登录新浪财经APP 搜索【信披】查看更多考评等级 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、准确性和完整性依法承担法律责任。 辽宁成大生物股份有限公司（以下简称"公司"）全资子公司成大生物（本溪）有限公司（以下简称"本 溪子公司"）于近日收到国家药品监督管理局签发的冻干人用狂犬病疫苗（人二倍体细胞）（以下简 称"人用二倍体狂犬疫苗"）《药品注册证书》。现将相关情况公告如下： 药品批准文号：国药准字S20260012 药品批准文号有效期：至2031年02月09日 上市许可持有人：成大生物（本溪）有限公司 生产企业：成大生物（本溪）有限公司 证书编号：2026S00502 一、药品基本情况 药品名称：冻干人用狂犬病疫苗（人二倍体细胞） 剂型：注射剂 规格：按标示量复溶后每瓶1.0ml。每1次人用剂量为1.0ml，狂犬病疫苗效价应不低于2.5IU。 批准事项：药品注册（境内生产） 注册分类：预防用生物制品 三、对公司的影响 辽宁成大生物股份有限公司 本次本溪子公司人用二倍体狂犬疫苗获批上市，将进一步完善公司疫苗产品布局，增强核心竞争力，巩 固在狂犬病疫苗领 ...

Core Viewpoint - The company Zhonghui Biotech-B (02627) has initiated Phase III clinical trials for its lyophilized rabies vaccine (human diploid cells) aimed at three immunization regimens, marking a significant step in its vaccine development process [1] Group 1: Clinical Trial Progress - The company received approval from the National Medical Products Administration of the People's Republic of China for new drug clinical trials for the Essen (five-dose) regimen in November 2022 [1] - In April 2023, the company obtained approval for supplementary clinical trial applications for the Zagreb (four-dose) and simplified four-dose regimens [1] - The company completed Phase I clinical trials for the rabies vaccine in October 2024 [1] Group 2: Vaccine Characteristics - Rabies is a severe viral disease caused by the rabies virus, leading to serious symptoms such as confusion and progressive paralysis, which are almost always fatal once symptoms appear [1] - Immediate vaccination after exposure to the virus can prevent rabies [1] - The rabies vaccine developed using human diploid cells is recognized as the "gold standard" rabies vaccine by the World Health Organization, demonstrating strong safety profiles [1] - The rabies vaccine has shown good safety characteristics in the completed Phase I clinical trials [1]

Group 1 - Zhonghui Biotech (02627) has successfully held the launch meeting for the Phase III clinical trial of its lyophilized human rabies vaccine (human diploid cells) in Hubei, marking a significant step towards successful commercialization of this core product [1] - Rabies is a zoonotic disease caused by the rabies virus (RABV), with a widespread geographical distribution affecting over 150 countries and regions, posing a severe threat to human life due to nearly 100% mortality once symptoms appear [1] - The onset of rabies symptoms is related to the speed at which the virus moves to the central nervous system, typically occurring 20 to 60 days post-infection, leading to acute encephalomyelitis and subsequent respiratory and circulatory failure [1] Group 2 - Currently, there is no effective treatment for rabies, making prevention crucial, with vaccination being the most effective control measure [2] - Human diploid cell rabies vaccine (HDCV) has a history of over 40 years of use in Europe and North America, with its safety and efficacy well-validated, recognized internationally as the "gold standard" for rabies vaccines [2] - The lyophilized human rabies vaccine (human diploid cells) has completed Phase I clinical trials, showing good safety profiles for both the Essen and Zagreb vaccination protocols in individuals aged 10 to 60 [2]

Group 1 - Zhonghui Biotech (02627) has successfully held the launch meeting for the Phase III clinical trial of its lyophilized human rabies vaccine (human diploid cells) in Hubei, marking a significant step towards successful commercialization of this core product [1] - Rabies is a highly infectious disease caused by the rabies virus (RABV), with a global presence in over 150 countries and regions, posing a severe threat to human life due to nearly 100% mortality once symptoms appear [2] - The human diploid cell rabies vaccine (HDCV) has a history of over 40 years of application in Europe and North America, with its safety and efficacy well-validated, recognized internationally as the "gold standard" for rabies vaccines [2]