Research & Development
Ascletis Pharma's ASC22 (Envafolimab) receives US FDA Investigational New Drug application approval
18 January 2022 -

Ascletis Pharma Inc. (HKEX: 1672), a China-based R&D driven biotech company, announced on Monday that it has received the Investigational New Drug (IND) application approval from United States Food and Drug Administration (FDA) and started global development of ASC22 (Envafolimab), a first-in-class, subcutaneously administered PD-L1 antibody for the functional cure of chronic hepatitis B.

The product has undergone the ASC22 Phase IIb study (ClinicalTrials.gov Identifier: NCT04465890), a randomised, single-blind, placebo-controlled, multi-centre clinical trial in China that assessed the efficiency and safety of 149 chronic hepatitis B patients for 24-week treatment of 1mg/kg or 2.5mg/kg ASC22 or matching placebo offered once every two weeks along with NAs.

Ascletis Pharma Inc has received a global and exclusive license effective 8 November 2021 from Suzhou Alphamab to develop and commercialise ASC22 for all viral diseases including Hepatitis B.

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