Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has reported positive outcomes from a Phase II clinical trial for F-652, a product developed by its subsidiary Evive Biotech Ltd, in the treatment of acute-on-chronic liver failure (ACLF). The trial demonstrated that F-652 not only exhibits good safety and pharmacokinetic/pharmacodynamic (PK/PD) properties in patients with hepatitis B complicated with ACLF but also suggests that it may offer more significant clinical efficacy than current treatment methods.
F-652, produced using genetic engineering technology in Chinese hamster ovary (CHO) cells, has a protein activity mechanism that closely mirrors human interleukin (IL)-22. The Fc fragment in F-652 extends the half-life of IL-22 from 2 hours to 66 hours, thereby markedly enhancing its efficacy.
Having completed Phase IIa clinical studies in acute graft versus host disease (GvHD) and alcoholic hepatitis (AH), along with three Phase I clinical trials in Australia, China, and the US, F-652 has consistently shown good safety, tolerability, and preliminary efficacy. The drug received orphan drug designation (ODD) status in GvHD from the US in October 2019.- Fineline.com
