Kelun-Biotech Reports 2025 Financial Results with Multiple ADC Product Launches
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. announced its audited consolidated results for the year ended 31 December 2025, reporting revenue of approximately RMB2057.92 million and gross profit of approximately RMB1478.78 million, representing a year-on-year increase. The company reported a loss for the period of RMB381.97 million, with adjusted annual loss of approximately RMB211.28 million, while maintaining cash and financial assets of approximately RMB4559.36 million and reducing its debt-to-asset ratio to 18.7%.
Research and development expenses amounted to approximately RMB1319.68 million as the company continues to deepen its presence in the antibody-drug conjugate and novel conjugated drug field. Kelun-Biotech is leveraging its proprietary OptiDC™ technology platform to advance cutting-edge modalities including bispecific ADCs, RDCs, iADCs, and DACs, building a differentiated pipeline with strong global competitiveness.
To date, the company has four products with eight indications approved for marketing in China, including Sacituzumab Tirumotecan (佳泰莱®), Trastuzumab Botidotin (舒泰莱®), Tagitanlimab (科泰莱®), and Cetuximab N01 (达泰莱®). Among them, three products with five indications have been included in the 2025 National Reimbursement Drug List, establishing a fully integrated drug development ecosystem that spans R&D through commercialization.
The company has built a robust pipeline of more than 30 drug candidates, with over 10 in the clinical stage, and is gradually expanding into broader non-oncology therapeutic areas such as autoimmune diseases and metabolic disorders.
For its core ADC product Sac-TMT (sacituzumab tirumotecan, TROP2 ADC), the company received marketing authorization in China for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies. In February 2026, a new indication application for sac-TMT for the treatment of adult patients with HR+/HER2- breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting was approved for marketing by the NMPA.
For EGFR-mutant non-small cell lung cancer, the company received marketing authorization in China in March 2025 for sac-TMT following progression on EGFR-TKI therapy and platinum-based chemotherapy, marking the first TROP2 ADC drug approved for marketing in lung cancer globally. In October 2025, the company received additional marketing authorization for sac-TMT for adult patients with EGFR mutant-positive NSCLC who progressed after treatment with EGFR-TKI therapy alone, representing the first ADC globally to show an overall survival benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC following progression on only TKI therapy.
The Phase 3 registrational study of sac-TMT in combination with pembrolizumab versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint, marking the first Phase 3 clinical trial of an ADC combined with an immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC. In January 2026, sac-TMT in combination with pembrolizumab for the first-line treatment of PD-L1 positive NSCLC were granted breakthrough therapy designation.