Shutai Shen Announces First Patient Dosed in Ib/II Clinical Trial of STSG-0002 Injection for Chronic Hepatitis B

Staidson (300204.SZ) announced that the company and its wholly-owned subsidiary, Beijing SoloBio Genetechnology Company Ltd. ("SoloBio"), had previously disclosed the Phase Ib/II clinical trial information for the gene drug "STSG-0002 Injection" intended for treating diseases related to hepatitis B virus infection on the National Medical Products Administration's Center for Drug Evaluation platform for clinical trial registration and information disclosure in February 2023. Recently, the first subject dosing in the Phase Ib/II clinical trial for chronic hepatitis B indication of STSG-0002 Injection was completed at Peking University First Hospital.

The announcement shows that STSG-0002 injection is a Class I therapeutic biologic product with independent intellectual property rights in China, and its clinical trial indication is chronic hepatitis B. STSG-0002 injection is a liver-targeting replication-defective recombinant adeno-associated virus carrying shRNA expression cassettes targeting the P and X regions of the HBV genome. It specifically silences pgRNA associated with HBV replication and sRNA related to HBV protein expression, blocking HBV replication and reducing the synthesis and secretion of HBsAg, HBeAg, and HBc proteins. STSG-0002 exhibits significant liver tropism, allowing long-term expression of siRNA in hepatocytes with a single intravenous administration. The substantial reduction in HBsAg is expected to promote HBsAg seroconversion, effectively decreasing chronic inflammation caused by HBV replication in the livers of HBV carriers, thereby preventing the progression of chronic hepatitis B patients to severe liver diseases such as cirrhosis and liver cancer, achieving functional cure of HBV.