恒瑞医药：创新药卡瑞利珠单抗联合法米替尼获国家药监局复发或转移性宫颈癌一线治疗上市许可受理

Core Event - Heng Rui Medicine received the acceptance notice from the National Medical Products Administration for the marketing authorization application of the innovative drug injection of Carrelizumab combined with Apalutamide capsules for first-line treatment of recurrent or metastatic cervical cancer patients [1] Clinical Trial Data - Trial Design: Phase III randomized controlled multicenter study involving 45 domestic centers with 443 patients enrolled [2] - Trial Results: The trial met its primary endpoint, with the experimental group showing significantly better progression-free survival (PFS) and overall survival (OS) compared to the control group [2] Market Background - Indication: Cervical cancer has the highest incidence and mortality rates among female reproductive system tumors in China, indicating an unmet clinical need [2] - Competitive Landscape: The global sales of anti-PD-1 antibodies are projected to reach approximately $41.546 billion in 2024 [2] R&D Investment - Cumulative R&D investment in Carrelizumab is approximately 3.026 billion yuan [2] - Cumulative R&D investment in Apalutamide is approximately 258 million yuan [2]