drugset / Press release

VOLUNTARY ANNOUNCEMENT - BIVALENT COVID-19 mRNA VACCINE (SYS6006.32) OBTAINS CLINICAL TRIAL APPROVAL

2023-10-30 · 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 BIVALENT COVID-19 mRNA VACCINE (SYS6006.32) 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 bivalent COVID-19 mRNA vaccine (XBB.1.5/BQ.1 variants) (SYS6006.32) (the “Product”) developed by the Group has obtained clinical trial approval granted by the National Medical Products Administration of the People’s Republic of China. SYS6006.32 is a bivalent COVID-19 mRNA vaccine containing XBB.1.5 and BQ.1 variants developed by the Group on the basis of the first generation COVID-19 mRNA vaccine (brand name: Duentai (度恩泰)), whichhasbeenincluded foremergency useinChina. ItisthefirstmRNAvaccine which targets dominant variants represented by XBB.1.5 in China. Non-clinical study data demonstrated that the Product not only induced very high immunogenicity against the dominant variants EG.5 and XBB.1.5, with the levels of live virus neutralizing antibody 108 and 88 times of those induced by Duentai respectively, but also induced broad-spectrum cross-variant immunity against mutant strains including XBB.1.16, XBB.1.9, BA.5, BQ.1 and BA.2.86. The Product had a good safety profile, with no additional risks as compared to Duentai. With the advantages of the Group’s first generation COVID-19 vaccine in terms of safety, efficacy and industrialization, the Product was granted quick approval for clinical trials by the National Medical Products Administration under special approval procedures. The Group will expedite the promotion of emergency use of the Product. - 1 - By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 30 October 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. - 2 -

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