Hybio Pharmaceutical Partner 3SBio-Mandy's Semaglutide Injection for Weight Loss Accepted for Marketing Application

Regulation
โดย Jiemian·Read original
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Shenzhen Hybio Pharmaceutical Co., Ltd. announced that the domestic manufacturing marketing authorization application for semaglutide injection for weight loss, filed by its partner Zhejiang 3SBio-Mandy Pharmaceutical Co., Ltd., has been formally accepted by the Center for Drug Evaluation of the National Medical Products Administration. A total of five application numbers were accepted, covering the mainstream clinical specifications of the product. In May 2024, Hybio Pharmaceutical signed a cooperation agreement with 3SBio-Mandy, under which Hybio Pharmaceutical acts as the entrusted research, development, and manufacturing party as the marketing authorization holder, while 3SBio-Mandy serves as the marketing authorization holder and commercialization lead. In August 2025, the two parties signed a supplementary agreement clarifying matters such as production supply after product approval. The company stated that this acceptance marks an important milestone in the cooperation. If the product is successfully approved and launched, it will further enhance the company's layout in the GLP-1 peptide drug field. At the same time, it cautioned that the registration application is only at the initial review stage, and there are significant uncertainties regarding final approval and sales performance.

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Hybio Pharmaceutical
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▲ PositiveRegulationrelevance

Marketing application for semaglutide injection accepted by NMPA, a regulatory milestone for Hybio as the R&D and manufacturing partner.

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Zhejiang Sansheng Wandi PharmaceuticalPrivate▲ Positive
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Marketing application for semaglutide injection accepted by NMPA, a regulatory milestone for 3SBio-Mandy as the marketing authorization holder and commercialization lead.

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