CSPC Pharma Secures NMPA Clearance to Begin Clinical Trials for Second Recombinant RSV Vaccine

Bulletin Express

Jul 31

CSPC Pharmaceutical Group Limited (CSPC Pharma) has received approval from China’s National Medical Products Administration to commence clinical testing of its Recombinant Respiratory Syncytial Virus (RSV) Vaccine, designated SYS6057.

The green light marks CSPC Pharma’s second recombinant protein vaccine to reach the clinical-trial stage. SYS6057 leverages the RSV prefusion F (Pre-F) protein antigen alongside a next-generation nano-adjuvant system developed in-house. Compared with the group’s prior formulations, the new nanocarrier delivers distinct physicochemical and immunological characteristics, enabling simultaneous induction of high-titre neutralising antibodies and strong cellular immunity against RSV. Pre-clinical studies reported favourable safety and efficacy results.

The upcoming trial targets prevention of lower respiratory tract disease caused by RSV in individuals aged 60 and above. Management characterised the approval as a “new stage of rapid development” for the firm’s vaccine pipeline, underscoring progress in both recombinant protein technologies and proprietary adjuvant platforms.

The board is chaired by Mr. Cai Dong Chen. The announcement was released on 31 July 2026 in Hong Kong.

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