ALMB-0166 was granted Orphan-Drug Designation by the U.S. FDA

 
CSPC Pharmaceutical Group Limited

石 藥 集 團 有 限 公 司

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

November 26, 2018

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 Group’s product candidate “humanized connexin 43 monoclonal antibody (ALMB-0166)” was granted orphan-drug designation by the U.S. Food and Drug Administration (the “U.S. FDA”) for the treatment of acute spinal cord injury (“SCI”).

SCI is a sudden traumatic injury that can result in a bruise, a partial injury or a complete injury to the spinal cord. It is a common cause of permanent disability and death in children and adults. Through its novel pathway of hemichannel inhibition, ALMB-0166 has been demonstrated efficacious in pre-clinical studies to prevent post-injury glial scar formation and result in functional recovery.

This orphan-drug designation will allow the Group to communicate with the U.S. FDA frequently and speed up the clinical development, registration and launch of ALMB-0166. The Group expects to file U.S. IND for ALMB-0166 in the fourth quarter of 2019.

ALMB-0166 is an antibody drug being developed by Alamab Therapeutics, Inc., a subsidiary of the Group in the U.S. focusing on the development of first-in-class antibody drugs.

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

Hong Kong, 26 November 2018 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Mr. LU Hua, Dr. LI Chunlei, Mr. ZHANG Cuilong, Dr. WANG Qingxi and Mr. CHAK Kin Man as executive directors; Mr. LEE Ka Sze, Carmelo as nonexecutive director; and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Professor LO Yuk Lam, Mr. YU Jinming and Mr. CHEN Chuan as independent non-executive directors.