Huadong Medicine's ovarian cancer drug gains regular NMPA approval

On November 14, 2025, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, received notice from the National Medical Products Administration (NMPA) converting the conditional approval of Mirvetuximab Soravtansine Injection (ELAHERE) to regular approval. This drug is indicated for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that are FRα-positive and have received 1-3 prior lines of systemic therapy. The product is manufactured by BSP Pharmaceuticals S.p.A.

This supplementary application, approved on November 14, 2025, was based on results from the MIRASOL Phase II clinical trial, which demonstrated a 35% reduction in the risk of tumor progression or death compared to chemotherapy. The drug also showed a 33% reduction in the risk of death for treated patients. ELAHERE's global net revenue for the first three quarters of 2025 was $508m, with $453m from the US market.

The company's commercialization efforts in China have been successful, with the product achieving sales revenue exceeding CNY 45m from January to September 2025 through "Hong Kong and Macao Medicine Connect" policy. This approval marks a significant milestone in the drug's development.