On April 19, 2024, Shanghai Escugen Biotechnology Co., Ltd. ("Escugen") announced that its ESG401 (Trop-2 ADC) has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct a pivotal Phase III clinical trial for the indication of "HR+/HER2- metastatic breast cancer that has progressed after endocrine therapy or is unsuitable for endocrine therapy and has received at least one line of systemic chemotherapy in the metastatic setting." This decision was based on the overall excellent safety data from the ESG401-101 study and the consistent safety and highly competitive efficacy data obtained in the Phase Ib study for the same indication.