SUBMISSION OF CLINICAL TRIAL APPLICATION FOR INVESTIGATIONAL FIRST-IN-CLASS NEW DRUG ALMB-0168 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)

Hong Kong 27 November 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. (“AlaMab”), 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, humanized monoclonal antibody agonist for hemichannel connexin 43 (Cx43) (ALMB-0168). ALMB-0168 is a first-in-class humanized monoclonal antibody agonist for a novel target hemichannel Cx43 membrane protein, which is independently developed by AlaMab for the treatment of serious diseases with unmet medical needs, including bone cancer, bone metastases and osteoporosis.

ALMB-0168 has been granted orphan-drug designation and rare pediatric disease designation by the U.S. FDA in 2019 for the treatment of bone cancer. The successful submission of clinical trial application for ALMB-0168 in Australia was based on the results from in vitro and in vivo pharmacology and efficacy studies, as well as the safety profile demonstrated in pre-clinical toxicology studies. AlaMab also plans to initiate clinical trials for this innovative 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, Prof. 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.