China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a maintenance therapy for patients with FRα-positive, recurrent, platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have not progressed after second-line treatment with platinum-based chemotherapy.
The ADC was brought into Huadong’s portfolio through a significant deal with ImmunoGen Inc. in October 2020, which granted the company development and commercial rights for Greater China with a potential value of up to USD 305 million. This strategic acquisition highlights Huadong’s commitment to expanding its presence in the oncology space. The drug received its initial marketing approval in the United States in November 2022, marking a significant milestone for the treatment of FRα-positive cancers.
Elahere gained fast-track entry through Hainan’s medical pilot zone in July of the previous year, where a real-world study for the drug in platinum-resistant ovarian cancer was initiated. This move underscored the drug’s potential to address a critical unmet need in cancer treatment. In August 2023, Takeda, a leading pharmaceutical company in Japan (TYO: 4502), entered into a licensing agreement with ImmunoGen to develop and commercialize the ADC in Japan, further expanding the drug’s global reach.
The recent acquisition of ImmunoGen by AbbVie for USD 10.2 billion in February this year further emphasizes the importance of Elahere in the global oncology market. With this clinical trial approval in China, Huadong Medicine is poised to play a pivotal role in bringing this innovative therapy to patients in need.- Flcube.com
