drugset / Press release

VOLUNTARY ANNOUNCEMENT - COVID-19 mRNA VACCINE "SYS6006" OBTAINS CLINICAL TRIAL APPROVAL

2022-04-03 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

– 1 – 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. CSPC PHARMACEUTICAL GROU P LIMITED ͩᖹණྠ Ϟʮ̡ (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT COVID-19 mRNA V ACCINE “SYS6006” OBTAINS CLINICAL TRIAL APPROV AL The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) announces that the COVID-19 mRNA vaccine “SYS6006” (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. SYS6006 is a mRNA vaccine independently developed by the Group against SARS-CoV-2 virus mutant strains. Core mutations of prevalent variants have been specifically incorporated into antigen design during the development of the Product. Preclinical studies demonstrated the Product can generate high neutralizing activity against the prevalent variants (including Omicron and Delta strains), and is capable of providing protection through humoral and cellular immunity and inducing long-term memory B cells against SARS- CoV-2 virus. Preclinical studies also showed good safety profile of the product. The Product adopts highly controllable and reproducible processes to produce high-quality products with assured batch-to-batch consistency. This process is also highly scalable for commercial-scale manufacturing. The Product features a good stability property with long-term storage at 2-8℃. Key starting materials can be sourced from the Group’s own production and other domestic manufacturers to further mitigate costs and supply chain challenge. – 2 – With its advantages in terms of safety, efficacy and industrialization, and the need for epidemic prevention and control, the Product was granted quick approval for clinical trials by the National Medical Products Administration under special approval procedure. The Group will strive to push forward the domestic and international multi-center clinical studies of the Product, and launch the Product as soon as possible in order to overcome the global COVID-19 pandemic. By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 4 April 2022 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. P AN 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 and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.

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