drugset / Press release

VOLUNTARY ANNOUNCEMENT - NBL-028 FOR THE TREATMENT OF CLDN6 EXPRESSING ADVANCED TUMORS OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2023-08-17 · 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 NBL-028 FOR THE TREATMENT OF CLDN6 EXPRESSING ADVANCED TUMORS OBTAINS CLINICAL TRIAL APPROVAL 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-028, a CLDN6-CD137 bispecific 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) toconduct clinical trial for the treatment of CLDN6-expressing advanced tumors, including but not limited to testicular cancer, ovarian cancer, non-small cell lung cancer (NSCLC) and endometrial cancer in the U.S.. Claudin 6 is a member of the claudin family of tight junction (TJ) proteins and is expressed at high levels in multiple human malignancies but has little to no expression in normal tissues. CD137, or 4- 1BB, a member of the superfamily of tumor necrosis factor receptors (TNFR), is an inducible co- stimulatory receptor that plays a key role in T cell proliferation, survival, cytolytic activity, memory formation and other immune cell function modulations. NBL-028, targeting both human CLDN6 and human CD137, is designed to selectively activate the CD137 co-stimulatory pathway in T cells and other immune cells upon binding to the tumor cell surface CLDN6 in TME, resulting in conditional redirected tumor cell killing. NBL-028 has demonstrated superior efficacy and safety in preclinical studies. - 1 - NBL-028 is the first program entering clinical phase from Novarock’s proprietary T cell engager platform NovaTE. NovaTE is a next generation T cell co-stimulatory platform for treating cancer, especially solid tumors. NovaTE is designed and optimized to induce sustainable T effector cell activation, lift immune suppression in TME, while minimizing the risk of systemic toxicity including CRS, ICANS and hepatotoxicity. NBL-028 offers a potential therapeutic advantage in the efficacy and safety for patients with CLDN6-expressing tumors. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 17 August 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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