drugset / Press release

VOLUNTARY ANNOUNCEMENT - SYS6010 GRANTED BREAKTHROUGH THERAPY DESIGNATION BY NMPA IN CHINA FOR THE TREATMENT OF PATIENTS WITH ACTIONABLE GENOMIC ALTERATION-NEGATIVE NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

2026-09-15 · 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 GRANTED BREAKTHROUGH THERAPY DESIGNATION BY NMPA IN CHINA FOR THE TREATMENT OF PATIENTS WITH ACTIONABLE GENOMIC ALTERATION-NEGATIVE NON-SQUAMOUS NON-SMALL CELL LUNG CANCER 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 ‘‘Product ’’), developed by the Group, has recently been granted Breakthro ugh Therapy Designation by the National Medical Products Administration ( ‘‘NMPA ’’) of the People ’s Republic of China. The proposed indication is for recurrent or metastatic actionable genom ic alteration-negative non-squamous non-small cell lung cancer ( ‘‘NSCLC ’’) that has failed prior immunotherapy and platinum-based ch emotherapy. The Product is an antibody-drug conjugate (ADC) targeting t he epidermal growth factor receptor (‘‘EGFR ’’) developed by the Group, which is composed of a humanised ant i-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker. The Product specifically binds to EGFR on the surface of tumour cells and releases the cytotoxic payload intracellularly upon internalisation, thereby exerting a nti-tumour effects. Lung cancer is one of the leading causes of cancer incidence a nd mortality worldwide. According to the ‘‘2024 Analysis of Regional Cancer Incidence in China ’’ released by the National Cancer Center of China, approximately 1.176 million new lung cancer cases we re diagnosed in China in 2024, with approximately 743,000 associated deaths, representing th e highest incidence and mortality rates globally. NSCLC is the predominant pathological subtype of lung cancer, accounting for approximately 85% of all lung cancer cases. Among patients with NSCLC, thos e who are actionable genomic alteration-negative account for approximately 40%, and th e incidence rate within this patient population is increasing annually. Immunotherapy in combination with platinum-based chemotherapy is the standard first-line treatment regimen for actionable geno mic alteration-negative NSCLC. Following the – 1 – failure of first-line treatment, the standard second-line treatment still predominantly relies on single- agent chemotherapy, which exhibits suboptimal overall cli nical efficacy and provides limited survival benefits for patients. The Product significantly increased the objective respons e rate of patients with actionable genomic alteration-negative non-squamous NSCLC, and demonstrate d a durable response period. Its progression- free survival (PFS) was more than twice as long as that of stan dard treatment, indicating that patients treated with the Product derived substantial survival bene fits. Its clinical efficacy was significantly superior to that of existing standard treatments. The Produ ct has demonstrated outstanding clinical value. It is anticipated that upon marketing approval, it wi ll provide patients with enhanced treatment options and exhibit significant market potential. Current ly, a randomised, open-label, multicentre Phase III clinical trial is underway to evaluate the Product as a mo notherapy for the treatment of actionable genomic alteration-negative locally advanced or metastat ic non-squamous NSCLC that has failed standard treatment. Previously, the Product has been granted three Breakthroug h Therapy Designations by the NMPA for the following proposed indications: as a monotherapy for EG FR mutation-positive advanced non-small cell lung cancer (NSCLC) after failure of EGFR-TKIs and plat inum-based chemotherapy; unresectable locally advanced or metastatic esophageal squamous cell ca rcinoma (ESCC) in patients who have failed prior first-line treatment with platinum-based chemother apy and immune checkpoint inhibitors (ICIs); and recurrent or metastatic head and neck squamous cell carc inoma (R/M HNSCC) in patients who have failed prior immunotherapy and platinum-based chemot herapy. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 15 September 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei as Execut ive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Ala n, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Direct ors. – 2 –

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