北京万泰生物药业股份有限公司关于重组三价轮状病毒亚单位疫苗(大肠埃希菌)临床试验申请获得受理的公告

Group 1 - The core announcement is that Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. has received acceptance for its clinical trial application for the recombinant trivalent rotavirus subunit vaccine (E. coli) from the National Medical Products Administration [1][2] - The vaccine is developed in collaboration with Xiamen University and is designed to prevent rotavirus gastroenteritis, utilizing a recombinant protein vaccine technology based on an E. coli expression system [1][2] - The company has invested approximately 65.85 million RMB in the development of this vaccine project as of November 30, 2025 [2] Group 2 - The acceptance of the clinical trial application marks a significant step in the company's innovative vaccine development process, enhancing its product portfolio and market competitiveness [2] - The company has also announced the approval of an HIV antibody oral mucosal exudate self-test kit, which is the first of its kind in China, further establishing its leadership in the HIV self-testing market [7][8] - This HIV self-test kit is expected to improve accessibility to HIV testing and contribute to public health efforts, aligning with national strategies for HIV prevention and control [9][10]