On the evening of November 17th, Huadong Medicine(000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its supplemental application to change from conditional approval to regular approval for somituximab injection (ELAHERE®).
　　The announcement indicates that somituximab is the first and currently only FRα-targeting ADC drug approved in China, the United States, and the European Union for the treatment of platinum-resistant ovarian cancer (PROC). Hangzhou Sino-American East China Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, holds exclusive clinical development and commercialization rights for this product in Greater China.
　　It is understood that somituximab is an innovative ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer), developed in collaboration between Sino-American Huadong and Immuno Gen, Inc. (now acquired by AbbVie).It consists of an FRα-binding antibody, a cleavable linker, and maytansine alkaloid DM4.
　　The successful transition of somituximab injection from conditional to routine approval was based on the positive results of the confirmatory Phase III clinical trial MIRASOL. This study showed that, compared to the chemotherapy group, patients treated with somituximab had a 35% lower risk of tumor progression or death, significantly prolonged overall survival (a 33% reduction in the risk of death), and demonstrated superior safety. These results confirm its significant efficacy and clinical value in the platinum-resistant ovarian cancer population, a difficult-to-treat condition.
　　Ovarian cancer, often referred to as the "king of gynecological cancers," is one of the most aggressive types of gynecological malignancies. Clinical treatment has long faced severe challenges, including late diagnosis, high recurrence rate, and low survival rate.
　　According to the latest data from the National Cancer Center in 2024, there were approximately 61,100 new cases of ovarian cancer and 32,600 deaths annually in China in 2022, with a 5-year survival rate of only about 40%. About 70% of patients are diagnosed at an advanced stage, and the vast majority develop platinum resistance after multiple lines of treatment. Traditional non-platinum chemotherapy regimens have an objective response rate of less than 15%, a median progression-free survival of only 3-4 months, limited efficacy, and significant side effects. Faced with this grim situation, there is an urgent clinical need for precise and efficient new treatment options, which brings clear clinical value and market potential to innovative drugs with breakthrough efficacy.
　　Airah® was piloted in the Boao Lecheng Pilot Zone in Hainan in July 2023, and its real-world study for platinum-resistant ovarian cancer was officially launched at Ruijin Hospital in Boao, Hainan in August 2023. The product was approved for marketing in Macau, China in April 2024, and passed the "Hong Kong and Macau Drug and Medical Device Connect" innovation policy approval in August 2024, thus launching in the Guangdong-Hong Kong-Macau Greater Bay Area.
　　Leveraging the "Hong Kong and Macao Medical Device and Drug Access Link" policy, ELAHERE® achieved sales revenue exceeding RMB 45 million from January to September 2025. The official launch of the product in the domestic market is progressing smoothly; in November 2025, the product was successfully prescribed in the first batches at Fudan University Cancer Hospital and Sun Yat-sen Memorial Hospital of Sun Yat-sen University. According to AbbVie, in the first three quarters of 2025, ELAHERE's global net revenue was US$508 million, of which US$453 million was from the US market.
　　The announcement indicates that platinum-resistant ovarian cancer patients are resistant to platinum-based chemotherapy, have short survival rates, and represent a significant unmet clinical need. Somituximab injection has received full approval for this indication in the United States, and the NCCN guidelines (2024 Version 3) prioritize the recommendation of somituximab injection in FRα-positive PROC patients.
　　This approval marks a significant milestone in the drug's marketing authorization process, signifying full recognition of its clinical research data by regulatory authorities. It not only lays a solid foundation for the long-term, stable commercial supply of the drug in the Chinese market but also formally establishes PROC therapy as entering the ADC-targeted era, providing a groundbreaking new option for clinical practice.

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