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.
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15
Eisai begins rolling sBLA to US FDA for initiation dosing of LEQEMBI IQLIK
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
BeOne Medicines reports positive topline data for sonrotoclax in mantle cell lymphoma
Cinclus Pharma to launch Phase III trial of linaprazan glurate in erosive GERD