VOLUNTARY ANNOUNCEMENT - PACLITAXEL FOR INJECTION (ALBUMIN-BOUND) (II) RECEIVES MARKETING APPROVAL
2026-06-15 · 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 FOR INJECTION (ALBUMIN-BOUND) (II) RECEIVES 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 Paclitaxel for Injection (Albumin-Bound) (II) (100mg) (the ‘‘Product ’’) developed by the Group has received marketing approval from the National Medical Products Administratio n of the People ’s Republic of China, making it the global first quick-dissolving albumin-bound paclit axel formulation. The Product is an innovative anti-tumor nano-formulation i ndependently developed by the Group. It adopts an innovative formulation and preparation process, with related patents having been granted in major countries and regions including China, the United Sta tes and Europe. It is indicated for the treatment of metastatic breast cancer after failure of comb ination chemotherapy or breast cancer relapse within 6 months of adjuvant chemotherapy (prior chemothera py regimens should have included an anthracycline unless clinically contraindicated). The results of a multicenter, randomised, double-blind piv otal Phase III clinical study showed that the Product demonstrated more significant efficacy benefits i n patients with breast cancer compared with Paclitaxel for Injection (Albumin-Bound): the between-gr oup ratios of objective response rate as assessed by the Independent Review Committee (IRC) and inve stigators were 1.38 (95% CI: 1.040, 1.842) and 1.33 (95% CI: 1.020, 1.745), respectively, both m eeting the superiority criteria. The risk of disease progression or death was reduced by 27% (hazard rati o ( ‘‘HR’’) for progression-free survival (PFS) = 0.73); and the risk of death was reduced by 33% (HR for o verall survival (OS) = 0.67). Compared with the control drug, the Product reduced the risk of rash incidence by 62%, demonstrating a better safety profile in clinical use, which helps improve patients ’ quality of life and enhance medication adherence. At the same time, the reconstitution time was shortened by 82%, significantly improving convenience of clinical use. – 1 – The marketing approval of the Product could effectively add ress the clinical treatment shortcomings of existing taxane drugs, further enrich clinical medication regimens, provide higher-quality treatment options, and enhance the Group ’s competitiveness in the field of anti-tumor chemotherapy d rugs. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 15 June 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, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei 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. – 2 –
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