Cspc Innovation Pharmaceutical Co.,Ltd. (300765.SZ) announced that its controlling subsidiary, CSPC Megalith Biopharmaceutical Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) regarding the Investigational New Drug (IND) application for SYS6037 injection, a monkeypox mRNA vaccine.

The vaccine, developed in collaboration with the Institute of Microbiology of the Chinese Academy of Sciences, has been approved by the FDA to proceed with clinical trials 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 mRNA strand, designed for the prevention of monkeypox. Its streamlined technical approach facilitates quality control during production, significantly reduces manufacturing costs, and enhances the vaccine's controllability and accessibility.

Preclinical studies indicate that compared to the live attenuated vaccine (Tiantan strain), SYS6037 injection demonstrates superior immunogenicity and protective efficacy. It also exhibits broad-spectrum cross-reactivity against multiple orthopoxvirus antigens, positioning it as a potentially competitive monkeypox vaccine product that will further diversify the company's mRNA vaccine innovation pipeline.