drugset / Press release

VOLUNTARY ANNOUNCEMENT - NBL-020 FOR THE TREATMENT OF ADVANCED SOLID TUMORS OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2022-12-22 · 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. (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT NBL-020 FOR THE TREATMENT OF ADV ANCED SOLID TUMORS OBTAINS CLINICAL TRIAL APPROV AL IN THE U.S. 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 the Company’s subsidiary NovaRock Biotherapeutics Limited (“NovaRock”), has obtained approval of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to conduct clinical trial for the treatment of advanced solid tumors in the U.S.. 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. While 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 a potential advantage in the treatment of cancers that are resistant and refractory to anti-PD-1/PD-L1 check point inhibitors. The Group will endeavor to advance the clinical development of NBL-020 and launch the product as soon as possible. – 2 – By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 22 December 2022 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. P AN 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.

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