康华生物正式启动重组六价诺如病毒疫苗Ⅰ期临床试验 首例受试者成功入组

Core Viewpoint - Chengdu Kanghua Biological Products Co., Ltd. has officially launched Phase I clinical trials for its recombinant hexavalent norovirus vaccine (Pichia pastoris) in mainland China, marking a significant step in addressing the lack of approved treatments or preventive vaccines for norovirus infections [1] Group 1: Vaccine Development - The recombinant hexavalent norovirus vaccine is an innovative vaccine constructed using genetic engineering technology based on virus-like particles (VLPs), theoretically capable of preventing over 90% of norovirus infections and the acute gastroenteritis they cause [1] - The Phase I clinical trial aims to evaluate the safety and immunogenicity of the vaccine in healthy individuals aged 6 weeks and older, utilizing a randomized, double-blind, placebo-controlled design [1] Group 2: Market Context - Norovirus is a major pathogen responsible for acute gastroenteritis outbreaks across all age groups, and its prevention has garnered significant attention [1] - Currently, there are no approved therapeutic drugs or preventive vaccines for norovirus globally, indicating a substantial market opportunity for Kanghua's vaccine development [1] Group 3: Future Plans - The company plans to accelerate the clinical research process for the vaccine, aiming for steady progress in its development efforts [1]