全球核药龙头大消息

Core Viewpoint - Global nuclear medicine leader, YuanDa Pharmaceutical, has achieved a significant milestone in overseas research and development, particularly in the treatment of unresectable hepatocellular carcinoma (HCC) with its innovative product SIR-Spheres® Yttrium-90 microsphere injection (EganTai®) [2] Group 1: Product Approval and Market Potential - The FDA has granted early approval for SIR-Spheres® Yttrium-90 microsphere injection for the treatment of unresectable HCC, with no restrictions on tumor diameter, marking it as the first and only product approved for both unresectable HCC and colorectal cancer liver metastases [2][3] - The product utilizes advanced interventional techniques to deliver high-energy beta radiation directly to liver tumors, combining the benefits of radiopharmaceuticals and precise interventional therapy [3] - The global liver cancer treatment market is projected to reach $9.81 billion by 2030, indicating a substantial opportunity for innovative treatments like EganTai® [5] Group 2: Clinical Recognition and Usage - Since its launch, SIR-Spheres® has been used by over 150,000 patients across more than 50 countries, receiving endorsements from multiple international clinical guidelines [4] - In China, EganTai® has treated nearly 2,000 patients, achieving sales revenue of approximately HKD 500 million in 2024, with a year-on-year growth rate exceeding 140% [4] Group 3: Comprehensive Industry Position - YuanDa Pharmaceutical has established a full industry chain in nuclear medicine, encompassing research, production, sales, and regulatory qualifications, positioning itself as a leading player in the field [6] - The company has a robust pipeline of 15 innovative products targeting various cancers, including prostate, kidney, and brain cancers, utilizing five types of radioactive isotopes [6][7] - YuanDa aims to strengthen its nuclear medicine segment and expand its product pipeline, focusing on creating a comprehensive cluster of anti-tumor diagnostic and therapeutic products centered around EganTai® [7]