Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody–drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) for adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China.

The approval is based on the positive results from a randomized, controlled, phase 3 OptiTROP-Breast01 study in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. The results were presented at the special clinical science symposium for next-generation ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.

Previously, NMPA has accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for the treatment of patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) following progression on EGFR-TKI therapy only, or both EGFR-TKI and platinum-based chemotherapy, respectively.

Dr. Micheal Ge, CEO of Kelun-Biotech said, "It is a great pleasure to share with you the important milestone moment of the successful approval and launch of sacituzumab tirumotecan in China, which is a significant achievement of Kelun-Biotech's years of deep-rooted source innovation. As the company's first proprietary TROP2 ADC innovative drug, the successful launch of sacituzumab tirumotecan officially opens up a new pattern for the treatment of patients with 2L+ advanced TNBC. We expect that its excellent clinical efficacy and safety results will significantly enhance the clinical benefits and improve the quality of life of patients with advanced TNBC. In the future, we will continue to explore the clinical value of sacituzumab tirumotecan in other indications, maximize the market potential of sacituzumab tirumotecan, and satisfy the clinical needs of patients nationwide."