Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that its TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with pembrolizumab (KEYTRUDA®), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. This designation is for the first-line treatment of patients with locally advanced or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who are EGFR-negative and ALK-negative. The designation follows positive results from the Phase III OptiTROP-Lung05 trial, which showed significant improvement in progression-free survival. The BTD status is expected to expedite the review and potential approval process of the combination therapy for this indication.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN56004) on January 05, 2026, and is solely responsible for the information contained therein.