Shanghai Junshi Biosciences Co.,Ltd. (688180.SH) announced that its controlling subsidiary, Shanghai Juntuo Biomedical Technology Co., Ltd., has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The clinical trial application for JT118 injection has been approved, with the National Medical Products Administration agreeing to commence clinical trials for the prevention of monkeypox virus infection.
JT118 is a "2-in-1" recombinant protein vaccine composed of tandem fusion of monkeypox virus antigens A35 (extracellular enveloped virus antigen) and M1 (intracellular mature virus antigen), primarily intended for preventing monkeypox virus infection.
Monkeypox is a zoonotic viral disease caused by monkeypox virus infection. The monkeypox virus is classified under the genus Orthopoxvirus of the Poxviridae family. During poxvirus replication, two morphologically different viral particles are produced: extracellular enveloped viruses and intracellular mature viruses, both of which are infectious.
JT118 not only preserves the epitope structures of both natural antigens A35 and M1, but also significantly increases the molecular weight through multi-antigen fusion, making it more conducive to immune stimulation.