Recently, the State Food and Drug Administration approved the listing of Shanxi Jinbo Biomedicine Co., Ltd. "recombinant type III humanized collagen freeze-dried fiber". This product is used for facial dermal tissue filling to correct forehead dynamic wrinkles (including brow lines, forehead lines and crow's feet). It is the first independently developed medical device made of a new type of biological material-recombinant humanized collagen. It has laid a good foundation for the clinical application and industrial transformation of related materials.
It is understood that collagen is the main structural protein of human tissues and organs, accounting for about 30-40% of the total body protein. At present, collagen products on the domestic and foreign markets are mainly derived from animal tissues, and are widely used clinically in skin, bone, cartilage, cardiovascular system, oral and luminal tissue repair, and medical cosmetic plastic surgery.
The recombinant type III humanized collagen used in the products approved for marketing this time has the following characteristics: First, the repeating unit of its amino acid sequence is the same as the specific functional region of human collagen amino acid sequence, and has good biocompatibility; second, its functional region has 164.88° flexible triple helix structure, the relevant structure data has been included in the international protein structure database; third, it has higher cell adhesion than human type I and type III collagen, forming a reticular fiber structure, and has good repair properties It is expected to have broader clinical applications in the fields of vascular endothelium, endometrium, wounds, oral mucosal repair and orthopedics.
The State Food and Drug Administration attaches great importance to the research and development, transformation and other related work in the field of new biological materials, and actively carries out basic work such as related standards, naming and classification, and has successively formulated and issued the "Guiding Principles for Naming Recombinant Collagen Biomaterials" and "Recombinant Collagen Medical Products" Classification and Definition Principles, etc., continuously improve the standard system in the field of new biological materials, and vigorously promote the innovation and development of the industry.
At the same time, the drug regulatory authority will strengthen the post-market supervision of related products to protect the safety of patients' equipment.
Source: Chemical Network
