drugset / Press release

VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION OF BATOCLIMAB (HBM9161) ACCEPTED BY THE NMPA

2023-06-29 · 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 BIOLOGIC LICENSE APPLICATION OF BATOCLIMAB (HBM9161) ACCEPTED BY THE NMPA 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 National Medical Products Administration (NMPA) of the People’s Republic of China has officially accepted the biologic license application of Batoclimab (HBM9161), an in-licensed product of CSPC NBP Pharmaceutical Co. Ltd* (石藥集團恩必普藥業有限公司) (“NBP”), a subsidiary of the Company, forthetreatment ofgeneralised myasthenia gravis (“gMG”). Batoclimab (HBM9161)isaproducttotreatmultiplepathogenic IgG-mediated autoimmune diseases withsignificant unmetmedical needs. gMGisamongthefirstofsuchmultiple indications andthis therapyreceivedtheBreakthroughTherapyCertificatefromtheNMPAinearly2021andreleasedthe positive topline dataofitsPhaseIIclinical trialinJuly2021.InOctober 2022,NBPentered intoa licenseagreementwithHarbourBiomed(Shanghai)Co.,Ltd.toobtainthedevelopment,manufacture and commercialization rights of Batoclimab (HBM9161) in Greater China. In March 2023, Batoclimab (HBM9161) for the treatment of gMG demonstrated positive topline results in its PhaseIIIclinicaltrial,meetingprimaryefficacyendpoint aswellaskeysecondary endpoints witha favourable safety profile. Basedonthecharacteristics ofBatoclimab’s mechanismofactionandtheclinicaldataavailable, the Group plans tocontinue itsdevelopment inother indications ofautoimmune diseases. -1- ByOrder oftheBoard CSPC Pharmaceutical Group Limited CAI Dongchen Chairman HongKong, 29June2023 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. * For identification purposes only -2-

The release as fetched from its publisher. irasia.com ↗