drugset / Press release

VOLUNTARY ANNOUNCEMENT - THE GROUP'S ONCOLOGY DRUG "SKLB1028 CAPSULES" WAS GRANTED CLINICAL TRIAL APPROVAL

2016-02-25 · 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 cont ents of this announcem ent, 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 w hole or any part of the contents of this announcement. VOLUNTARY ANNOUNCEMENT THE GROUP’S ONCOLOGY DRUG “SKLB1028 CAPSULES” WAS GRANTED CLINICAL TRIAL APPROVAL The board of directors (the “ Board”) of CSPC Pharmaceuti cal 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 “ SKLB1028 Capsules” (the “Product”) being developed by the Group has passed the tec hnical assessment of the Centre for Drug Evaluation of China Food and Drug Administration (the “ CFDA”) of the People’s Republic of China (“China”), and was recently granted clinical trial approval from the CFDA. SKLB1028 is a novel multi-target protein kinase inhibitor being developed by the Group in collaboration with Sichuan University. Its major molecular targets include FLT3, EGFR, Abl, Fyn, Hck, Lck, Lyn, Ret and Yes. Pharmacology e xperiments at pre-clinical trial indicated exceptional inhibiting activity and good tolerance in various tumor treatments such as leukemia, non-small cell lung cancer, and in particular, acute myeloid leukemia (“AML”) with FLT3-ITD mutation. The novel molecular structure of SKLB1028 has complete intellectual property rights. The Group has applied Patent Cooperation Treaty (PCT ) patent for the chemical compound of the Product in the U.S., European Union, Japan, Korea and China and authorization was already granted in China. AML patients commonly have multiple mutations or aberrant expression of genes including FLT3, Lyn, Lck and cSrc. Approximately 30% of the AML patients have FLT3 gene mutation and approximately 20% have FLT3 -ITD gene mutation. The prognosis of AML patients with FLT3-ITD mutation is in general poor with high rate of relapse. -2- Currently, there are several FLT3-ITD targeted small molecule drug s including quizartinib, midostaurin and lestaurtinib being develope d by other overseas pharmaceutical companies, but none of these drugs have been launched in the market yet. The Group will endeavor to launch the Product in order to benefit patients with tumor in China. By Order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 25 February 2016 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. CHAK Kin Man, Mr. P AN Weidong, Mr. WANG Shunlong, Mr. WANG Huaiyu, Mr. LU Jianmin, Mr. WANG Zhenguo, Mr. WANG Jinxu and Mr. LU Hua as executive directors; Mr. LEE Ka Sze, Carmelo as nonexecutive director; and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Mr. LO Yuk Lam and Mr. YU Jinming as independent non-executive directors.

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