drugset / Press release

VOLUNTARY ANNOUNCEMENT - MARKETING AUTHORISATION APPLICATION FOR AMPHOTERICIN B LIPOSOMAL, POWDER FOR CONCENTRATE FOR DISPERSION FOR INFUSION (HC1507G2) APPROVED IN EUROPE

2026-04-29 · 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 MARKETING AUTHORISATION APPLICATION FOR AMPHOTERICIN B LIPOSOMAL, POWDER FOR CONCENTRATE FOR DISPERSION FOR INFUSION (HC1507G2) APPROVED IN EUROPE The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that Amphotericin B Liposomal, Powder for Concentrate for Dispersion for Infusion (HC1507 G2) (the ‘‘Product ’’), independently developed by the Group, has received approval of the marketi ng authorisation application in the European Union. The approval of the Product marks a historic breakthrough as the first-ever Chinese liposomal formulation to be marketed in Europe, successful ly taking a crucial step forward in the global expansion of high-end pharmaceutical formulations . The approved indications cover clinical treatment of sever e systemic and/or deep fungal infections affecting one or more of the body ’s internal organs, and empirical treatment of presumed fung al infections in febrile neutropenic patients, where the feve r has failed to respond to broad-spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause. Amphotericin B is a macrocyclic, polyene antifungal antibiotic that exer ts its antifungal effects by binding to sterols in the fungal cell membranes, with a resulting change in memb rane permeability. The Product is a liposomal formulation. The liposome provides a unique deli very system for Amphotericin B, enabling it to preferentially accumulate at the site of infection and ma intaining potent antifungal activity, while reducing drug exposure in healthy tissues such as the kidney s, significantly lowering the risk of nephrotoxicity and infusion-related reactions, improvin g safety and enhancing the therapeutic index. The successful approval of the Product further enriches the Group ’s international product pipeline in the anti-infection field and fully demonstrates the Group ’s comprehensive capabilities in the research and development, large-scale production, quality managem ent and regulatory affairs of high-end complex injections. It effectively enhances the Group ’s competitiveness in the global high-end formulation market. Meanwhile, the Group will provide safe r and more effective treatment option for a broader population of patients with fungal infections. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 29 April 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, 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.

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