Huadong Medicine's ADC Drug Elahere® Granted Full Approval in China, Marking Major Milestone in Oncology Innovation

　　【Pharmaceutical Network Enterprise NewsRecently, Huadong Medicine announced significant positive news: the supplemental application for the conditional approval of its wholly-owned subsidiary, Sinopharm Zhongmei Huadong's mirvetuximab soravtansine injection (brand name: Elahere), has been officially approved by the National Medical Products Administration (NMPA) for full regulatory approval. This event not only marks the clinical value of this ADC innovative drug being fully validated but also provides a more reliable new treatment option for platinum-resistant ovarian cancer patients in China.
 

The announcement shows that Simituzumab, co-developed by Huadong Medicine and ImmunoGen, Inc. (currently acquired by AbbVie), is an innovative ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer). It consists of an FRα-binding antibody, a cleavable linker, and the maytansine derivative DM4.
 

In November 2024, the marketing authorization application for mirvetuximab soravtansine injection for the treatment of FRα-positive platinum-resistant ovarian cancer (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.
 

In addition, in March 2024, AbbVie announced that the product had received full approval from the U.S. FDA for the treatment of adult patients with folate receptor alpha (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 had received marketing approval from the European Commission (EC) for the treatment of adult patients with 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.
 

The company stated that the approval of the 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 better clinical benefits.
 

It is reported that in terms of commercialization, Elahere® has demonstrated strong market potential. Relying on the "Hong Kong-Macao Drug and Medical Device Interflow" policy, Elahere has successfully entered the market, achieving sales revenue of over 45 million yuan from January to September 2025. Additionally, according to AbbVie's disclosure, in 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.
 

The industry believes that this approval is also a key step in Huadong Medicine's innovative transformation. The company stated that it will adhere to the corporate philosophy of "research-based, patient-centered," and rely on its existing R&D platform to increase investment in innovative drug products in the field of oncology ADC, continuously enriching the innovation pipeline. Ultimately, the company aims to achieve differentiated positioning and market competitiveness in the field of oncology ADC.
 

It is reported that Huadong Medicine has deeply focused on cutting-edge directions such as ADC for differentiated layout. The company has built a unique global ADC R&D ecosystem and is committed to creating an independent ADC industrial platform to form a core competitive barrier. To date, the company has 15 ADC pipeline layouts.
 

In May this year, Huadong Medicine announced that the clinical trial application for injectable HDM2005 had been approved by the National Medical Products Administration. This drug is an antibody-drug conjugate targeting ROR1, intended for the treatment of diffuse large B-cell lymphoma. Previously, the drug had received orphan drug designation from the U.S. FDA.
 

In June this year, Huadong Medicine announced that its self-developed Class 1 biological new drug "HDM2020 for Injection" received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA), and was approved to conduct clinical trials for advanced solid tumors. This drug is an antibody-drug conjugate (ADC) targeting fibroblast growth factor receptor 2b (FGFR2b). Preclinical studies have shown that the drug exhibits significant anti-tumor activity and good safety in models such as FGFR2b-positive gastric cancer and squamous non-small cell lung cancer.
 

Huadong Medicine, as one of the representative enterprises in innovative transformation, continues to focus on the three core therapeutic areas of oncology, endocrinology, and autoimmune diseases for the R&D layout of innovative drugs through independent development, external introduction, and project cooperation. As of October 2025, the company's Innovative Drug Research and Development Center is advancing over 90 innovative drug pipeline projects, covering various types of drug entities such as small molecule drugs, targeted protein degraders, peptide drugs, antibody-drug conjugates (ADCs), bispecific or multispecific antibodies, and small nucleic acid drugs. Currently, several key pipelines have entered the clinical harvest period. In 2025, the company’s innovative drug products have received six marketing approvals, demonstrating strong future growth potential.
 

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