湖南华纳大药厂股份有限公司自愿披露关于参股公司收到ZG-002片Ⅰ期临床研究报告的公告

Core Viewpoint - The announcement details the completion of Phase I clinical trials for ZG-002, a novel drug developed by Shanghai Zhigen Pharmaceutical Technology Co., Ltd., which is a subsidiary of Hunan Warner Pharmaceutical Co., Ltd. The drug is aimed at treating moderate to severe plaque psoriasis and has shown promising safety and efficacy results in preliminary studies [1][2]. Drug Overview - ZG-002 is a first-in-class new drug designed to treat autoimmune diseases, specifically targeting moderate to severe plaque psoriasis [1]. - It is characterized as a potent and highly selective TYK2 allosteric inhibitor, demonstrating superior TYK2 inhibition and efficacy in animal models of psoriasis [2]. Phase I Clinical Trial Results - The primary objective of the Phase I clinical trial was to assess the safety, tolerability, pharmacokinetics, and food effects of ZG-002 in healthy adult subjects [3]. - Results indicated good safety and tolerability, with no serious adverse events reported. Adverse events related to the drug were mild (Grade 1 or 2) and transient [4]. - Pharmacokinetic data showed a clear relationship between drug exposure and dosage, with no significant gender differences observed. High-fat meals delayed peak concentration but did not significantly affect overall exposure [4]. Efficacy Indicators - Pharmacodynamic analysis revealed that IFN-γ levels decreased with increased drug exposure, suggesting potential therapeutic effects for moderate to severe psoriasis. The exposure-effect curve indicated a plateau effect at doses of 16mg QD and above [4][5]. - The current dosing regimen shows good safety and pharmacokinetic characteristics, supporting further exploratory clinical studies in patient populations [5].