Core Viewpoint - Zhonghui Biotech-B (02627.HK) 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] Group 1: Vaccine Development - The RSV vaccine is developed using CHO cells and expresses a modified pre-F protein, showing higher expression levels compared to existing marketed RSV vaccines [1][2] - The pre-F protein expression from the company's high-yield cell line ranges from approximately 1,000 mg/L to 1,500 mg/L, significantly higher than the 600 mg/L to 800 mg/L range of currently available products [2] - The vaccine demonstrates superior thermal stability, maintaining over 95% activity after 14 days at 40°C, while existing products drop to around 50% activity [2] Group 2: Clinical Research and Safety - Preclinical studies indicate that the vaccine has better immunogenicity, with significantly higher geometric mean titers of neutralizing antibodies compared to marketed counterparts [2] - The vaccine has shown good safety profiles in toxicity studies and active systemic allergic reaction tests [2]
中慧生物-B(02627.HK)：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