Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-12-26 03:41Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. has received approval from the National Medical Products Administration for the registration of its lyophilized rabies vaccine (Vero cells), which will enhance the company's product portfolio and competitiveness in the vaccine market [1][4]. Group 1: Drug Basic Information - The drug is a lyophilized rabies vaccine (Vero cells) intended for human use, administered as an injection with a dosage of 0.5ml per dose, and must have a potency of no less than 2.5 IU [1][2]. - The registration classification is for preventive biological products, with the approval number being 2025S03950, and the approval is valid until December 21, 2030 [2]. Group 2: Drug Development and Market Context - The vaccine is used to prevent rabies, a serious infectious disease caused by the rabies virus, primarily transmitted through bites or scratches from infected animals [3]. - Baiyunshan Biopharmaceutical has invested approximately RMB 205.09 million in the research and development of the lyophilized rabies vaccine [3]. Group 3: Company Impact - The approval of the rabies vaccine registration certificate will enrich the company's product structure and enhance its competitiveness in the vaccine market [4]. - Baiyunshan Biopharmaceutical plans to actively commence production of the vaccine following the issuance of the biological product batch release certificate by the National Medical Products Administration [4].