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Dikang Pharmaceutical Obtained Invention Patent Authorization and Master File Registration for Decellularized Matrix Raw Material

Author: 奥泰康 Time:2024.09.18

On September 6, 2024, the National Intellectual Property Administration approved a new invention patent for Beijing Dikang Pharmaceutical Investment Management Co., Ltd.'s decellularized extracellular matrix(d-ECM), with the patent titled "Preparation Method of Decellularized Bioretinal Membrane and Decellularized Bioretinal Membrane Produced Therefrom" (Patent No.: ZL 2024 1 0815430.2).





Raw Material Has Passed Master File Registration


Previously, in the latest "Master File Registration Information Disclosure" published by National Medical Products Administration's Center for Medical Device Evaluation, Dikang Pharma's decellularized extracellular matrix biomaterial had also passed master file registration. The raw material is based on the research and development achievements of the National 13th Five-Yea Key Research and Development Plan of China, "Engineering preparation technology and product development of low immunogenicity collagen and silk fibroin" (SQ2017YFSF100202). The passage of master file registration marks an important milestone and it provides a legally sourced raw material for the research and development and manufacturing of decellularized extracellular matrix-related products in the medical industry.

 

Decellularized Extracellular Matrix

Decellularized extracellular matrix (dECM) is a natural material purified by removing cells, antigens and other components from animal or human tissues using different decellularisation techniques such as physical, chemical and biological.And it has the main components of extracellular matrix(ECM). Extracellular matrix (ECM) is the microenvironment for cell survival, and together with cells, it forms human tissues and organs, and its complex three-dimensional network structure consisting of numerous proteins and polysaccharides provides stable signal transmission and structural support for tissues and organs. Because of its ability to play a better repair and regeneration efficacy, decellularized extracellular matrix is considered to be a new generation of biomaterials suitable for regenerative medicine, which plays an increasingly important role in the fields of tissue repair, organ transplantation and regenerative medicine, and has great potential for development.





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