China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to regular approval for Elahere (mirvetuximab soravtansine) has been accepted by the National Medical Products Administration (NMPA). This antibody drug conjugate (ADC) targets folate receptor α (FRα) and represents a significant step forward in the treatment of ovarian cancer.
Regulatory Milestones and Background
Elahere gained conditional approval from the NMPA in November last year for use in FRα-positive platinum-resistant ovarian cancer (PROC) previously treated with 1-3 line systemic therapies. The ADC was first approved in the United States in November 2022 and entered China via Hainan’s medical pilot zone in July 2023. Huadong acquired Greater China rights to the drug from ImmunoGen Inc. in a 2020 deal valued at up to USD305 million.
Global Collaborations and Market Potential
In August 2023, Japan’s Takeda Pharmaceutical Company (TYO: 4502) licensed the ADC for development and commercialization in Japan. This followed the completion of AbbVie’s USD10.2 billion acquisition of ImmunoGen in February of last year. These global partnerships highlight the potential of Elahere in addressing significant unmet needs in ovarian cancer treatment.-Fineline Info & Tech
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