drugset / Press release

VOLUNTARY ANNOUNCEMENT - ANTI-TUMOR NANODRUG "CISPLATIN MICELLE INJECTION" OBTAINS CLINICAL TRIAL APPROVAL

2022-04-20 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

– 1 – Hong Kong Exchanges and Clearing Limited and The Stock Exchange 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 whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. CSPC PHARMACEUTICAL GROU P LIMITED ͩᖹණྠ Ϟʮ̡ (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT ANTI-TUMOR NANODRUG “CISPLATIN MICELLE INJECTION” OBTAINS CLINICAL TRIAL APPROV AL 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 “Cisplatin Micelle Injection” (the “ Product”) developed by CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.* €ͩᖹණྠʕփႡᖹ ʮ̡, a subsidiary of the Company, has obtained clinical trial approval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. Cisplatin is a first-line drug for the treatment of several solid tumors, but its clinical application is limited by its severe adverse effects such as nephrotoxicity and neurotoxicity. The Group independently developed the Product using block copolymer as a carrier to achieve several unique advantages, including: (i) high drug loading capacity of cisplatin; (ii) lower toxic side effects by reduced accumulation of drugs in normal tissues; and (iii) preferential tumor accumulation attributable to the nanoscale size of cisplatin micelle, which is favourable for enhancing the therapeutic index. The preclinical studies demonstrated that compared with the conventional cisplatin preparation, the Product exhibited prolonged blood circulation time due to the existence in micelle form after administration; the toxic effects in rats and beagles significantly decreased with the same dose level, while the ototoxicity and neurotoxicity significantly reduced with the same or even higher dose level, thus significantly improving the safety window. At the same time, good anti-tumor effect was seen in several animal models of solid tumors. – 2 – The clinical indication of this approval is for the treatment of advanced malignant solid tumors. Based on the preclinical study results, the Product provides a promising prospect of demonstrating good efficacy in clinical trials. The Product is a Class 2 chemical drug in China and currently there is no product of the same type available in the global market. The Group will endeavor to push forward the clinical trials of the Product and strive to launch the Product as soon as possible. By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 20 April 2022 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. P AN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors. * For identification purposes only

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