Junshi Biotech (01877): Notice of acceptance of JT118 drug clinical trial application

Zhitong Finance App News, Junshi Biotech (01877) issued an announcement. Recently, Shanghai Juntuo Biomedical Technology Co., Ltd., a holding subsidiary of Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the “Company”), received the “Notice of Acceptance” approved and issued by the State Drug Administration, and the clinical trial application for JT118 injection (project code “JT118”) was accepted. Due to the long drug development cycle and many approval processes, it is easily affected by uncertainties. There is uncertainty about whether this clinical trial application can be approved. Investors are kindly requested to make careful decisions and pay attention to preventing investment risks.

JT118 is a “2-in-1” recombinant protein vaccine composed of monkeypox virus antigen A35 (an extracellular capsule virus antigen) and M1 (intracellular mature virus antigen) in tandem. It is intended mainly to prevent monkeypox virus infection. Monkeypox is a zoonotic viral disease caused by infection with the monkeypox virus. The monkeypox virus is classified as the genus Pox virus in the Pox virus family. During the replication process, pox virus produces two types of virus particles: extracellular capsule virus and intracellular mature virus, and both are infectious. JT118 not only retains the epitope structure of two natural antigens, A35 and M1, but also greatly increases molecular weight through multi-antigen fusion, which is more conducive to immune stimulation. Preclinical findings suggest that vaccination of large and small animals with JT118 can produce high levels of binding antibodies, vaccinatory/monkeypox virus neutralizing antibodies, and cellular immune activation. It has significant protective effects on small and large animal models of pox virus/monkeypox virus infection, and is safe.

In October 2023, the company reached a cooperation with Peking University, the Institute of Microbiology of the Chinese Academy of Sciences, the Shanxi Institute of Advanced Innovation, and Beijing University of Aeronautics and Astronautics to jointly develop a monkeypox recombinant protein vaccine. As of the disclosure date of this announcement, no vaccine to prevent monkeypox virus infection has been approved for marketing in China.

Since pharmaceutical products have the characteristics of high technology, high risk, and high added value, early drug development and product cycles and many steps from development and clinical trial approval to commissioning are easily affected by uncertainties. There is uncertainty about whether this clinical trial application can be approved. Investors are kindly requested to make careful decisions and pay attention to preventing investment risks.