Yifang Biotechnology (688382.SH): D-2570 approved to conduct Phase II clinical trials for psoriasis in the United States.

Yifang Biopharmaceutical (688382.SH) announced that the company's application for a Phase II clinical trial of D-2570 as a single drug treatment for Psoriasis (PsO) submitted to the U.S. Food and Drug Administration (FDA) has reached the 30-day default period recently, with no objections received from the FDA. According to relevant regulations, the Phase II clinical trial of D-2570 as a single drug treatment for PsO in the United States has officially been approved. D-2570 is a novel oral selective inhibitor targeting tyrosine kinase 2 (TYK2) independently developed by the company for the treatment of autoimmune diseases such as Psoriasis. The company's application to the U.S. FDA is for a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of D-2570 in patients with moderate to severe plaque Psoriasis. The main endpoint of the study is to assess the proportion of participants who achieve at least a 90% improvement in Psoriasis Area and Severity Index (PASI) at week 12 of treatment compared to baseline. Previously, the company has completed a Phase II clinical trial of D-2570 for Psoriasis in China, with results showing significant efficacy in lesion clearance and improvement in disease severity compared to the placebo group at week 12 of treatment, with overall good safety and tolerability. Based on the positive efficacy data and good safety data of D-2570, the company is actively expanding clinical exploration of D-2570 in multiple autoimmune disease areas. In May 2025, the company administered the first dose to a patient in a Phase II clinical trial for ulcerative colitis, which is currently ongoing as planned; in September of the same year, the company reached an agreement with the National Medical Products Administration on the protocol for a Phase III clinical trial of D-2570 for treating Psoriasis, with patient enrollment in the Phase III trial underway as planned. The company is also simultaneously conducting clinical trials of D-2570 for other indications, including Psoriatic arthritis and systemic lupus erythematosus, which are ongoing as planned.