China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary Evive Biotech Ltd’s F-652 has been cleared to start a Phase II clinical trial for a new indication by China’s National Medical Products Administration (NMPA). The trial will assess F-652 as a treatment for alcoholic hepatitis (AH).
Mechanism and Development of F-652
F-652 is a first-in-class recombinant human interleukin 22-Fc fusion protein, expressed by Chinese hamster ovary cells (CHO cells) using genetic engineering technology. Its protein activity mechanism completely mimics human interleukin (IL)-22, with the Fc fragment extending the half-life of IL-22 from 2 hours to 66 hours, thereby significantly improving the efficacy.
Clinical Trials and Regulatory Milestones
F-652 has successfully concluded Phase IIa clinical studies in acute graft versus host disease (GvHD) and alcoholic hepatitis, as well as three Phase I clinical trials in Australia, China, and the US, all of which have reached pre-set endpoints. The drug was awarded orphan drug designation (ODD) status in GvHD in the US in October 2019 and obtained clinical trial approval to treat acute chronic liver failure (ACLF) in September 2021.-Fineline Info & Tech
