CSPC Pharma secures U.S. FDA clearance for Phase I trial of second recombinant RSV vaccine SYS6057

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CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration for its recombinant respiratory syncytial virus (RSV) vaccine candidate, SYS6057. The product had earlier obtained clinical-trial clearance from China’s National Medical Products Administration on 30 July 2026.

SYS6057 is the company’s second recombinant protein vaccine to reach the clinical-trial stage. The candidate comprises the prefusion F (Pre-F) protein antigen of RSV combined with CSPC Pharma’s proprietary second-generation nano-adjuvant system. Compared with the firm’s prior vaccine, the new formulation leverages a different nanocarrier engineered to deliver distinctive physicochemical and immunological attributes.

Preclinical studies cited in the announcement show favorable safety and efficacy profiles, with the optimized adjuvant inducing both high-titre neutralising antibodies and robust cellular immune responses against RSV. The authorised indication for the upcoming U.S. trial targets prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and above.

Management stated that the latest clearance strengthens the foundation for CSPC Pharma’s recombinant protein vaccine and adjuvant portfolio, marking a transition to an accelerated development phase for the company’s vaccine pipeline.

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