VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF SYHX2011 FOR THE TREATMENT OF ADVANCED BREAST CANCER

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 ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF SYHX2011 FOR THE TREATMENT OF ADVANCED BREAST CANCER 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 application for marketing approval of SYHX2011 (the ‘ ‘Product’ ’) developed by CSPC Ouyi Pharmaceutical Co., Ltd. ( 石藥集團歐意藥業有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Adm inistration of the People ’s Republic of China. Breast cancer is a common malignant tumor among women. Taxan es are the most effective cytotoxic chemotherapy drugs for advanced breast cancer, and have bee n shown to have greater survival benefits than other types of chemotherapy drugs, whether used alone o r in combination therapy. The Product is an innovative nano-formulation developed using patented t echnology based on Abraxane ® (paclitaxel for injection (albumin-bound)), with independent intelle ctual property rights. The Product was applied as a Class 2.2 chemical drug indicated for the treatment of me tastatic breast cancer after failure of combination chemotherapy or breast cancer recurrence with in 6 months after adjuvant chemotherapy (prior chemotherapy should have included an anthracycline anticancer drug unless clinically contraindicated). This application is primarily based on a multicenter, rando mised, double-blind pivotal Phase III clinical trial, with the study population consisting of breast cance r patients who are assessed by investigators to be suitable for single-agent antineoplastic therapy with p aclitaxel for injection (albumin-bound) in accordance with the China Society of Clinical Oncology (CSC O) Guidelines for Diagnosis and Treatment of Breast Cancer 2022. The clinical trial results demonstrated that the Product had significant therapeutic benefits over paclitaxel for inje ction (albumin-bound) in patients with advanced breast cancer: the intergroup ratios of the objective respo nse rate assessed by the Independent Review Committee (IRC) and the investigators were 1.38 (95% CI: 1.0 40, 1.842) and 1.33 (95% CI: 1.020, 1.745) respectively, both meeting the criteria for superio rity; the risk of disease progression or death was reduced by 27% (hazard ratio (HR) = 0.73 for progression- free survival (PFS)); and the risk of death was reduced by 33% (HR = 0.67 for overall survival (OS)) . In terms of safety, the risk of rash – 1 – with the Product decreased by 62%, indicating that the Produ ct was safer in clinical use, which assisted patients in improving their quality of life during treatmen t and also enhanced patients ’ adherence to treatment; and, in terms of clinical application, its signi ficantly shortened dispensing time resolved the issues of complex dispensing process and long reconstituti on time prior to the use of paclitaxel for injection (albumin-bound), thereby markedly improving th e convenience of clinical use. Leveraging its advantages in efficacy, safety and adherenc e, the Product is expected to become a new option for the treatment of advanced breast cancer. Concurr ently, the Group is also moving forward in clinical trials for other indications of the Product in orde r to bring benefit to more patients. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 9 December 2024 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 Chu nlei, Dr. YAO Bing, Mr. CAI Xin and Mr. CHEN Weiping as executive directors; and Mr. WANG 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 –

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