HUADONG MEDICINE(SZ:000963) Zheng Quan Shi Bao Wang·2025-11-17 11:33Core Insights - Huadong Medicine's subsidiary has received full approval from the NMPA for the somatuzumab injection (ELAHERE), marking it as the first and only approved ADC drug for platinum-resistant ovarian cancer in China, the US, and the EU [1][2] - The drug is developed in collaboration with ImmunoGen, Inc. and targets the folate receptor alpha (FRα), which is highly expressed in ovarian cancer [1] - The approval is based on positive results from the pivotal Phase III MIRASOL trial, which demonstrated a 35% reduction in the risk of tumor progression or death and a 33% reduction in mortality risk compared to chemotherapy [1][3] Industry Context - Ovarian cancer, known as the "king of female cancers," poses significant treatment challenges, with a 5-year survival rate of only about 40% in China [2] - There is a pressing clinical demand for innovative therapies due to the limitations of traditional non-platinum chemotherapy, which has a response rate of less than 15% and a median progression-free survival of only 3-4 months [2] - The drug has already been launched in specific regions, with sales exceeding 45 million yuan in the first nine months of 2025, and it is expected to play a crucial role in addressing unmet clinical needs in platinum-resistant ovarian cancer [3]