格隆汇1月26日丨康华生物（维权）(300841.SZ)公布，公司研发的重组六价诺如病毒疫苗（毕赤酵母） 在中国大陆正式启动Ⅰ期临床试验，并完成首例受试者入组。重组六价诺如病毒疫苗（毕赤酵母）适用 于预防诺如病毒感染及其引起的急性肠胃炎。诺如病毒是全球范围内引起全年龄段人群急性肠胃炎流行 及暴发的主要病原体之一，目前全球范围内尚无对症治疗药物或预防疫苗产品获批上市。公司重组六价 诺如病毒疫苗（毕赤酵母）是采用基因工程技术构建的基于病毒样颗粒（VLPs）的创新型疫苗，适用 于预防诺如病毒感染及其引起的急性肠胃炎，理论上可以预防90%以上的诺如病毒感染及其引起的急性 肠胃炎。 ...

康华生物公告，近日，公司研发的重组六价诺如病毒疫苗（毕赤酵母）在中国大陆正式启动Ⅰ期临床试 验，并完成首例受试者入组。重组六价诺如病毒疫苗（毕赤酵母）是采用基因工程技术构建的基于病毒 样颗粒（VLPs）的创新型疫苗，适用于预防诺如病毒感染及其引起的急性肠胃炎，理论上可以预防 90%以上的诺如病毒感染及其引起的急性肠胃炎。 ...

Group 1 - The core focus of the news is the initiation of the Phase II clinical trial for the six-valent recombinant norovirus vaccine developed by YuanDa Life Sciences, which is the fastest progressing norovirus vaccine globally [1][2] - The vaccine utilizes virus-like particle (VLP) technology, covering six globally prevalent genotypes, theoretically addressing over 90% of circulating norovirus strains [1] - Norovirus is a major pathogen causing acute gastroenteritis, characterized by rapid mutation and high transmissibility, with a significant clinical demand for effective vaccines as no specific antiviral drugs or preventive vaccines are currently approved [1] Group 2 - The Phase II clinical trial launch meeting was hosted by experts from the Guangxi Disease Control Center, emphasizing collaboration and adherence to ethical and trial standards to ensure scientific and efficient progress [2] - According to Frost & Sullivan, the market for norovirus vaccines in China is projected to grow from 1.53 billion yuan to 22.93 billion yuan between 2026 and 2031, with a compound annual growth rate of 71.85% [2] - YuanDa Saiweixin is recognized as a leading innovative vaccine company in China, with a comprehensive international industrial layout and a robust pipeline of over ten innovative vaccine projects [3] Group 3 - The company has established four proprietary technology platforms, including recombinant protein VLP and new adjuvants, which form a solid foundation for research and development [3] - A vaccine production base that meets global high standards is under construction in Hangzhou, expected to support the commercialization of 8 to 10 new vaccines, with an anticipated annual output value exceeding 10 billion yuan [3]