Ascletis Pharma Inc. (HKEX code: 1672) announces today the application for in-house developed Category 1 Drug ASC41 for clinical trials of NASH indication has been accepted by China’s National Medical Products Administration (NMPA).
ASC41 is expected to be used in combination with ASC40, another innovative drug of the Company, for treatment of NASH. ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist, while ASC40 is an oral fatty acid synthase (FASN) inhibitor.
“We are excited about the clinical trial application of ASC41, the 1st in-house developed candidate drug for NASH, is accepted by NMPA,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. “Ascletis is an innovative R&D driven biotech company, we are rapidly moving from ‘First-in-China‘ to ‘First-in-Class’.”
Ascletis also has diverse pipelines for series of antiviral drugs. In the field of HBV, ASC22 is a first-in-class PD-L1 antibody candidate drug for chronic hepatitis B on global basis, by blocking the PD-1/PD-L1 pathway to effectively improve the function of specific T-cell and have subcutaneous injection and room temperature stability characteristics. Recently, Ascletis had received the approval to conduct clinical trials in chronic hepatitis B patients by NMPA.