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CSPC achieves key regulatory milestones for weight management and immunosuppressant drugs

October 13, 2025 at 11:00 AM UTCBy FilingReader AI

CSPC Pharmaceutical Group Limited announced that its new drug application for Efmedaglutide Alfa Injection has been accepted by China's National Medical Products Administration (NMPA). Developed by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd., this Class 1 therapeutic biological product targets long-term weight management in overweight or obese adults. It is currently undergoing two Phase III clinical trials for type 2 diabetes patients.

Additionally, CSPC obtained drug registration approval from the NMPA for its Tacrolimus Extended-release Capsules (0.5mg, 1mg). This product is indicated for the prophylaxis and treatment of graft rejection after kidney and liver transplantation, enriching the group's immunological rejection therapeutic portfolio. Both announcements were made on 13 October 2025, according to filings from Hong Kong.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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