Shang Hai Zheng Quan Bao·2025-12-25 18:49Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Biological Products Co., Ltd., has received a drug registration certificate for the lyophilized human rabies vaccine (Vero cells) from the National Medical Products Administration [1][2]. Group 1: Drug Information - The drug is a lyophilized human rabies vaccine (Vero cells) intended for the prevention of rabies, with a dosage of 0.5ml per injection and a potency of not less than 2.5 IU per dose [1][3]. - The registration certificate number is 2025S03950, and the approval number is 国药准字S20250069, valid until December 21, 2030 [2]. Group 2: Development and Investment - Baiyunshan Biological submitted the drug registration application on July 19, 2024, and received acceptance on July 25, 2024 [3]. - The company has invested approximately RMB 205.09 million (20,509 thousand) in the research and development of the lyophilized human rabies vaccine [3]. Group 3: Market Impact - The approval of the rabies vaccine registration certificate will enhance the company's product portfolio and competitiveness in the vaccine market [4]. - Baiyunshan Biological plans to actively commence production of the vaccine, which can be marketed after obtaining the biological product batch release certificate from the National Medical Products Administration [4].