drugset / Press release

VOLUNTARY ANNOUNCEMENT - SYS6010 WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA

2025-01-02 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

Hong Kong Exchanges and Clearing Limited and The Stock Excha nge 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 whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT SYS6010 WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CH INA The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that SYS6010 (the Humanized Anti-human EGFR Monoclonal Antibody-JS-1 Conjugate Injec tion) (the ‘‘Product ’’) developed by CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of the Company, has been granted Breakthrough Therapy Designation by the National Medical P roducts Administration (NMPA) of the People ’s Republic of China for the intended indication of monothera py for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) after failure o f EGFR TKIs and platinum-based chemotherapy (the ‘‘Indication ’’). Lung cancer is the most common malignant tumor with the highe st incidence rate and mortality rate in China and worldwide, posing a serious threat to human health . Lung cancer patients are often diagnosed at a late stage, with a 5-year survival rate of arou nd 20% for stage III patients, and a 5-year survival rate of less than 5% and a median survival time of 7 mo nths for stage IV patients. Asian and Chinese NSCLC patients have an EGFR gene mutation r ate of 40 –50%. The relation between the efficacy of targeted-therapy and molecular subtypes in EGFR mutation-positive advanced NSCLC has been confirmed in clinical practice. EGFR-TKI has becom e the standard first-line treatment for EGFR mutation-positive advanced NSCLC. After failure of TK I treatment, the standard treatment is platinum-based chemotherapy+/-bevacizumab. However, fo r EGFR mutation-positive NSCLC patients who have failed TKIs and chemotherapy, the overall prognosi s is poor, thus there is an unmet clinical need for these patients. Currently, the development of the Product in various solid t umors is underway. The existing clinical data has confirmed that the efficacy of the Product as a singl e agent for the Indication is significantly better than the standard treatment. The Breakthrough Thera py Designation granted to the Product will further facilitate communication with the regulatory agen cy and expedite the development progress. – 1 – By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 2 January 2025 As at the date of this announcement, the Board comprises Mr. C AI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chu nlei, Dr. YAO Bing, Mr. CAI Xin and Mr. CHEN Weiping as executive directors; and M r. 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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