drugset / Press release

VOLUNTARY ANNOUNCEMENT - SYS6055 INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA

2026-01-29 · 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 announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT SYS6055 INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that SYS6055 Injection (the ‘‘Product ’’) developed by the Group has obtained approval from the Natio nal Medical Products Administration of the People ’s Republic of China (NMPA) to conduct clinical trials in Chin a. The Product is the first in vivo CAR-T product approved for cl inical trials in China. By directly generating CAR-T cells targeting CD19 in vivo through lenti viral vectors, it can specifically recognize and eliminate target cells, thereby achieving therapeutic effect. Compared with traditional CAR-T products, the Product offers potential advantages in cost, accessibility and immediacy. Preclinical studies demonstrated that the Product could specifically g enerate CAR-T cells in vivo, exhibiting significant tumor inhibition effect and a favorable safety profile, as well as cost and time advantages. It is expected to provide a better treatment option for patient s with B-cell lymphoma. The indication for this clinical trial approval is relapsed /refractory aggressive B-cell lymphoma. In addition, the Product also has the potential to be used for th e treatment of other CD19-positive B-cell malignancies and autoimmune diseases, providing a promisi ng clinical development value. By order of the Board CSPC Pharmaceutical Group Limited Cai Dong Chen Chairman Hong Kong, 29 January 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. WANG Huaiy u, Dr. LI Chunlei, Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping and Mr. QU Zhiyong, as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Directors.

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