CSPC PHARMA (01093.HK): SYS6010 meets primary endpoint in Phase III study for EGFR-mutant NSCLC after EGFR TKI failure

NewTimeSpace News: On 26 August 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) announced that SYS6010 has successfully met the pre-specified primary endpoint of progression-free survival (PFS) in the Phase III clinical study (SYNSTAR-01) evaluating the product as monotherapy versus platinum-based chemotherapy in patients with EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed EGFR tyrosine kinase inhibitor (TKI) therapy, as assessed and reviewed by the independent data monitoring committee (IDMC). The study data showed that the product's PFS was significantly superior to the existing treatment regimen, with statistically significant and clinically meaningful differences in efficacy, and the product demonstrated a favorable overall safety profile.

The announcement stated that SYS6010 is an antibody-drug conjugate (ADC) targeting EGFR developed by the Group, comprising a humanized anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker. The product can specifically bind to EGFR receptors on the surface of tumor cells and release the cytotoxic payload intracellularly after internalization, thereby exerting anti-tumor pharmacological effects. Lung cancer ranks first in both incidence and mortality among malignant tumors in mainland China, with approximately 1.176 million new cases in 2024, NSCLC accounting for approximately 85% of lung cancer cases and EGFR-mutant patients accounting for approximately 40% to 50%; EGFR TKI is currently the first-line standard treatment for patients with EGFR-mutant advanced NSCLC, but patients inevitably develop resistance after treatment, and post-resistance treatment options are of limited efficacy — if the product is successfully approved and launched, it will provide patients with a new treatment option with high clinical application value and commercialization prospects.

SYNSTAR-01 is a randomized, open-label, multi-center Phase III clinical study designed to evaluate the efficacy and safety of the product versus platinum-based chemotherapy, with the primary endpoint of PFS assessed by an independent review committee (IRC). The study has now successfully met its pre-specified primary endpoint with positive results: in the pre-specified interim analysis, the product achieved a statistically significant and clinically meaningful improvement in PFS versus platinum-based chemotherapy, with an observed trend of benefit in overall survival (OS).

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.