China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China.
Acquisition and Development Rights
Huadong Medicine acquired the development and commercial rights for mirvetuximab soravtansine in Greater China from ImmunoGen Inc. in a deal signed in October 2020, valued at up to USD 305 million. The ADC has been a focus of regulatory attention, receiving priority review status in the US in May 2022 and fast-tracked for marketing in November 2022.
Clinical Application and Expansion
Elahere was introduced at Ruijin Hospital’s Hainan branch in July of this year for the treatment of FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adult patients who have received 1-3 prior systemic treatments. This initiative broadens the therapeutic options for patients with these challenging conditions.
Global Licensing and Partnerships
In August 2023, Japan’s Takeda (TYO: 4502) entered into a licensing deal with ImmunoGen to develop and commercialize the ADC in Japan, highlighting the global interest in Elahere’s potential as a treatment for ovarian and related cancers.-Fineline Info & Tech
