Group 1 - The company YuanDa Pharmaceutical Group has received formal acceptance from the National Medical Products Administration for its innovative radiopharmaceutical drug TLX591, aimed at treating metastatic castration-resistant prostate cancer (mCRPC) [2] - TLX591 is set to be evaluated in a global Phase III clinical trial involving over 500 patients across multiple countries, including China, the USA, Australia, and New Zealand, comparing its efficacy and safety against standard treatment [2] - Prostate cancer is a common malignancy among elderly men, ranking second in incidence and fifth in mortality among male cancers globally, and sixth and seventh in China respectively [2] Group 2 - The global prostate cancer treatment market was estimated at $15.2 billion in 2021 and is projected to grow to $24.9 billion by 2030 [3] - Traditional radiotherapy for prostate cancer in China has high cumulative radiation doses, leading to complications that significantly affect patients' quality of life, indicating a clinical need for lower radiation exposure treatment options [3] - YuanDa Pharmaceutical is focusing on the global development strategy of nuclear medicine for oncology, aiming to expedite the registration and commercialization of innovative nuclear drugs, with TLX591 potentially becoming a significant product for the company [3]
远大医药创新核药TLX591国际多中心Ⅲ期临床国内IND获受理