Core Viewpoint - The company has received approval for its self-developed 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 recombinant RSV vaccine is developed using CHO cells and expresses modified pre-F protein, demonstrating higher expression levels compared to existing vaccines [2] - The pre-F protein expression levels for the company's high-yield cell line range from approximately 1,000 mg/L to 1,500 mg/L, significantly higher than the 600 mg/L to 800 mg/L of currently marketed products [2] - The vaccine shows excellent thermal stability, maintaining over 95% activity after 14 days at 40°C, while existing products drop to around 50% activity [2] Group 2: Clinical and Safety Profile - Preclinical studies indicate that the vaccine has superior immunogenicity, with significantly higher geometric mean titers of neutralizing antibodies compared to similar marketed products [2] - The vaccine has demonstrated good safety profiles in toxicity studies and active systemic allergic reaction tests [2] Group 3: Market Context - RSV is a highly infectious RNA virus that poses significant health risks, particularly to infants, the elderly, and immunocompromised individuals, with a high incidence of acute respiratory infections [1] - The lack of effective therapeutic options for RSV has made vaccination a preferred clinical solution for prevention [1]
中慧生物-B：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