CSPC PHARMA (01093.HK): Recombinant respiratory syncytial virus vaccine SYS6057 approved for clinical trials in the US

NewTimeSpace News: On 25 August 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) announced that the recombinant respiratory syncytial virus vaccine (SYS6057), a Class 1 preventive biological product developed by the Group, has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States; the product had previously received approval from the National Medical Products Administration (NMPA) of China to conduct clinical trials on 30 July 2026.

The announcement stated that the product is the Group's second recombinant protein vaccine product approved for clinical trials, comprising the respiratory syncytial virus (RSV) pre-fusion F (Pre-F) protein antigen and the Group's self-developed second-generation nano-adjuvant system. Compared with previous products, the adjuvant of this product adopts a different nano-carrier, presenting unique physicochemical properties and immunological activity; through optimization of the adjuvant system, the product can simultaneously induce high-titer neutralizing antibodies against RSV and potent cellular immune responses, and preclinical studies demonstrated favorable safety and efficacy.

The approved clinical indication is the prevention of RSV-associated lower respiratory tract disease (LRTD) in people aged 60 and above. The clinical trial approval lays a solid foundation for the Group's subsequent development of recombinant protein vaccines and adjuvant products, marking a new stage of rapid development for the Group's vaccine R&D pipeline.

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