INVESTIGATIONAL NEW DRUG ALMB-0166
GRANTED CLINICAL TRIAL APPROVAL IN AUSTRALIA
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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, 21 October 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 obtained approval from the relevant Ethics Committee and Clinical Trial Centre, and received the Acknowledgement of Clinical Trial Notification from the government regulatory body, Therapeutic Goods Administration, for conducting the first-in-human clinical trial of its investigational new drug, humanized Connexin 43 (Cx43) monoclonal antibody (ALMB-0166), for the treatment of acute spinal cord injury in Australia.
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 AlaMab 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. This clinical trial approval demonstrates the recognition from the regulatory body of the preclinical trial results and clinical trial feasibility of ALMB-0166 as a first-in-class new drug. AlaMab also plans to initiate relevant clinical trials for ALMB-0166 in China, the U.S. and other countries so as to expedite the R&D progress of this drug candidate.
AlaMab is an innovative biopharmaceutical company in the U.S. dedicated to the research and development of first-in-class antibody drugs.
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.
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