Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment

Reuters

05/22

Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the Center for Drug Evaluation $(CDE)$ of the National Medical Products Administration (NMPA) of China has accepted the new indication application for their TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This marks the fourth indication application for sac-TMT accepted by the NMPA, highlighting the drug's clinical value and innovative nature. The application will undergo the priority review and approval process, following positive results from the registrational phase 3 OptiTROP-Breast02 study. This development underscores Kelun-Biotech's commitment to advancing oncology therapeutics to meet unmet clinical needs worldwide.

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: CN94038) on May 22, 2025, and is solely responsible for the information contained therein.

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