Core Viewpoint - AstraZeneca and Merck have announced that the National Medical Products Administration (NMPA) has approved the use of the PARP inhibitor Olaparib in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer carrying germline or somatic BRCA mutations [1] Group 1: Approval and Clinical Data - The NMPA's approval is based on the results of the PROpel Phase III trial, which included global and Chinese cohort subgroup analyses [1] - Data from the global cohort of patients with BRCA mutations showed a significant improvement in imaging progression-free survival with the combination of Olaparib and Abiraterone compared to Abiraterone monotherapy [1] - Although the sample size of the Chinese cohort was small and interpretation was limited, the study data also indicated improvements consistent with global cohort trends, with no new safety issues identified [1] Group 2: Expert Commentary - Professor Ye Dingwei, a leading researcher of the PROpel study in China, emphasized that patients with BRCA mutation metastatic castration-resistant prostate cancer have poor prognoses and unmet clinical needs [1] - He stated that the PROpel study results allow for earlier use of Olaparib in treatment, improving patient outcomes and highlighting the potential of this innovative therapy to become a new treatment standard [1] Group 3: Company Strategy - Dr. He Jing, AstraZeneca's Global Senior Vice President and Head of Global R&D in China, expressed excitement over the PROpel study results and indicated that the company will continue to leverage both in-house research and external collaborations to enrich its pipeline for the benefit of more cancer patients [1]

智通财经4月20日电，恒瑞医药(600276.SH)公告称，公司收到国家药监局核准签发关于HRS-1167片的 《药物临床试验批准通知书》，同意开展临床试验。HRS-1167片为公司自主研发的PARP1小分子抑制 剂，属于第二代PARP抑制剂，对PARP1的选择性更高、亲和力更强。目前处于早期临床开发阶段，有 潜力作为单一疗法和联合疗法治疗更多患者。根据相关法律法规要求，药物在获得临床试验批准通知书 后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。 恒瑞医药：收到HRS-1167片临床试验批准通知书 ...