Klus Pharma Inc.

Ellipses Pharma launches first large-scale Phase 1/2 oncology trial in UAE for EP0031/A400, a next-gen RET inhibitor targeting RET-altered tumors, with trials underway in the US, Europe, and China.

The FDA granted breakthrough therapy designation to sacituzumab tirumotecan (sac-TMT) for treating advanced or metastatic nonsquamous NSCLC with EGFR mutations (exon 19 deletion or exon 21 L858R) that progressed after TKI and platinum-based chemotherapy. This decision is based on phase 2 expansion cohort data from a phase 1/2 study. Sac-TMT is an investigational TROP2-directed ADC, currently undergoing phase 3 trials in various solid tumors, including NSCLC (TroFuse-004 and TroFuse-009).

Merck & Co. announced FDA Breakthrough Therapy designation for sacituzumab tirumotecan (sac-TMT) to treat advanced or metastatic nonsquamous non-small cell lung cancer with EGFR mutations. Sac-TMT is a TROP2-directed ADC developed with Kelun-Biotech, targeting patients whose disease progressed after TKI and platinum-based chemotherapy. Merck is advancing sac-TMT's clinical development globally, including 10 ongoing Phase 3 studies, and recently received its first marketing authorization in China for certain unresectable locally advanced or metastatic triple-negative breast cancer.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced the marketing authorization of sacituzumab tirumotecan (sac-TMT), the first domestically developed TROP2 ADC for treating unresectable locally advanced or metastatic TNBC in China. The approval is based on the OptiTROP-Breast01 study, which showed significant improvements in PFS and OS compared to chemotherapy.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced the marketing authorization of sacituzumab tirumotecan (sac-TMT), the first domestically developed TROP2 ADC for treating unresectable locally advanced or metastatic TNBC in China.