Core Viewpoint - The company has received approval for clinical trials of its recombinant protein vaccine JT118, aimed at preventing monkeypox virus infection, marking a significant step in its vaccine development efforts [1][2]. Group 1: Clinical Trial Approval - The company's subsidiary, Shanghai JunTuo Biopharmaceutical Technology Co., Ltd., has obtained the clinical trial approval notice from the National Medical Products Administration for JT118 [1]. - JT118 is a "two-in-one" recombinant protein vaccine composed of monkeypox virus antigens A35 and M1, designed to enhance immune response [1]. Group 2: Vaccine Development and Research - Preclinical studies indicate that JT118 can generate high levels of neutralizing antibodies and activate cellular immunity in animal models, demonstrating significant protective effects against monkeypox virus infection [1]. - The company has formed collaborations with several prestigious institutions, including Peking University and the Chinese Academy of Microbiology, to jointly develop the monkeypox recombinant protein vaccine [2]. - As of the announcement date, no vaccines for preventing monkeypox virus infection have been approved for market release in China [2].

自愿披露关于 JT118 获得药物临床试验 批准通知书的公告 证券代码：688180 证券简称：君实生物 公告编号：临 2025-044 上海君实生物医药科技股份有限公司 研究院、北京航空航天大学达成合作，共同开发猴痘重组蛋白疫苗。截至本公告 披露日，国内尚无预防猴痘病毒感染疫苗获批上市。 近日，上海君实生物医药科技股份有限公司（以下简称"公司"）控股子公 司上海君拓生物医药科技有限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》，JT118 注射液（项目代号"JT118"）的临床试验申请获 得批准。由于药品的研发周期长、审批环节多，容易受到一些不确定性因素的影 响，敬请广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如下： 一、药品基本情况 药品名称：JT118 注射液 申请事项：境内生产药品注册临床试验 受理号：CXSL2500478 申请人：上海君拓生物医药科技有限公司 审批结论：根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理 法》及有关规定，经审查，2025 年 6 月 11 日受理的 JT118 注射液符合药品注册 的有关要求，同意开展用于预防猴痘病毒感染的临床试验。 ...