drugset / Press release

VOLUNTARY ANNOUNCEMENT - SECUKINUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL

2023-11-01 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. (Incorpor ated in H ong Kong with limi ted liabi lity) (Stock co de: 1093) VOLUNTARY ANNOUNCEMENT SECUKINUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Secukinumab Injection (the “Product”) developed by the Group has obtained approval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. The Product is a fully human monoclonal antibody against human interleukin-17A (IL-17A), a biosimilar to Cosentyx. It is applied as a Class 3.3 therapeutic biological product for the indication of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Through pharmaceutical and non-clinical studies according to the relevant research guidelines for biosimilars, the Product has been scientifically and rigorously proven to be highly similar to the innovator drug in terms of quality, safety and efficacy, which supports follow-up clinical studies. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 1 November 2023 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors.

The release as fetched from its publisher. irasia.com ↗