CSPC PHARMA (01093.HK): SYS6010 Included in China's Breakthrough Therapy Designation List for Driver-Gene-Negative Non-Squamous NSCLC

NewTimeSpace News: On 15 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093.HK) announced on a voluntary basis that SYS6010, developed by the Group, has recently been included by the National Medical Products Administration (NMPA) of the PRC in the breakthrough therapy designation list, for the proposed indication of relapsed or metastatic driver-gene-negative non-squamous non-small cell lung cancer (NSCLC) in patients who have failed prior immunotherapy and platinum-containing chemotherapy. The product is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) developed by the Group, comprising a humanised anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor as the payload via a cleavable linker; it specifically binds to EGFR on the surface of tumour cells and, after internalisation, releases the cytotoxic payload intracellularly to exert its anti-tumour effect.

The announcement disclosed that, according to the Analysis of the Epidemic Situation of Malignant Tumours in Different Regions of China in 2024 published by the National Cancer Centre of China, there were approximately 1.176 million new lung cancer cases and approximately 743,000 deaths in China in 2024. NSCLC is the main pathological subtype of lung cancer, accounting for about 85% of all lung cancer cases, with driver-gene-negative patients accounting for about 40% and an incidence rate rising year by year. Immunotherapy combined with platinum-containing chemotherapy is the first-line standard treatment for driver-gene-negative NSCLC; after failure of first-line treatment, second-line standard treatment remains mainly single-agent chemotherapy, with unsatisfactory overall clinical efficacy and limited survival benefit. The product significantly improved the objective response rate in patients with driver-gene-negative non-squamous NSCLC and produced durable responses, with progression-free survival (PFS) more than doubled compared with standard treatment.

A randomised, open-label, multicentre Phase III clinical trial evaluating the product as monotherapy in driver-gene-negative locally advanced or metastatic non-squamous NSCLC that has failed standard treatment is currently underway. The product has previously been granted three breakthrough therapy designations by the NMPA, for monotherapy in EGFR mutation-positive advanced NSCLC that has failed EGFR-TKI and platinum-containing chemotherapy; unresectable locally advanced or metastatic oesophageal squamous cell carcinoma that has failed prior first-line platinum-containing chemotherapy and immune checkpoint inhibitor treatment; and relapsed or metastatic head and neck squamous cell carcinoma that has failed immunotherapy and platinum-containing chemotherapy.

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