VOLUNTARY ANNOUNCEMENT - FIRST-IN-CLASS PRODUCT CANDIDATE ALMB-0168 GRANTED RARE PEDIATRIC DISEASE DESIGNATION BY THE U.S. FDA
2019-10-18 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
— 1 — 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. CSPC PHARMACEUTICAL GROUP LIMITED ʮ̡ (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) VOLUNTARY ANNOUNCEMENT FIRST-IN-CLASS PRODUCT CANDIDATE ALMB-0168 GRANTED RARE PEDIATRIC DISEASE DESIGNATION BY THE U.S. FDA 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 ind ependently developed by AlaMab Therapeutics Inc. (“ AlaMab ”), a subsidiary of the Company, was granted rare pediatric dis ease 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 o r 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-in- class humanized monoclonal antibody agonist for hemichannel Cx4 3 membrane protein. Through the activation of Cx43 protein to release tumor-inhibiting cyto kines, ALMB-0168 has shown to effectively inhibit osteosarcoma and bone metastasis in pre-cli nical 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 osteos arcoma will qualify for priority review. The U.S. FDA may also award a transferrable priority re view 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 201 9. — 2 — AlaMab is an innovative biopharmaceutical company in the U.S. d edicated to the research and development of first-in-class antibody drugs. Another product c andidate of its own for the same target (ALMB-0166) has also been granted orphan-drug designatio n 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 Chairman Hong Kong, 18 October 2019 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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