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: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.