VOLUNTARY ANNOUNCEMENT - IRINOTECAN HYDROCHLORIDE LIPOSOME INJECTION OBTAINS DRUG REGISTRATION APPROVAL
2023-09-15 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
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. (Incorpor ated in H ong Kong with limi ted liabi lity) (Stock co de: 1093) VOLUNTARY ANNOUNCEMENT IRINOTECAN HYDROCHLORIDE LIPOSOME INJECTION OBTAINS DRUG REGISTRATION APPROVAL The board of directors (the “Board”) of the CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Irinotecan Hydrochloride Liposome Injection (10ml:43mg) (the “Product”) developed by CSPC Ouyi Pharmaceutical Co., Ltd.* (石藥集團歐意藥業有限公司), a subsidiary of the Group, has obtained drug registration approval granted bytheNational Medical Products Administration ofthePeople’s Republic ofChina. The Product is approved, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic pancreatic cancer after disease progression following gemcitabine-based therapy. The therapy has shown significant survival benefits in Asian population. It was modified to Grade I recommendation (Level 1A evidence) in the Chinese Society ofClinical Oncology (CSCO) Guidelines in2020, which isthetherapy with thehighest level of recommendation and evidence among current second-line therapies for pancreatic cancer. The Product employs a new drug loading technology, which is superior to the traditional ammonium sulfate gradient method with ahigher drug loading capacity. The Group has independently developed the key excipients required for the new drug loading technology, solving the excipients sourcing problem and achieving lower production cost, and thus enhancing the competitive advantage. - 1 - The approval of the Product represents the addition of another heavyweight product to the Group’s portfolio for oncology diseases and further enriches the Group’s portfolio of high-end products. It also provides an additional treatment option for patients with advanced pancreatic cancer, improves drug accessibility and benefits more patients. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 15 September 2023 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, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive Directors. * For identification purposes only - 2 -
The release as fetched from its publisher. irasia.com ↗