Galenwolizumab is clinically active in the treatment of hepatitis B IIa

October 14, 2021

Hangzhou, China and Shaoxing, October 12, 2021--Gallite Pharmaceutical Co., Ltd. (Hong Kong Stock Exchange code: 1672) today announced its subcutaneous injection of PD-L1 antibody ASC22 (Envolimab) for a phase IIa study of chronic hepatitis B The results will be reported as an oral report at the 2021 American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting® 2021). The American Association for the Study of Liver Diseases Annual Conference is currently one of the most authoritative hepatology conferences in the world. This conference will be held from November 12 to 15 this year. ASC22 (Envolimab) is a PD-L1 monoclonal antibody that is injected subcutaneously. Blocking the PD-1/PD-L1 pathway can restore HBV-specific T cell function, thereby achieving a functional cure for chronic hepatitis B. The ASC22 Phase IIa clinical trial is a single-dose escalation study, using three subcutaneous doses (0.3, 1.0, and 2.5 mg/kg, three patients at each dose), and a 12-week follow-up to explore the effect of ASC22 on the The safety and preliminary efficacy of patients with chronic hepatitis B treated with nucleoside (acid) analogues. Research data showed that after a single administration of ASC22 (0.3, 1.0, 2.5 mg/kg), the patients were followed up for 12 weeks, and the patients with hepatitis B surface antigen (HBsAg) showed a dose-dependent downward trend; among the 3 patients in the 2.5 mg/kg ASC22 dose group Among them, one patient had the highest HBsAg drop of 1.2 log10 IU/mL during the 12-week follow-up period; the three dose groups of ASC22 showed good safety and tolerability, and the adverse reactions during the study period were all grade 1

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