喜讯！卵巢癌ADC全球首创新药爱拉赫 获常规批准，华东医药创新体系步入收获期

Core Viewpoint - The approval of Somatuzumab injection (ELAHERE) for the treatment of platinum-resistant ovarian cancer marks a significant milestone for the company, establishing a new era of targeted therapy in this field and providing a breakthrough treatment option for patients [1][2]. Group 1: Drug Approval and Clinical Significance - Somatuzumab injection is the first-in-class ADC drug targeting folate receptor alpha (FRα), approved for treating platinum-resistant ovarian cancer (PROC) [2]. - The transition from conditional to regular approval was based on positive results from the Phase III clinical trial MIRASOL, which demonstrated a 35% reduction in the risk of tumor progression or death and a 33% reduction in mortality risk compared to chemotherapy [2][3]. - The drug's approval reflects the recognition of its significant clinical value and efficacy in a difficult-to-treat patient population [2][3]. Group 2: Market Potential and Sales Performance - The drug has achieved rapid market entry and early sales growth in China, with sales revenue exceeding 45 million yuan in the first nine months of 2025 [4]. - In the overseas market, ELAHERE generated $170 million in sales in Q3 2025, a 22.3% year-on-year increase, with total sales for the first three quarters reaching $508 million, up 53.5% [4]. - The company's established commercialization system and channel advantages position it well to capture market share in the domestic market, leveraging its unique first-mover status [4]. Group 3: Innovation Pipeline and Future Growth - The company has a robust innovation pipeline with over 90 projects in development, focusing on oncology, endocrinology, and autoimmune diseases [5][6]. - In 2025, the company received six drug approvals, indicating strong future growth potential [6]. - The successful transition of ELAHERE to regular approval is a key milestone in the company's innovation strategy, showcasing its ability to build a differentiated product pipeline in core therapeutic areas [7].