全球首创靶向FRαADC药物爱拉赫 获常规批准 华东医药肿瘤创新治疗领域再下一城

Core Insights - Huadong Medicine's first-in-class drug, Somatuximab Injection (ELAHERE), has transitioned from conditional approval to regular approval by the National Medical Products Administration (NMPA) for treating FRα-positive platinum-resistant ovarian cancer (PROC) [1][2][3] - This approval marks a significant milestone in the drug's clinical research and establishes a solid foundation for its long-term commercialization in the Chinese market [1][2] Drug Details - Somatuximab Injection targets folate receptor alpha (FRα), which is highly expressed in ovarian cancer, and is composed of an FRα-binding antibody, a cleavable linker, and the cytotoxic agent DM4 [2] - The drug's regular approval is based on positive results from the pivotal Phase III clinical trial MIRASOL [2] Market Context - Ovarian cancer, often referred to as the "king of women's cancers," poses significant treatment challenges due to late diagnosis, high recurrence rates, and low survival rates [2] - In 2022, there were approximately 61,100 new cases and 32,600 deaths from ovarian cancer in China, with a five-year survival rate of only about 40% [2] Commercialization and Sales - ELAHERE has achieved sales revenue exceeding 45 million yuan from January to September 2025, with successful early sales in the domestic market [3] - The drug is expected to quickly penetrate the domestic market due to Huadong Medicine's established commercialization system and channel advantages [3] Innovation Pipeline - Huadong Medicine is focusing on innovation in oncology, endocrinology, and autoimmune diseases, with over 90 innovative drug pipeline projects currently in progress [4] - The company has received six marketing approvals for innovative drugs by October 2025, indicating strong future growth potential [4] Financial Performance - From January to September 2025, Huadong Medicine's pharmaceutical industrial segment reported a significant revenue increase of 62%, totaling 1.675 billion yuan from innovative products and agency services [5] - The company has demonstrated strong market performance with its CAR-T product and other innovative drugs, reflecting its effective commercialization strategy [5][6]