人民财讯7月29日电，智翔金泰(688443)7月29日晚间公告，公司收到国家药品监督管理局核准签发的 《药物临床试验批准通知书》，公司在研产品斯乐韦米单抗注射液2岁至18岁以下儿童和青少年疑似狂 犬病病毒暴露后的被动免疫适应症的临床试验申请获得批准。 ...

Group 1 - The company, Zhixiang Jintai (688443.SH), has received approval from the National Medical Products Administration for the clinical trial of its product, Sileweimi Monoclonal Antibody Injection [1] - The clinical trial is aimed at evaluating the passive immunity indication for children and adolescents aged 2 to 18 years who are suspected of rabies virus exposure [1]

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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，重庆智翔金泰生物制药股份有限公司（以下简称"公司"）收到国家 药品监督管理局核准签发的《药物临床试验批准通知书》，公司在研产品斯乐韦 米单抗注射液 2 岁至 18 岁以下儿童和青少年疑似狂犬病病毒暴露后的被动免疫 适应症的临床试验申请获得批准。现将相关情况公告如下： 一、药品基本信息 药品名称：斯乐韦米单抗注射液 申请事项：境内生产药品注册临床试验 证券代码：688443 证券简称：智翔金泰 公告编号：2025-029 斯乐韦米单抗注射液是全球首个用于狂犬病被动免疫的双特异性抗体，分子 设计满足 WHO 关于抗狂犬病病毒抗体开发的建议——采用针对不同抗原位点 的多株单抗组合成"鸡尾酒式"组合制剂，以保证对不同病毒株或病毒的不同基 因型的有效性。 截至本公告披露日，斯乐韦米单抗注射液用于成人疑似狂犬病病毒暴露后的 被动免疫适应症正处于新药上市申请审评中。经公开信息查询，国内仅有 ...

（原标题：智翔金泰(688443.SH)：斯乐韦米单抗注射液获药物临床试验批准） 智通财经APP讯，智翔金泰(688443.SH)公告，公司收到国家药品监督管理局核准签发的《药物临床试 验批准通知书》，公司在研产品斯乐韦米单抗注射液2岁至18岁以下儿童和青少年疑似狂犬病病毒暴露 后的被动免疫适应症的临床试验申请获得批准。 ...

每经AI快讯，7月29日，智翔金泰(688443.SH)公告称，公司在研产品斯乐韦米单抗注射液2岁至18岁以 下儿童和青少年疑似狂犬病病毒暴露后的被动免疫适应症的临床试验申请获得批准。斯乐韦米单抗注射 液是一款由公司自主研发的重组全人源抗狂犬病病毒双特异性抗体，注册分类为治疗用生物制品1类。 ...

智翔金泰7月29日公告， 近日，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》，公司在研产品斯乐韦米单抗注射液2岁至18岁以下儿童和青少年疑似狂犬病病毒暴露后的被动免 疫适应症的临床试验申请获得批准。斯乐韦米单抗注射液为全球首个用于狂犬病被动免疫的双特异性抗 体，分子设计满足WHO关于抗狂犬病病毒抗体开发的建议。 ...

格隆汇7月29日丨智翔金泰(688443.SH)公布，收到国家药品监督管理局核准签发的《药物临床试验批准 通知书》，公司在研产品斯乐韦米单抗注射液2岁至18岁以下儿童和青少年疑似狂犬病病毒暴露后的被 动免疫适应症的临床试验申请获得批准。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its product, SLEWEMI monoclonal antibody injection, aimed at passive immunity for children and adolescents exposed to suspected rabies virus [1] Group 1 - The clinical trial application for SLEWEMI monoclonal antibody injection has been approved for children aged 2 to 18 years [1] - SLEWEMI monoclonal antibody injection is the world's first bispecific antibody for passive immunity against rabies [1] - The molecular design of SLEWEMI meets the World Health Organization's recommendations for the development of rabies virus antibodies [1]

Group 1 - The A-share biopharmaceutical sector experienced a significant afternoon rally, with notable increases in stock prices [1] - Zhifei Biological surged over 14%, while Watson Bio rose more than 12% [1] - Other companies such as Kangtai Biological, Sanyuan Gene, Bohui Innovation, Baike Biological, and Zhixiang Jintai also saw gains [1]

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board 100 Index rose by 0.46% as of July 17, 2025, with notable increases in constituent stocks such as Shengyi Electronics (up 13.37%) and Baiotai (up 6.51%) [1] - The Huaxia Sci-Tech 100 ETF (588800) also saw a rise of 0.50%, marking its fifth consecutive increase, with a latest price of 1 yuan and a trading volume of 27.1854 million yuan [1] - The latest scale of the Huaxia Sci-Tech 100 ETF reached 2.934 billion yuan [1] Group 2 - The adjustment of the national basic medical insurance and commercial health insurance innovative drug catalog officially started, with eligible applicants able to submit online applications from July 11 to 20 [1] - The domestic policy continues to favor innovative drugs, establishing a dynamic adjustment mechanism for new drug access to the medical insurance catalog [2] - The expenditure of employee medical insurance funds increased from 1.29 trillion yuan in 2020 to 1.91 trillion yuan in 2024, reflecting a growth of over 600 billion yuan in five years, indicating a rising demand for pharmaceuticals [2]