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, 18 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 humanized connexin 43 (Cx43) monoclonal antibody (ALMB-0168), a product candidate independently developed by AlaMab Therapeutics Inc. (“AlaMab”), a subsidiary of the Company, was granted rare pediatric disease designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. It represents another designation of ALMB-0168 in addition to the orphan-drug designation granted by the U.S. FDA in September 2019.

Osteosarcoma is a type of malignant tumor arising in human bone tissues, occurring most often in children and adolescents and usually leading to amputation or death. Currently there is limited medication or therapy for the treatment of osteosarcoma, though conventional chemotherapy and amputation are commonly used, presenting an unmet medical need. ALMB-0168 is a first-inclass humanized monoclonal antibody agonist for hemichannel 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 pre-clinical in vitro and in vivo animal studies.

According to the rare pediatric disease designation program of the U.S. FDA, the marketing application of ALMB-0168 for the indication of pediatric osteosarcoma will qualify for priority review. The U.S. FDA may also award a transferrable priority review voucher to AlaMab for the marketing application of a different product at the time of the marketing application approval of ALMB-0168 for the indication of pediatric osteosarcoma. AlaMab plans to file the clinical trial application of this drug candidate in the fourth quarter of 2019.

AlaMab is an innovative biopharmaceutical company in the U.S. dedicated to the research and development of first-in-class antibody drugs. Another product candidate of its own for the same target (ALMB-0166) has also been granted orphan-drug designation for the treatment of acute spinal cord injury by the U.S. 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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