News Report – On December 13, the Phase II clinical trial initiation meeting for the hexavalent recombinant norovirus vaccine (a Class 1.1 new drug) independently developed by Vazyme Life Sciences Co., Ltd. (hereinafter referred to as "Vazyme"), a subsidiary of Grand Life Science Group Co., Ltd. (referred to as "Grand Life Science"), was successfully held at the Cenxi City Center for Disease Control and Prevention in Guangxi.

According to the reporter, this vaccine is currently the fastest progressing hexavalent norovirus vaccine in global clinical development. It utilizes virus-like particle (VLP) technology and covers six globally prevalent genotypes, theoretically providing coverage for over 90% of circulating norovirus strains worldwide.

Norovirus is a leading cause of acute gastroenteritis, characterized by rapid mutation, high infectivity, and fast transmission. The period from October to March each year marks the peak season for norovirus infection in China. At present, there are no specific antiviral drugs or preventive vaccines approved globally for norovirus, indicating a substantial unmet clinical need.

To address this gap, Vazyme's vaccine employs VLP technology. This technology uses genetic engineering to express viral shell proteins, which self-assemble into particles that closely resemble the structure of the natural virus but contain no genetic material. This approach effectively stimulates an immune response in the human body without the risk of infection, ensuring significant safety.

Previous preclinical studies and Phase I clinical trial data for Vazyme's hexavalent recombinant norovirus vaccine have demonstrated that it can induce a robust immune response against various genotypes and exhibits excellent safety and tolerability.

The Phase II clinical trial initiation meeting was chaired by Shi Liwei, the principal investigator of the project and a vaccine clinical expert from the Guangxi Center for Disease Control and Prevention. Attendees included Mo Yi, Director of the Vaccine Clinical Research Institute of the Guangxi CDC; Li Jianqiang, Chairman of Vazyme; Chen Hongsen, Director of the Cenxi City CDC; and representatives from collaborating parties. All parties emphasized strengthening collaboration, strictly adhering to ethical and trial standards, ensuring the scientific, standardized, and efficient advancement of the Phase II clinical trial, and prioritizing data quality control and participant protection.

The substantial unmet need also indicates a promising market outlook for norovirus vaccines. According to data from Frost & Sullivan, with the progress in China's norovirus vaccine pipeline development and clinical advancement, the first related product is expected to be approved as early as 2026. From 2026 to 2031, the market size for norovirus vaccines in China is projected to grow from RMB 1.53 billion to RMB 22.93 billion, achieving a compound annual growth rate (CAGR) of 71.85%.

Vazyme is a leading innovative vaccine company in China with advanced technology and a rich pipeline, having established an international vertically integrated industrial layout encompassing R&D, production, and sales. The company possesses four proprietary technology platforms: recombinant protein VLP, novel adjuvants, bacterial gene editing, and small nucleic acids, forming a solid R&D foundation. It currently has over ten Class 1 innovative vaccine pipelines, including several world-first projects. Additionally, the company has begun construction of a globally compliant, high-standard vaccine industrialization base in Hangzhou. In the future, this facility will support the commercial production of 8 to 10 novel vaccines, with an estimated annual output value exceeding RMB 10 billion.

reference：https://finance.eastmoney.com/a/202512143590995098.html