KELUN PHARMA(SZ:002422) Ge Long Hui A P P·2025-10-12 08:37Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the third indication of the antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1][2] Group 1 - The approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study aims to evaluate the efficacy and safety of sac-TMT administered as a monotherapy compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who progressed after EGFR-TKI and platinum-based chemotherapy [2] - The monotherapy with sac-TMT significantly extended the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]