Sichuan Kelun Pharmaceutical (002422.SZ): The approval of the second indication (for the treatment of EGFR mutant non-small cell lung cancer) of Lankashatuzumab monotherapy is now on the market.

Sichuan Kelun Pharmaceutical (002422.SZ) announced that its controlled subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd. (referred to as "Kelun Botai") recently received approval from the National Medical Products Administration (NMPA) for the second indication of the antibody-drug conjugate (ADC) targeting the human trophoblast cell surface antigen 2 (TROP2) called sacituzumab govitecan (sac-TMT, formerly known as SKB264/MK-2870) under the brand name Joytala, for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in adults with EGFR gene mutations who have progressed after treatment with EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. This is the first TROP2 ADC drug approved for lung cancer indication globally. Compared to standard treatments, sacituzumab govitecan (sac-TMT) significantly prolongs the overall survival benefits for these patients. This approval was based on a multicenter, randomized, controlled pivotal clinical study (OptiTROP-Lung03), which evaluated the efficacy and safety of sacituzumab govitecan (sac-TMT) as a monotherapy at a dose of 5mg/kg intravenously every two weeks (Q2W) compared to docetaxel in patients with locally advanced or metastatic EGFR mutation NSCLC who had failed previous EGFR-TKI and platinum-based chemotherapy (sequentially or in combination). The interim analysis results showed that compared to docetaxel, sacituzumab govitecan (sac-TMT) as a monotherapy demonstrated significant and clinically meaningful improvements in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).