Shanghai Fosun Pharmaceutical and MingMed Biotechnology have both announced significant regulatory achievements that promise to advance treatment options in oncology and aesthetics, respectively.
Fosun Pharma's Oxaliplatin Injection Approved in China
Fosun Pharma's subsidiary, Jisimei (Wuhan) Pharmaceutical Co., Ltd., has received marketing registration approval from China’s National Medical Products Administration (NMPA) for its Oxaliplatin Injection. This independently developed drug is designed for use as a chemotherapeutic agent. Oxaliplatin is a platinum-based chemotherapy drug widely used in the treatment of various cancers, particularly colorectal cancer. The approval marks a significant step in expanding Fosun Pharma's oncology portfolio and providing new treatment options for patients in China.
MingMed's Recombinant Botulinum Toxin Type A Receives FDA IND Approval
MingMed Biotechnology, through its partially owned subsidiary Claruvis Pharmaceutical Co., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for YY003. YY003 is the world's first liquid formulation of recombinant Botulinum Toxin Type A (rBoNT/A), packaged in a pre-filled syringe, and is being developed for the treatment of glabellar lines (frown lines).
According to Dr. Wu Yang, Chief Scientific Officer of Claruvis, this liquid formulation of rBoNT/A offers a safer and more convenient option for users. The combination of a highly effective product and its ease-of-use design aims to provide an optimized solution for BoNT/A users. Claruvis Pharmaceutical has already completed a Phase III clinical trial for the treatment of medium to severe glabellar lines, achieving all study endpoints. The company has also dosed the first patient in a Phase II clinical trial in China for the treatment of adult upper arm spasm, utilizing recombinant BoNT/A for this therapeutic indication. Furthermore, Claruvis has initiated its first Biologics License Application (BLA) in China, supported by comprehensive Phase I, II, and III clinical results.
