Kelun's lung cancer therapy gains breakthrough designation in China

Sichuan Kelun Pharmaceutical (SZSE:002422) announced that its subsidiary, Kelun-Biotech, has received breakthrough therapy designation from China's National Medical Products Administration (NMPA) for its TROP2 ADC, sac-TMT (佳泰莱®), in combination with the PD-L1 monoclonal antibody, taglizumab (科泰莱®). This designation applies to the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations. This marks the fifth breakthrough therapy designation for sac-TMT. The breakthrough therapy designation is intended to expedite the development and approval of innovative drugs that demonstrate a significant clinical advantage over existing treatments, addressing unmet medical needs. Sac-TMT has already received approval in China for certain TNBC and EGFR-mutated NSCLC indications. Phase 2 OptiTROP-Lung01 study data supporting this designation was presented at the 2025 ASCO Annual Meeting.