Hengrui Medicine gets clinical trial nod for CSU drug HRS-3095

Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Drug Clinical Trial Approval" from the National Medical Products Administration for HRS-3095 tablets. This approval, granted on July 7, 2025, allows the company to initiate clinical trials for HRS-3095, a new small molecule compound targeting immune cells for chronic spontaneous urticaria (CSU) patients.

HRS-3095 tablets are an independently developed, small molecule compound that targets immune cells and has shown promising results in treating allergic diseases. Preclinical data indicates that HRS-3095 effectively improves skin allergy symptoms in mice. The company noted that there are currently no approved drugs with the same target for CSU globally. The cumulative research and development investment for the HRS-3095 project to date stands at approximately 16.03m yuan.

The company cautioned investors that drug development involves a lengthy and multi-stage process, from research and development to clinical trials and market approval, with inherent uncertainties. Jiangsu Hengrui Medicine will actively promote this R&D project and provide timely updates on its progress.