VOLUNTARY ANNOUNCEMENT - THE GROUP'S "HA121-28" AND "ALPROSTADIL LIPOSOME INJECTION" WERE GRANTED CLINICAL TRIAL APPROVALS
2017-11-06 · 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 ʮ ̡ (Incorporated in Hong Kong under the Companies Ordinance) (Stock Code: 1093) VOLUNTARY ANNOUNCEMENT THE GROUP’S “HA121-28”AND “ALPROSTADIL LIPOSOME INJECTION” WERE GRANTED CLINICAL TRIAL APPROVALS 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 pre-clinical trial data of the Class 1.1 chemical drug “ HA121-28 ” and Class 2.2 chemical drug “ alprostadil liposome injection” being developed by the Group has passed the technical assessment of the Center for Drug Evaluation of China Food and Drug Administration (the “ CFDA”) of the People’s Republic of China (“China ”), and were recently granted clinical trial approvals by the CFDA. HA121-28 is a Class 1 innovative drug developed by the Group as a new multi-target tyrosine kinase inhibitor that can inhibits EGFR, VEGFR and RET and its signal transmission within the cell. In the animal test, the drug showed positive therapeutic effect for esophageal, thyroid and gastric cancers. It is intended to be used for the treatment of gastrointestinal tumors, such as esophageal and gastric cancers. The novel molecular structure of HA121-28 has complete intellectual property rights. The Group has applied Patent Cooperation Treaty (PCT) patent for the chemical compound of the drug in 8 countries and regions, namely the U.S., the European Union, Japan, Korea, Russia, Canada, Australia and China. — 2 — Clinically, alprostadil is mainly used for the treatment of chronic arterial stenosis and the associated cold extremities, pain and ulceration. Compared with the regular injection formulation available in the market, the alprostadil liposome injection developed by the Group has distinct advantages in terms of its efficacy, stability and reduced side-effects. Up to now, the Group has obtained 6 clinical approvals during the year, including baicalein tablet (phase II clinical trial for Class 1 traditional Chinese medicine), amphotericin b cholesteryl sulfate complex for injection, simethicone soft capsule, irinotecan hydrochloride liposome injection (the U.S.), HA121-28 and alprostadil liposome injection. The Group will endeavor to complete the above clinical trials and launch the drugs as soon as possible. By Order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 6 November 2017 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. PAN Weidong, Mr. WANG Huaiyu, Mr. LU Jianmin, Mr. WANG Jinxu, Mr. WANG Zhenguo, Mr. LU Hua and Mr. CHAK Kin Man as executive directors; Mr. LEE Ka Sze, Carmelo as non-executive director; and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Mr. LO Yuk Lam, Mr. YU Jinming and Mr. CHEN Chuan as independent non-executive directors.
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