drugset / Press release

VOLUNTARY ANNOUNCEMENT - ALMB-0166 FOR TREATMENT OF ACUTE ISCHEMIC STROKE OBTAINS CLINICAL TRIAL APPROVAL IN CHINA

2023-11-17 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

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. (Incorpor ated in H ong Kong with limi ted liabi lity) (Stock co de: 1093) VOLUNTARY ANNOUNCEMENT ALMB-0166 FOR TREATMENT OF ACUTE ISCHEMIC STROKE OBTAINS CLINICAL TRIAL APPROVAL IN CHINA The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with itssubsidiaries, the“Group”) ispleased toannounce that theGroup’s ALMB-0166 has obtained approval granted by the National Medical Products Administration (NMPA) of the People’s Republic of China toconduct Phase II clinical trial evaluating its efficacy and safety inpatients with acute ischemic stroke in China. ALMB-0166 is a first-in-class humanized monoclonal antibody antagonist for the novel target hemichannel membrane protein Connexin 43 (Cx43), which is independently developed by AlaMab Therapeutics Inc., a subsidiary of the Company, for the treatment of neurological diseases including acute ischemic stroke and acute spinal cord injury. The treatment of acute ischemic stroke is focused on restoring blood circulation as soon as possible to minimize ischemia-induced nerve cell damage. Neuroprotective therapy can improve the prognosis of stroke patients and is expected to reduce the inflammatory response to injury and promote neurological recovery. ALMB-0166 can inhibit the release andspread ofneuro-inflammatory factors bytargeting Cx43hemichannels, thereby effectively providing neuroprotection. Preclinical trials showed that ALMB-0166 could significantly reduce the infarct volume in animals with ischemic stroke, and significantly restore their behavioral ability and function, while demonstrating a good dose-response relationship. ALMB-0166 for the treatment of acute spinal cord injury has also been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) in 2018. A Phase I clinical trial in healthy subjects has been completed in Australia and a Phase I/II clinical trial is ongoing in China. TheGroupwillendeavor toadvance theclinical development ofALMB-0166 fordifferent indications and launch the product as soon as possible. - 1 - By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 17 November 2023 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. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors. - 2 -

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