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 platinum-resistant ovarian cancer (PROC) [2][3] 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 [2][3] - The approval is based on positive results from the pivotal Phase III clinical trial MIRASOL, confirming the drug's clinical efficacy [3] - Ovarian cancer, often referred to as the "king of women's cancers," poses significant treatment challenges, with a low five-year survival rate of approximately 40% in China [3] Group 2: Market Potential and Commercialization - The approval of ELAHERE® establishes a solid foundation for long-term and stable commercialization in the Chinese market, addressing the urgent need for effective treatment options [2][4] - The drug has already achieved sales revenue exceeding 45 million yuan from January to September 2025, indicating strong market demand and early sales momentum [4] - Huadong Medicine's strategic positioning and commercial capabilities are expected to facilitate rapid market penetration for ELAHERE® [4] Group 3: Innovation Pipeline and Growth Potential - Huadong Medicine is actively advancing over 90 innovative drug pipeline projects, focusing on oncology, endocrinology, and autoimmune diseases [6] - The company has received six drug approvals in 2025, showcasing its robust growth potential in the innovative drug sector [6][7] - The commercial success of ELAHERE® is a key milestone in Huadong Medicine's innovation strategy, reflecting its systematic innovation capabilities and long-term sustainable development [7]

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].