Hengrui Pharmaceutical (600276.SH) Subsidiary Zhuoqibizumab Injection Application Accepted

Zhitong Finance App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. Recently, Guangdong Hengrui Pharmaceutical Co., Ltd., a subsidiary of the company, received the “Notice of Acceptance” issued by the State Drug Administration, and the company's drug marketing license application for Zhuoqibizumab injection (SHR-1819 injection) was accepted by the State Drug Administration. This drug is intended to treat severe atopic dermatitis in adults who are poorly controlled or unsuitable for topical treatment.

This listing is mainly based on a multicenter, randomized, double-blind, placebo-controlled phase III study of drotocibizumab injections in adults with severe atopic dermatitis. The main purpose of the study was to evaluate the efficacy and safety of drotocibizumab injections in patients with moderate to severe atopic dermatitis (AD) where topical medication is poorly controlled or unsuitable for external use. Professor Xu Jinhua of Huashan Hospital affiliated to Fudan University was the main researcher in the study. A total of 652 moderate to severe AD patients were enrolled nationwide. Research results showed that the drotocibizumab injection reached two common main efficacy endpoints, both were significantly superior to the placebo control group, and had good safety and tolerability.