CSPC Pharmaceutical Group Ltd. announced that the National Medical Products Administration (NMPA) of China has accepted the new drug application for Efmedaglutide Alfa Injection. Developed by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd., a subsidiary of CSPC, the drug is intended for long-term weight management in overweight or obese adults, in conjunction with diet and increased physical activity. The submission is based on pivotal Phase III clinical trial results demonstrating significant weight reduction and improved metabolic indicators, along with a favorable safety profile. The regulatory review is currently ongoing. No other organizations are noted as recipients of this regulatory acceptance.
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