drugset / Press release

VOLUNTARY ANNOUNCEMENT - NBL-020 FOR THE TREATMENT OF ADVANCED SOLID TUMORS OBTAINS CLINIAL TRIAL APPROVAL IN CHINA

2023-02-16 · 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 NBL-020 FOR THE TREATMENT OF ADVANCED SOLID TUMORS OBTAINS CLINIAL TRIAL APPROVAL IN CHINA The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that NBL-020, a fully human antibody drug independently developed by NovaRock Biotherapeutics Limited (“NovaRock”), a subsidiary of the Company in the United States, has obtained approval granted by the China National Medical Products Administration of the People’s Republic of China to conduct clinical trials for the treatment of advanced solid tumors in China. NBL-020 is a fully human monoclonal antibody against tumor necrosis factor receptor 2 (TNFR2). TNFR2, belonging to the TNF receptor (TNFR) superfamily, promotes tumor progression directly or indirectly by maintaining an immune-suppressed microenvironment for tumor cells via various signaling pathways. It stimulates various immune suppressive cell types, including regulatory T-cells (Tregs) and myeloid-derived suppressor cells (MDSCs) and can act as an oncogene. Inhibition of highly suppressive Tregs and MDSCs using TNFR2 antibodies in tumor microenvironment is a promising novel strategy for the treatment of advanced solid tumors. NBL-020 is discovered and developed from NovaRock’s proprietary Affinity Function Integrated Screening (AFIS) technology platform. Preclinical studies have demonstrated that NBL-020 has an excellent safety profile, high affinity to target cells and potent anti-tumor activity. It is able to inhibit tumor growth and prolong survival as a single agent or in combination with anti-PD1 antibodies in both PD-1 sensitive and PD-1 resistant syngeneic animal models. Although PD-1/PD-L1 inhibitors have made remarkable breakthroughs in solid tumor treatment, there are still significant unmet medical needs for PD-1/PD-L1 resistant/refractory tumors. NBL-020 offers potential advantages to treat anti-PD-1/PD-L1 resistant and refractory patients. - 1 - NBL-020 has also obtained Investigational New Drug (IND) approval granted by the U.S. Food and Drug Administration in December 2022. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 16 February 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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