived from von Willebrand factor propolypeptide. J Biomed Mater Res A. 80(2):428-34. 2007
3.Zhao, Y., Chen, B., Lin, H., Sun, W., Zhao, W., Zhang, J., Dai, J.* The bone-derived collagen containing minerized matrix for the loading of collagen-binding bone morphogenetic protein-2. J Biomed Mater Res A. 88(3):725-34. 2009
Another key technical problem in the development of active biological bone is the problem of BMP2 solubility. The osteogenic growth factor BMP2 used in Medtronic active bone materials can only be dissolved and stored in acidic solutions, and acidic solutions can easily cause calcium loss, which is not conducive to bone regeneration. Through nearly 10 years of efforts, the protein purification team led by Hou Xianglin and Chen Bing of Dai Jianwu's team have established the original protein regeneration and purification preparation process. The BMP2 prepared can be dissolved in neutral solution, which makes large-scale production of BMP2 possible. In 2011, Dai Jianwu's team completed the standardization research on CBD-BMP2.
Figure CBD-BMP2
In 2015, Yantai Zhenghai Biotechnology Company purchased the exclusive use rights of the intellectual property of active biological bone from the Institute of Genetic Development, Chinese Academy of Sciences, and organized multi-center clinical trials of the product. I started applying for product registration with NMPA in 2018. Since this product is a truly original product with a breakthrough of 0 to 1, after a long process of replenishment, I finally obtained approval for registration and launch on October 8, 2022. The approval of this active biological bone product marks a new era of innovation and review of medical devices in my country. As the uncrowned king of today's medicinal devices, active biological bone will surpass similar products from scientific foundation to clinical application, marking that China's medical device scientific research and innovation has reached an international leading position.
