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On January 17, Ascletis announced that the IND application for subcutaneous injection of PD-L1 antibody ASC22 (envolimumab) was approved in the United States for chronic hepatitis
B.
ASC22 is a First-in-class subcutaneously injected PD-L1 antibody for functional cure of chronic hepatitis B.
It is also the fastest clinically developed immunotherapy for chronic hepatitis B by blocking PD-1/PD-L1 pathway in the world.
.
At the 2021 annual meeting of the American Association for the Study of Liver Diseases (AASLD), the Phase IIa and Phase IIb clinical studies of ASC22 for functional cure of hepatitis B were selected as the "Best Abstract of the Conference"
Phase IIb trial (clinical trial number: NCT04465890) is a randomized, single-blind, placebo-controlled, multicenter clinical trial in China evaluating 1 mg/kg every 2 weeks for 24 weeks in patients with chronic hepatitis B Safety and efficacy of 2.
5 mg/kg ASC22 or placebo in combination with nucleoside (acid) analogs
.
RESULTS: Among patients with baseline HBsAg ≤500 IU/mL, approximately 19% (3/16) of patients in the treatment group had sustained HBsAg loss, whereas no patients in the placebo group achieved HBsAg loss, and in ASC22 There was no rebound after stopping the drug, showing functional cure of hepatitis
In January 2019, Ascletis and Corning Jereh reached a partnership for the first time and obtained the Greater China rights of ASC22
.
On November 8, Ascletis announced that it has expanded its cooperation with Corning Jeremy again to expand the cooperation of nvolimumab for viral diseases including hepatitis B to the world
