重庆智翔金泰生物制药股份有限公司自愿披露关于斯乐韦米单抗注射液获得药物临床试验批准通知书的公告

Core Viewpoint - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of its product, Sileweimi Monoclonal Antibody Injection, aimed at passive immunity for children and adolescents aged 2 to 18 suspected of rabies virus exposure [1][2]. Group 1: Drug Information - The drug Sileweimi Monoclonal Antibody Injection is a recombinant fully human bispecific antibody targeting the rabies virus (Rabies Virus, RABV) [2]. - It is classified as a Class 1 therapeutic biological product, with its action target being the glycoprotein (G protein) of RABV [2]. - The drug employs scFv+Fab structure and KIH technology to address heavy chain mismatch issues, and scFv fusion technology to resolve light chain mismatch issues [2]. - It is the world's first bispecific antibody for passive immunity against rabies, designed to ensure effectiveness against different strains or genotypes of the virus [2]. Group 2: Clinical Trial Approval - The clinical trial application for Sileweimi Monoclonal Antibody Injection has been approved for the indication of passive immunity in children and adolescents aged 2 to 18 suspected of rabies virus exposure [1][2]. - The approval is in accordance with the relevant requirements for drug registration under the Drug Administration Law of the People's Republic of China [1]. Group 3: Market Context - As of the announcement date, Sileweimi Monoclonal Antibody Injection is under review for new drug marketing application for adult passive immunity against suspected rabies virus exposure [2]. - Currently, only two rabies virus antibody drugs have been approved for marketing in China [2].