CSPC PHARMA Initiates Phase I Clinical Trial for Recombinant RSV Vaccine SYS6057 in China

Bulletin Express11-02 19:02

CSPC Pharmaceutical Group Limited (CSPC PHARMA) has commenced a Phase I clinical study of SYS6057, its in-house developed recombinant respiratory syncytial virus (RSV) vaccine produced in Chinese Hamster Ovary (CHO) cells. The trial follows the Notice of Approval for Clinical Trial of Drug granted by China’s National Medical Products Administration in July 2026.

The randomized, blinded, placebo-controlled trial targets adults aged 18 and above and is designed to evaluate safety and immunogenicity. Recruitment and screening of participants are currently in progress.

Pre-clinical pharmacodynamics, pharmacokinetics and toxicology investigations have been completed, demonstrating strong protection against both RSV A and RSV B subtypes, high neutralising antibody titres and sustained immune responses.

The initiation of SYS6057’s first-in-human trial marks a key development milestone for CSPC PHARMA’s vaccine pipeline as the company expands into preventative therapeutics for respiratory infections.

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