Core Insights - The article highlights the significant milestone achieved by YuanDa Pharmaceutical with its innovative nuclear medicine product, SIR-Spheres Yttrium-90 microsphere injection, which has received FDA approval for dual indications in treating unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastases [1][2][3] Product Development and Approval - SIR-Spheres Yttrium-90 microsphere injection is the first and only selective internal radiation therapy (SIRT) product globally approved by the FDA for both unresectable HCC and colorectal cancer liver metastases, showcasing its clinical value [1][2] - The product achieved a remarkable objective response rate of 98.5% and a local tumor control rate of 100% in the DOORwaY90 clinical trial, with a median duration of response exceeding 300 days [2][3] - The FDA's early approval for the new indication of unresectable HCC, without restrictions on tumor diameter, reflects the product's significant advantages over competitors [2][3] Market Potential and Clinical Impact - The global liver cancer treatment market is projected to reach USD 9.81 billion by 2030, indicating a substantial opportunity for innovative therapies like SIR-Spheres [7] - With liver cancer being the sixth most common and the third deadliest cancer globally, and China accounting for a significant portion of new cases and deaths, the product is positioned to address a critical healthcare need [4][7] Company Positioning and Strategy - YuanDa Pharmaceutical has established a comprehensive nuclear medicine ecosystem, encompassing research, production, sales, and regulatory compliance, positioning itself as a leader in the nuclear medicine field [8][15] - The company has a robust pipeline of 15 innovative products targeting various cancers, supported by a state-of-the-art production facility that meets international standards [8][13][15] - The successful operation of the Chengdu Wenjiang nuclear medicine R&D and production base marks a strategic leap for the company, enabling it to meet global demand for therapeutic and diagnostic nuclear medicines [13][15]
远大医药(00512)易甘泰®海外临床取得突破性中期数据，获FDA提前正式批准拓展HCC适应症，或重塑肝癌治疗格局