SUBMISSION OF CLINICAL TRIAL APPLICATION FOR INVESTIGATIONAL FIRST-IN-CLASS NEW DRUG ALMB-0166 IN AUSTRALIA

 
CSPC Pharmaceutical Group Limited

石 藥 集 團 有 限 公 司

(Incorporated in Hong Kong under the Companies Ordinance)
(Stock Code: 1093)

August 15, 2019

The Board of Directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that AlaMab Therapeutics Inc., a subsidiary of the Company, has submitted a clinical trial application to the relevant Ethics Committee in Australia for the first-in-human study for its investigational new drug, anti-connexin 43 (Cx43) humanized monoclonal antibody (ALMB-0166).

ALMB-0166 is a First-in-Class humanized antibody against a novel target hemichannel composed of Cx43 membrane protein. As an inhibitor of Cx43, ALMB-0166 is independently developed by the Group for the treatment of acute spinal cord injury and ischemic stroke as well as other neurological diseases with unmet medical needs. ALMB-0166 was granted Orphan Drug Designation by the U.S. FDA in 2018 for the treatment of acute spinal cord injury. The clinical trial application of this biological drug candidate was based on the promising results from in vitro pharmacology and in vivo efficacy studies in animal disease models as well as the safety profile demonstrated in pre-clinical toxicology studies. Initiation of the first-in-human study for ALMB-0166 in Australia is a major milestone for AlaMab Therapeutics Inc. on becoming a clinical stage biopharmaceutical company. The Group also plans to initiate clinical trials for this biological drug candidate in China, the U.S. and other countries.

By Order of the Board
CSPC Pharmaceutical Group Limited
CAI Dongchen
Chairman

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. LU Hua, Dr. LI Chunlei, Dr. WANG Qingxi 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, Professor LO Yuk Lam, Dr. YU Jinming and Mr. CHEN Chuan as independent non-executive directors.

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.