China Approves World’s First Bispecific Antibody for Rabies Passive Immunization

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โดย GlobeNewswire·Read original
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China’s National Medical Products Administration has approved Silevimig Injection, a Class 1 therapeutic biological product from China Medical System Holdings, for passive immunization in adults following rabies virus exposure. The drug is the world’s first fully human bispecific antibody targeting dual epitopes of the rabies virus, consistent with WHO recommendations for a cocktail therapeutic paradigm. It demonstrated non-inferior protective efficacy compared with human rabies immune globulin in a Phase III trial and is the smallest-dose passive immunization product for rabies, reducing injection volume and patient pain. The approval expands CMS’s commercialized innovative drug portfolio to eight products, with six more under marketing review and about 20 in clinical development. CMS holds exclusive commercialization rights in mainland China and exclusive licensing rights for the rest of Asia-Pacific, the Middle East, and North Africa under a 2025 agreement with Chongqing Genrix Biopharmaceutical.

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CMS's bispecific antibody Silevimig approved, world's first for rabies passive immunization, expanding innovative drug portfolio.

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