VOLUNTARY ANNOUNCEMENT - DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) GRANTED ORPHAN-DRUG DESIGNATION BY U.S. FDA FOR TREATMENT OF GASTRIC CANCER
2022-07-28 · 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. (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) GRANTED ORPHAN-DRUG DESIGNATION BY U.S. FDA FOR TREATMENT OF GASTRIC CANCER The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that “Docetaxel for Injection (albumin-bound)” (the “Product”), a new drug developed by CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.*(ͩᖹණྠʕփႡᖹҦஔ()ʮ̡), a subsidiary of the Company, was granted orphan-drug designation by the U.S. Food and Drug Administration for the treatment of gastric cancer including cancer of gastroesophageal junction. The Product employs innovative human serum albumin encapsulation technology to deliver docetaxel in nanoparticles into patients. With this technology, the Product will eliminate the need for premedication with hormone as required for all currently marketed docetaxel products, and will have no infusion related hypersensitivity reactions. The Product can also significantly increase in vivo drug exposure and improve safety, efficacy and patient compliance. Existing clinical data showed that the maximum tolerated dose of the Product is 125 mg/m 2, which is higher than that of the conventional docetaxel injection (75 mg/m 2); the in vivo drug exposure under the proposed clinical dose is 2.8 times that of the conventional injection; the objective response rate (ORR) of second- line treatment of gastric cancer patients is 40%, which is 2 times that of the conventional injection. Since the Product does not require premedication with hormone, when used in combination with PD-1/PDL-1 antibodies, the efficacy of PD-1/PDL-1 antibodies will not be affected by the use of hormone. The Product has entered several pivotal clinical studies in China and Phase I study in the U.S.. Based on the advantages shown in clinical studies, the Product has the potential to replace the currently marketed docetaxel products to be the first-line drug. By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 28 July 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, Mr. LAW Cheuk Kin Stephen and Ms. WU Guizhen as independent non-executive directors. * For identification purposes only
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