Kelun subsidiary's ADC gets third NMPA approval for lung cancer

Sichuan Kelun Pharmaceutical announced that its subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd., received National Medical Products Administration (NMPA) approval for a third indication for its TROP2 ADC, sac-TMT (SKB264/MK-2870). This approval covers adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations that have progressed after EGFR-TKI treatment. sac-TMT is highlighted as the first and only ADC globally to demonstrate significant overall survival (OS) benefit compared to platinum-based doublet chemotherapy in this patient population.

This approval is based on the Phase III OptiTROP-Lung04 clinical study, which will be presented as a breakthrough abstract at the 2025 European Society for Medical Oncology (ESMO) conference. The study evaluated sac-TMT monotherapy against pemetrexed combined with platinum-based chemotherapy, showing significant improvements in progression-free survival and overall survival.

sac-TMT, also known as Aitesile, is a proprietary TROP2 ADC from Kelun-Biotech. In May 2022, Kelun-Biotech granted Merck Sharp & Dohme LLC (MSD) exclusive rights for development, use, manufacture, and commercialization of sac-TMT outside Greater China. This marks the third NMPA-approved indication for sac-TMT in China, making it the first TROP2 ADC drug approved for a lung cancer indication globally.