On August 17, Zhonghui Bio-B (02627) announced that its independently developed recombinant respiratory syncytial virus vaccine (CHO cells) (adjuvanted) had received approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration and the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This vaccine was developed to target respiratory syncytial virus (RSV), a significant cause of respiratory infections in infants, the elderly, and immunocompromised individuals.

According to the announcement, the company's vaccine demonstrated higher pre-F protein expression levels (approximately 1,000 to 1,500 mg/L) in preclinical studies than the marketed recombinant RSV vaccine (approximately 600 to 800 mg/L for the marketed product). Furthermore, after 14 days at 40°C, the company's pre-F protein activity remained above 95%, while the marketed product's activity decreased to approximately 50%. This demonstrates that the company's vaccine is more stable and immunogenic than similar products. While the company is confident in the successful development and commercialization of the vaccine, the announcement also advises shareholders and potential investors to exercise caution when trading.

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