The board of directors of Everest Medicines Limited announced that it has initiated the submission of a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with metastatic triple- negative breast cancer ("mTNBC") who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan-hziy is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Sacituzumab govitecan-hziy was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. According to data from the pivotal Phase 3 ASCENT trial, treatment with sacituzumab govitecan-hziy reduced the risk of death by 52% (p <0.0001), reduced the risk of disease progression by 59% (p <0.0001) and increased median overall survival (12.1 vs. 6.7 months) compared with chemotherapy. Under a licensing agreement with Gilead Sciences Inc., the Company has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for approximately 15%­20% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in China than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.