ADC靶向疗法
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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
Zheng Quan Ri Bao Zhi Sheng· 2025-11-17 13:06
Core Viewpoint - Huadong Medicine's first-in-class drug, ELAHERE® (sotiracizumab injection), has transitioned from conditional approval to regular approval by the National Medical Products Administration (NMPA), marking a significant milestone in the treatment of FRα-positive platinum-resistant ovarian cancer (PROC) [1][2]. Group 1: Drug Approval and Clinical Significance - ELAHERE® is the first targeted antibody-drug conjugate (ADC) approved for PROC, demonstrating a breakthrough in treatment options for patients who have undergone 1-3 lines of systemic therapy [1][2]. - The transition to regular approval is based on positive results from the pivotal Phase III clinical trial MIRASOL, indicating the drug's clinical research data has received full regulatory recognition [1][2]. Group 2: Market Potential and Sales Performance - The drug has shown significant market potential, with sales exceeding 45 million yuan from January to September 2025, and it has been successfully launched in key hospitals [3]. - Huadong Medicine's established commercialization system and channel advantages position ELAHERE® to quickly penetrate the domestic market, reinforcing the company's leading position in the field of gynecological oncology [3]. Group 3: Innovation Pipeline and Growth Strategy - 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 drug approvals in 2025, showcasing strong future growth potential and a systematic approach to innovation [4][6]. - The commercial success of innovative products, including CAR-T therapies and other new drugs, has led to a significant revenue increase of 62% in the pharmaceutical industrial segment from January to September 2025 [5][6].