CSPC Innovation Pharmaceutical (300765.SZ) subsidiary SYS6037 injection (monkeypox mRNA vaccine) has received approval for clinical trials in the United States.

CSPC Innovation Pharmaceutical (300765.SZ) announced that its holding subsidiary CSPC PHARMA Giant Stone Biopharmaceutical Co., Ltd. (hereinafter referred to as "Giant Stone Biopharma") has recently received notice from the U.S. Food and Drug Administration (hereinafter referred to as "FDA") that the clinical trial application for SYS6037 injection (monkeypox mRNA vaccine), developed in collaboration with the Institute of Microbiology, Chinese Academy of Sciences, has been approved by the FDA, allowing clinical trials to be conducted in the United States. Monkeypox is caused by the monkeypox virus, which belongs to the Orthopoxvirus genus of the Poxviridae family. SYS6037 injection is a multi-antigen monkeypox vaccine encoded by a single-stranded mRNA, intended for the prevention of monkeypox. Its technical route is straightforward, facilitating quality control in the production process while significantly reducing production costs, thereby improving the vaccine's controllability and accessibility. Preclinical studies have shown that, compared to the live attenuated vaccine (Tian Tan strain), SYS6037 injection exhibits superior immunogenicity and protective efficacy and demonstrates broad cross-reactivity against various orthopoxvirus antigens, making it a potentially competitive monkeypox vaccine product and further enriching the company's pipeline of innovative mRNA vaccine products.