drugset / Press release

VOLUNTARY ANNOUNCEMENT - PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION, RAPID SUSPENSION (ALBUMIN-BOUND) (SYHX2011G1) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2026-03-02 · 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 PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPEN SION, RAPID SUSPENSION (ALBUMIN-BOUND) (SYHX2011G1) OBTAINS CL INICAL TRIAL APPROVAL IN THE U.S. 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 Paclitaxel Protein-Bound Particles for Injectable Suspension, Rapid Suspension (Al bumin-Bound) (SYHX2011G1) (the ‘‘Product ’’) developed by the Group has obtained approval from the U.S. F ood and Drug Administration (FDA) to conduct clinical trials in the U.S. Breast cancer is the most common malignant tumor among women globally, posing a serious threat to women ’s health. Taxanes are the most commonly used and effective cy totoxic chemotherapeutic agents for the treatment of advanced breast cancer. They have been p roven to offer more significant survival benefits compared to other types of chemotherapy drugs, whe ther used as monotherapy or in combination therapy. The Product is a new generation innova tive nano-preparation developed using patented technology and has the potential to become the worl d’s first rapidly dissolving albumin-bound paclitaxel formulation. The indication for this approved clinical trial is the treat ment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adju vant chemotherapy. This clinical trial approval will further enrich the Group ’s international product pipeline and enhance the Group ’s international competitiveness. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 2 March 2026 – 1 – 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, Mr. QU Zhiyong and Mr. ZHANG Yiw ei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Dir ectors. – 2 –

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