drugset / Press release

VOLUNTARY ANNOUNCEMENT - BIVALENT HPV mRNA THERAPEUTIC VACCINE (SYS6026) OBTAINS CLINICAL TRIAL APPROVAL

2024-11-12 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

Hong Kong Exchanges and Clearing Limited and The Stock Excha nge of Hong Kong Limited take no responsibility for the contents of this announcemen t, make no representation as to its accuracy or completeness and expressly disclaim any lia bility whatsoever for any loss howsoever arising from or in reliance upon the whole or any pa rt of the contents of this announcement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT BIVALENT HPV mRNA THERAPEUTIC VACCINE (SYS6026) 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 SYS6026, a therapeutic bivalent messenger RNA (mRNA) vacci ne against relevant precancerous lesions caused by human papillomavirus (HPV) type 16 or 18 (the ‘‘Product ’’) developed by the Group, has obtained approval granted by th e National Medical Products Administration (NMPA) of the People ’s Republic of China to conduct clinical trials in China. The Product is the first therapeutic vaccine independently developed by the Group based on its mRNA platform, consisting of mRNA molecules combined wi th a lipid nanoparticle (LNP) delivery system. The Product expresses the mRNA-enco ded E6 and E7 antigens of HPV type 16 or 18, generating antigen-specific T cells that c ould eliminate HPV-infected cells and inhibit tumorigenesis. Currently, clinical trea tments primarily rely on surgery, which have drawbacks of severe patient harm and relapse tend ency. As a highly effective non-surgical treatment option, the Product is expected to a ddress significant clinical needs within this field, providing a promising clinical developm ent value. Until now, there is no HPV therapeutic vaccine available on the market worldwide. The indication for this clinical trial approval is the treat ment of high-grade squamous intraepithelial lesion (HSIL) associated with HPV type 16 o r 18. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 12 November 2024 – 1 – As at the date of this announcement, the Board comprises Mr. C AI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. JIANG Hao, Dr. YAO Bing and Mr. CAI Xin as executive directors ; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. L AW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors. – 2 –

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