China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), for the treatment of FRα positive platinum-resistant ovarian cancer (PROC) in patients who have previously undergone 1-3 line systemic therapies.
Huadong’s Acquisition and Development Rights
Huadong acquired the Greater China development and commercial rights to mirvetuximab soravtansine from ImmunoGen Inc., in an October 2020 deal valued at up to USD 305 million. US-based AbbVie (NYSE: ABBV) acquired mirvetuximab soravtansine through its USD 10.1 billion buyout of ImmunoGen in December of the following year, securing a market nod for the drug in the European Union (EU) earlier this month.
ADC’s Regulatory Progress and Market Introduction
The ADC was fast-tracked for marketing in the US in November 2022 and received full approval in March of this year. Elahere was introduced at Ruijin Hospital’s Hainan branch in July last year for the treatment of FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adult patients who have previously received 1-3 systemic treatments. The drug was approved for marketing in Macau in April this year and received approval in the Greater Bay Area (GBA) due to the “Hong Kong-Macau Drug and Device Access” policy, which allows patients access to drugs across Hong Kong, Macau, and various cities in Guangzhou.-Fineline Info & Tech
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