China approves CSPC Pharma's RSV vaccine for clinical trials

[July 12, 2024]  SHANGHAI (Reuters) - China's National Medical Products Administration has given regulatory clearance for CSPC Pharmaceutical Group's respiratory syncytial virus (RSV) vaccine candidate to begin human clinical trials, the drugmaker said.

RSV, which shows symptoms similar to a cold but can be fatal for young children and older adults, contributed to 17.6% of one group of patients in Beijing dying within 60 days compared to 7.5% for a group with influenza A virus infection.

Drugs are approved for RSV in China, but there are no vaccines available.

"The product is at the forefront in the research and development progress in China," CSPC said in a stock exchange filing on Thursday.

Like the RSV vaccine from competitor Moderna approved in the United States, CSPC's shot SYS6016 is based on synthetic messenger RNA (mRNA) technology that was popularized during the Covid-19 pandemic.

CSPC is one of few drugmakers in China to receive global approvals for Covid-19 mRNA vaccines and the first to roll out in the world's second-most populous country, which has a rapidly ageing society. CSPC plans to launch an RSV shot in 2026.

SYS6016 displayed "good protection" against against RSV-A and RSV-B subtype viral strains with a "good safety profile", CSPC added. Preclinical studies, it said, showed the shot induced "long-lasting" antibodies.

(Reporting by Andrew Silver; Editing by Sonia Cheema)

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