VOLUNTARY ANNOUNCEMENT - PALBOCICLIB TABLETS OBTAINS DRUG REGISTRATION APPROVAL
2024-06-28 · 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 PALBOCICLIB TABLETS 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 the Palbociclib Tablets (125mg) (the “Product”), developed by the Group, has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China, and is deemed to have passed the consistency evaluation of quality and efficacy of generic drugs. Palbociclib is a cyclin-dependent kinases (CDK) 4 and 6 inhibitor that reduces cell proliferation in estrogen receptor (ER)-positive breast cancer cell lines by arresting cell progression from the G1 phase to the S phase. The Product is indicated for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, and is used in combination with an aromatase inhibitor as initial endocrine therapy for postmenopausal women. Compared to palbociclib capsules, the Product does not need to be taken with food and can eliminate drug interactions with proton pump inhibitors. The approval of the Product will further enrich the Group’s oncology product portfolio. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 28 June 2024 - 1 - 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. 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. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors. - 2 -
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