Core Viewpoint - The acceptance of the new drug application (NDA) for TLX591-CDx by the National Medical Products Administration marks a significant advancement for the company in the field of nuclear medicine for cancer diagnosis [1][2]. Group 1: Product Development and Market Potential - TLX591-CDx is a diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for diagnosing both newly diagnosed and recurrent prostate cancer [1]. - The NDA application includes data from a clinical study conducted in China, which is a Phase III open-label study involving over 100 patients with biochemical recurrence of prostate cancer [1]. - The incidence of prostate cancer in China is on the rise, with projections indicating nearly 200,000 new cases by 2030 according to Frost & Sullivan data [1]. Group 2: Commercial Performance and Expansion - TLX591-CDx has been approved for commercialization in 24 countries, including Australia, the USA, and several European nations, demonstrating strong commercial performance with 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% [2]. - The acceptance of the NDA is a crucial step in the company's strategy to build an integrated diagnostic and therapeutic product portfolio for prostate cancer, with the complementary therapeutic product TLX591 already approved for international Phase III clinical studies in China [2]. Group 3: Strategic Positioning and Future Outlook - The company has established a comprehensive layout in the nuclear medicine sector, covering research and development, production, distribution, and sales [2]. - The ongoing "Go Global" strategy and the anticipated launch of TLX591-CDx and other innovative products are expected to enhance the company's core competitiveness in the nuclear medicine field [2].
远大医药创新RDC药物TLX591-CDx新药上市申请获国家药监局受理