CSPC Pharma (01093) announced that its investigational new drug, SYS 6037 injection (monkeypox mRNA vaccine), a Class 1 preventive biological product developed in collaboration with the Institute of Microbiology of the Chinese Academy of Sciences, has received approval from the U.S. Food and Drug Administration (FDA) to initiate clinical trials in the United States.

Monkeypox is caused by the monkeypox virus, which belongs to the Orthopoxvirus genus of the Poxviridae family. This product is a multi-antigen monkeypox vaccine encoded by a single mRNA strand, designed for the prevention of monkeypox. Its streamlined technical approach facilitates quality control during production and significantly reduces manufacturing costs, thereby enhancing the vaccine's controllability and accessibility.

Preclinical studies indicate that, compared to the live attenuated Tiantan strain vaccine, this product demonstrates superior immunogenicity and protective efficacy, while also exhibiting broad-spectrum cross-reactivity against multiple orthopoxvirus antigens. The product is expected to become a competitively viable monkeypox vaccine, further enriching CSPC Pharma's innovative mRNA vaccine pipeline.