Stock Code: 002422
Stock Abbreviation: Kelun Pharmaceutical
Sichuan Kelun Pharmaceutical Co., Ltd.
Announcement No.: 2026-054
Announcement on Phase III Clinical Trial of TROP2 ADC Sacituzumab Govitecan (sac-TMT) Combined with Pembrolizumab Achieving Primary Endpoint in First-Line Treatment of PD-L1 Negative Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The Company and all members of the Board of Directors guarantee the truthfulness, accuracy, and completeness of the information disclosed, and that there are no false records, misleading statements, or major omissions.
Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") learned that its controlling subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd. (hereinafter referred to as "Kelun Botai"), has achieved the primary endpoint of its Phase III clinical trial (OptiTROP-Lung06) for sacituzumab govitecan (sac-TMT, also known as SKB264/MK-2870) (Enhertu®), an antibody-drug conjugate (ADC) targeting Trop-2, in combination with Merck's anti-programmed cell death protein-1 (PD-1) monoclonal antibody (hereinafter referred to as "antibody"), pembrolizumab (Keytruda®), in the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with PD-L1 negative status. The interim analysis, as confirmed by an independent Data Monitoring Committee (IDMC), met the primary endpoint of progression-free survival (PFS). This is the world's first Phase III clinical study of an ADC combined with an immune checkpoint inhibitor that has achieved its primary endpoint in the first-line treatment of driver gene-negative, PD-L1-negative non-squamous NSCLC. The core content is summarized as follows:
I. Basic Product Information