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Great news! DiQi Pharma’s First Biodegradable Material PLGA (8515) Successfully Registered with CDE
Release time: 2020/03/30

DiQi Pharmaceuticals Co., Ltd.'s first biodegradable material, L-lactide-L-glycolide copolymer (8515) (for injection), was successfully registered with the CDE on March 27, 2020, marking the first domestic registration of this product. DiQi Pharmaceuticals Co., Ltd promptly submitted a registration application for L-lactide-L-glycolide copolymer (7525) (for injection) and plans to submit another application for L-lactide-L-glycolide copolymer (5050) (for injection) this year.

Poly-(d,l-lactic-co-glycolic acid), abbreviated as PLGA, is a polymer composed of glycolic acid and lactic acid units. Based on the ratio of lactic acid to glycolic acid units in its molecular chain, it can be further classified into different grades such as 85/15, 75/25, and 50/50. Due to their similar physicochemical and biological properties, different PLGA grades can be considered as belonging to the same class of substances. Poly(lactic-co-glycolic acid) has been included in the Chinese Pharmacopoeia and the U.S. FDA's Unique Ingredient Identification Number (UNII) system, primarily serving as a drug carrier for sustained-release formulations. This excipient is also listed in the Handbook of Pharmaceutical Excipients and included in the GRAS (Generally Recognized as Safe) list under the categories of bioabsorbable, biocompatible, and biodegradable substances. It is primarily used in various implantable and injectable drug delivery systems for human and veterinary applications.

DiQi Pharmaceuticals Co., Ltd possesses the technology to prepare PLGA and PLA with different terminal groups, molecular weights, and monomer ratios, meeting the needs for developing various long-acting drug delivery formulations.

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