Kelun-Biotech’s Sac-TMT Achieves First ADC-IO NSCLC Success

Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that sacituzumab tirumotecan (sac-TMT), its proprietary TROP2 ADC, in combination with pembrolizumab (Keytruda), achieved positive results in the Phase 3 OptiTROP‑Lung05 study for first‑line PD‑L1‑positive NSCLC, marking the first ADC‑plus‑immune checkpoint inhibitor regimen to reach a primary endpoint in front‑line NSCLC.

Trial Milestone

Drug Profile

• Mechanism: Novel TROP2 ADC with proprietary linker‑payload technology
• Current China Approvals: 3 indications (TNBC, EGFR+ NSCLC post‑TKI)
• Global Rights: Partnered with MSD (Merck) since May 2022 for development and commercialization outside Greater China
• Differentiation: Synergistic ADC‑IO activity demonstrates potential to reshape first‑line NSCLC treatment paradigm

Clinical Evidence – OptiTROP-Lung05

Market Impact & Outlook

• Reimbursement Path: Supplemental NDA likely qualifies for Priority Review; potential NRDL inclusion 2027
• Pipeline Expansion: Kelun‑Biotech is evaluating sac‑TMT in first‑line TNBC and other solid tumors; MSD advancing global Phase III program

Forward‑Looking Statements
This brief contains forward‑looking statements regarding sac‑TMT’s regulatory review, commercial potential, and partnership outcomes. Actual results may differ materially due to risks including NMPA approval timelines, competitive responses, and MSD collaboration execution.-Fineline Info & Tech