First-in-Class Product Candidate ALMB-0168
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)

Hong Kong, 23 September 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 humanized connexin 43 (Cx43) monoclonal antibody (ALMB-0168), a product candidate independently developed by AlaMab Therapeutics, Inc., a subsidiary of the Group, was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma.

Osteosarcoma is a type of malignant tumor occurring in bone tissues, usually leading to amputation or death. Currently there is limited medication or therapy for the treatment of osteosarcoma, though routine chemotherapy and amputation are commonly used, therefore presenting an unmet medical need. ALMB-0168 is a First-in-Class humanized antibody agonist for hemichannel connexin 43 (Cx43) membrane protein. Through the activation of Cx43 protein to release tumor-inhibiting cytokines, ALMB-0168 has shown to effectively inhibit osteosarcoma and bone metastasis in preclinical in vitro and in vivo animal models.

This orphan-drug designation will allow the Group to communicate with the FDA frequently and speed up the clinical development, registration and launch of ALMB-0168. The Group plans to file first-in-human clinical study application for ALMB-0168 in the fourth quarter of 2019.

Alamab Therapeutics, Inc. is an innovative biopharmaceutical company in the U.S. dedicated to the research and development of First-in-Class antibody drugs. Its another clinical stage antibody (ALMB-0166) antagonist for the same target was granted orphan drug designation for the treatment of acute spinal cord injury by the FDA in November 2018.

By Order of the Board
CSPC Pharmaceutical Group Limited
CAI Dongchen

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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