华东医药股份有限公司关于全资子公司获得药品补充申请批准通知书的公告

Core Viewpoint - The announcement highlights that Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for the conversion of the conditional approval of the drug Mirvetuximab Soravtansine Injection (ELAHERE) to regular approval, marking a significant milestone in the drug's development process [1][4][9]. Drug Information - The drug is known as Mirvetuximab Soravtansine Injection, with a specification of 100 mg (20 mL) per bottle, and is classified as a Class 3.1 therapeutic biological product [1][5]. - It is indicated for adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy and are positive for folate receptor alpha (FRα) [1][4]. Development and Approval History - The drug was developed in collaboration with ImmunoGen, Inc., which is now acquired by AbbVie, and is the first and only approved antibody-drug conjugate (ADC) targeting FRα for treating platinum-resistant ovarian cancer in China, the U.S., and the EU [5][6]. - The drug received accelerated approval from the U.S. FDA in November 2022 and full approval in March 2024, with subsequent approvals in the EU in November 2024 [6][7]. Clinical Trial Results - The approval for the regular application was based on the results of the Phase III clinical trial MIRASOL, which demonstrated a 35% reduction in the risk of tumor progression or death (HR 0.65, p<0.0001) and a 33% reduction in the risk of death (HR 0.67, p=0.0046) compared to the control group [7]. - The trial also indicated that the treatment group experienced fewer severe adverse events and lower rates of treatment discontinuation [7]. Market Performance and Sales - The drug has been actively marketed in China, with sales exceeding 45 million yuan from January to September 2025, and it has been successfully launched in several hospitals [8][9]. - AbbVie reported global net revenue of $508 million for ELAHERE in the first three quarters of 2025, with $453 million coming from the U.S. market [8].