VOLUNTARY ANNOUNCEMENT - NEW INDICATION FOR DUOENYI (IRINOTECAN HYDROCHLORIDE LIPOSOME INJECTION) OBTAINS MARKETING APPROVAL

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 NEW INDICATION FOR DUOENYI (IRINOTECAN HYDROCHLORIDE LIPOSOME INJECTION) OBTAINS MARKETING 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 new indication for the irinotecan hydrochloride liposome injection (brand name: Duoenyi) (the ‘‘Product ’’), developed by the Group has obtained marketing approval granted by the Nation al Medical Products Administration of the People ’s Republic of China. The newly approved indication is for use in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-li ne treatment of patients with metastatic pancreatic cancer (the ‘‘Indication ’’). The approval of the Indication is primarily based on a pivota l clinical study enrolling patients with histologically or cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer who had not received prior systemic anti-tumor therapy. Res ults disclosed at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting showed t hat the Product significantly prolonged progression-free survival (PFS) in first-line treatment f or advanced pancreatic cancer (hazard ratio (HR) of 0.55, representing a 45% reduction in the risk of disease p rogression or death), demonstrated a trend of benefit in objective response rate (ORR), duration of res ponse (DOR), and overall survival (OS), and had a good safety profile, achieving reduced toxicity and en hanced efficacy compared with conventional formulations. – 1 – The Product was first approved for marketing in China on 15 Se ptember 2023. Its initial approved indication was for use in combination with 5-fluorouracil ( 5-FU) and leucovorin (LV) for the treatment of patients with metastatic pancreatic cancer who had progr essed after receiving gemcitabine treatment, marking the first approval of an irinotecan hydrochloride l iposome injection developed by a domestic enterprise in China. The indication approved this time is th e Product ’s second approved indication in China and also the first approval of an irinotecan liposomal injection for first-line treatment of pancreatic cancer domestically. Currently, a pivotal regi stration Phase III clinical trial of the Product as adjuvant treatment after pancreatic cancer surgery is unde rway. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 12 December 2025 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. YAO Bin g, Mr. CAI Xin, Mr. CHEN Weiping and Mr. QU Zhiyong as Executive Directors; and Mr. WA NG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Steph en and Ms. LI Quan as Independent Non-executive Directors. – 2 –

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