VOLUNTARY ANNOUNCEMENT - AMPHOTERICIN B LIPOSOME FOR INJECTION OBTAINS DRUG REGISTRATION APPROVAL
2024-09-16 · 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 announcemen t, make no representation as to its accuracy or completeness and expressly disclaim any lia bility whatsoever for any loss howsoever arising from or in reliance upon the whole or any pa rt of the contents of this announcement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT AMPHOTERICIN B LIPOSOME FOR INJECTION OBTAINS DRUG REGISTRATION 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 Amphotericin B Liposome for Injection (the ‘‘Product ’’) developed by the Group has obtained drug registration approval granted by the Nationa l Medical Products Administration of the People ’s Republic of China. The indications for this approval include: 1) treatment of s ystemic fungal infections caused by susceptible fungi; 2) treatment of patients with neutrop enia and unexplained fever who are highly suggestive of the presence of systemic fungal inf ections; and 3) treatment of visceral leishmaniasis in adults and children. Amphotericin B is a type of polyene antibiotics and is one of t he most potent and broad spectrum drugs for the prevention and treatment of invasive fungal diseases. It kills fungal cells by binding to ergosterol, a sterol component in the cel l membrane of susceptible fungi, to form transmembrane channels which lead to alterations in cell membrane permeability. The Product utilises a liposomal drug delivery system, enca psulating amphotericin B into small unilamellar liposomes of less than 100nm formed by hyd rogenated soybean phosphatidylcholine, distearoyl phosphatidylglycerol a nd cholesterol. Compared with other amphotericin B injections on the market, the Product mainly exists in the bloodstream in liposomal form, which can significantly reduce the binding of free amphotericin B to renal tubular epithelial cells, resulting in significant reduct ion of drug nephrotoxicity, decrease in infusion reactions, shortened administration duration, i ncrease in dosage and improvement of therapeutic index. – 1 – The approval of the Product marks significant progress of th e Group in the fields of nanomedicine research and development and antifungal infe ctions, and further enriches the Group ’s product portfolio in antifungal infections. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 16 September 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 Chunlei, Dr. JIANG Hao, Dr. YAO Bing and Mr. CAI Xin as executive directors ; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. L AW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors. – 2 –
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