Sacituzumab Tirumotecan (TROP2 ADC) in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Locally Advanced or Metastatic NSCLC Granted Breakthrough Therapy Designation by NMPA
January 5, 2026
Source: drugdu
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People’s Fortune News, Jan 5 — Sichuan Kelun Pharmaceutical (002422.SZ) announced on the morning of January 5 that its holding subsidiary, Kelun-Biotech, has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for its TROP2-targeted antibody-drug conjugate (ADC), Sacituzumab Tirumotecan (sac-TMT, also known as SKB264/MK-2870; brand name: Jiatailai®).
The designation applies to the combination of sac-TMT and MSD’s anti-PD-1 monoclonal antibody, Pembrolizumab (Keytruda®), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a PD-L1 tumor proportion score (TPS) ≥1% and are negative for EGFR mutations and ALK rearrangements.
Additionally, Kelun-Biotech’s self-developed integrin β6 (ITGB6)-targeted ADC, SKB105 (also known as CR-003), has received Investigational New Drug (IND) approval from the CDE for clinical trials in the treatment of advanced solid tumors.
https://finance.eastmoney.com/a/202601053608098625.html
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