Huadong Medicine's ADC Innovative Drug Elahere® Receives NMPA Full Approval Following Conditional Approval

Mirvetuximab Soravtansine is an innovative ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer) co-developed by Huadong Medicine and ImmunoGen, Inc. (currently acquired by AbbVie). It consists of an FRα-binding antibody, a cleavable linker, and the maytansinoid DM4. In China, the United States, and the European Union, it is the first and currently the only approved ADC drug targeting FRα for the treatment of platinum-resistant ovarian cancer (PROC). Huadong Medicine holds exclusive rights to the clinical development and commercialization of this product in Greater China. In March 2024, AbbVie announced that the product received full approval from the U.S. FDA for the treatment of adult patients with folate receptor α (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy. In November 2024, AbbVie announced that the product received marketing approval from the European Commission (EC) for the treatment of adult patients with folate receptor α (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy.

In November 2024, the marketing authorization application for Mirvetuximab Soravtansine Injection for the treatment of FRα-positive PROC patients who have previously received 1-3 lines of systemic therapy was granted conditional approval by the NMPA in China; the supplemental application for the product to transition from conditional approval to full approval was accepted in March 2025 and successfully passed the clinical inspection in August 2025.

The supplemental application for the conversion to full approval of mirvetuximab soravtansine injection has been approved based on the results of the confirmatory Phase III clinical trial MIRASOL. This trial is a randomized study comparing the efficacy and safety of mirvetuximab soravtansine versus investigator’s choice (IC) monotherapy chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan) in patients with platinum-resistant ovarian cancer. The trial met its primary endpoint, PFSINV, with a hazard ratio (HR) of 0.65 (p<0.0001), indicating a 35% reduction in the risk of tumor progression or death in the mirvetuximab soravtansine group compared to the IC chemotherapy group. It also achieved a key secondary endpoint, OS, with an HR of 0.67 (p=0.0046), showing a 33% reduction in the risk of death in the mirvetuximab soravtansine group compared to the IC chemotherapy group. Compared to the IC chemotherapy group, the mirvetuximab soravtansine group had fewer grade 3 or higher adverse events overall and a lower rate of treatment discontinuation due to adverse events. Mirvetuximab soravtansine provides clinically meaningful benefits in the highly underserved PROC population.

In addition, the product has been piloted in the Boao Lecheng Pilot Zone in Hainan in July 2023, and officially launched its real-world study for platinum-resistant ovarian cancer at Boao Ruijin Hospital in Hainan in August 2023. The product was approved for marketing in Macao, China in April 2024, and passed the innovative policy approval of the "Hong Kong-Macao Medicine and Device Connect" in August 2024, landing in the Guangdong-Hong Kong-Macao Greater Bay Area. Relying on the "Hong Kong-Macao Medicine and Device Connect" policy to open up the market first, Elah.^®From January to September 2025, sales revenue exceeding 45 million yuan has been achieved; the official launch of this product in the Chinese market is proceeding smoothly. In November 2025, the product successfully issued the first prescriptions in China at Fudan University Cancer Hospital and Sun Yat-sen University's Sun Yat-sen Memorial Hospital. According to AbbVie’s disclosure, during the first three quarters of 2025, ELAHERE's global net revenue reached 508 million US dollars, with 453 million US dollars coming from the US market.

Platinum-resistant ovarian cancer is resistant to platinum-based chemotherapy, with a short survival period and significant unmet clinical needs. The injection of Mirvetuximab soravtansine has received full approval in the United States for this indication. In patients with FRα-positive PROC, the NCCN Guidelines (2024 Version 3) give priority recommendation to the injection of Mirvetuximab soravtansine.

The approval of this supplemental application for the Mirvetuximab Soravtansine Injection marks another significant milestone in the development of this product. The company will actively promote the commercialization of Elahere® in the Chinese market, providing patients with a treatment option that offers superior clinical benefits. At the same time, the company will adhere to its corporate philosophy of "research-based and patient-centered," and leverage its existing R&D platform to increase investment in innovative drug products in the field of oncology ADCs, continuously enriching its innovative pipeline. Ultimately, this will enable the company to achieve a differentiated layout and leading market competitiveness in the field of oncology ADCs.