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强生(JNJ.US)重磅产品国内申报新适应症
智通财经网· 2025-08-23 12:57
Core Viewpoint - Johnson & Johnson's (JNJ.US) application for the new indication of Niraparib Abiraterone tablets has been accepted, with speculation that the indication is for hormone-dependent prostate cancer [1]. Group 1: Product Information - Niraparib Abiraterone is a compound formulation launched by Johnson & Johnson, which received approval in the EU and the US in 2023 for use in combination with prednisone or prednisolone for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients with BRCA1/2 mutations [2]. - The drug is set to be the first and only dual-action compound formulation approved in China, with its domestic approval expected in October 2024 [2]. Group 2: Safety Profile - The incidence of grade 3/4 adverse events (AEs) in the trial group was 75.2%, compared to 58.9% in the control group, with the most common AEs being anemia and hypertension [3]. - The rate of discontinuation due to AEs was relatively low at 11.0% for the trial group versus 6.9% for the control group [3].