Core Viewpoint - The company has achieved positive topline results in the Phase III clinical trial of its innovative radiopharmaceutical TLX591-CDx for prostate cancer diagnosis, meeting the primary clinical endpoint [1] Group 1: Product Development - TLX591-CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for both initial diagnosis and recurrent prostate cancer [1] - The company has secured exclusive rights for multiple innovative RDC products, including TLX591-CDx, in Greater China through a strategic cooperation agreement with Telix [1] - TLX591-CDx has been approved for sale in several countries, including the US, Australia, Canada, Brazil, and the UK, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a year-on-year growth of over 25% [1] Group 2: Research and Development - The company has initiated an international multicenter Phase III clinical study for another innovative RDC product, TLX591, in China [2] - The company has established a comprehensive layout in the nuclear medicine sector, covering research, production, distribution, and sales, with R&D bases in Boston and Chengdu [2] - The product pipeline includes 16 innovative products in the research registration stage, utilizing five types of radioactive isotopes and covering seven cancer types, including liver cancer and brain cancer [2] Group 3: Industry Positioning - The company has six innovative RDC products approved for registration clinical research, with four currently in Phase III clinical trials, indicating a harvest period for innovative nuclear medicine products [2] - The nuclear medicine R&D and production base in Chengdu received a Class A Radiation Safety License in May 2025 and commenced operations in June 2023, meeting the demand for various therapeutic and diagnostic nuclear medicines [2]
远大医药：前列腺癌诊断创新核药TLX591-CDx国内III期达到主要临床终点