drugset / Press release

VOLUNTARY ANNOUNCEMENT - ANTI-TUMOR NANODRUG "SIROLIMUS FOR INJECTION (ALBUMIN-BOUND)" OBTAINS CLINICAL TRIAL APPROVAL

2021-06-09 · 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 GROUP LIMITED ʮ̡ (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT ANTI-TUMOR NANODRUG “SIROLIMUS FOR INJECTION (ALBUMIN-BOUND)” OBTAINS CLINICAL TRIAL 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 “Sirolimus for Injection (albumin-bound)” (the “Product”) developed by CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.*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, being the first sirolimus preparation administered by injection obtaining clinical trial approval in China. Sirolimus, also known as rapamycin, is a macrolide antibiotic immunosuppressant and a mTOR specific inhibitor. At present, sirolimus marketed in China and overseas are all oral medications for the prevention of organ rejection in patients receiving renal transplants. The Product utilises special technology to encapsulate sirolimus into human serum albumin to overcome the shortcoming that oral formulation fails to deliver sufficient concentration of drug to target site, thus having the potential for treating a series of diseases caused by the mTOR signaling pathway. The Product has achieved administration of sirolimus by injection without hormone pre- treatment and expanded the field of application of the drug. The clinical indication of this approval is for the treatment of solid tumors and hematological tumors. The preclinical study demonstrated that the Product has good anti-tumor activity in several models of solid tumors and hematological tumors, providing a promising prospect of demonstrating good anti-tumor efficacy in clinical trials. The Product is a Class 2 chemical drug under the registration system 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. — 2 — By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 9 June 2021 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN 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

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