Group 1 - The company Zhonghui Biotech-B (02627) has received approval for its IND application for a recombinant respiratory syncytial virus (RSV) vaccine from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) [1][2] - RSV is a highly infectious RNA virus that significantly impacts infants, the elderly, and immunocompromised individuals, being a leading cause of respiratory infections [1] - The vaccine is positioned as a preferred clinical solution for RSV prevention due to the lack of effective therapeutic drugs currently available [1] Group 2 - The vaccine utilizes CHO cells to express a modified pre-F protein, achieving higher expression levels compared to existing marketed RSV vaccines, with production levels between 1,000 mg/L and 1,500 mg/L, compared to 600 mg/L to 800 mg/L for current products [2] - The preclinical studies indicate that the vaccine maintains over 95% activity after 14 days at 40°C, while existing products show a reduction to around 50% [2] - The company's vaccine demonstrates superior immunogenicity in preclinical trials, with significantly higher neutralizing antibody geometric mean titers compared to marketed counterparts, alongside good safety profiles in toxicity studies [2]
中慧生物-B(02627)：重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂)的IND获中国CDE及美国FDA批准