On April 16, the CDE official website showed,HuiRui「Talazoparib Tosylate Capsules"New Indication Marketing Application Accepted"Based on the registration classification and clinical trial progress, the Insight database speculates that the indication for this application is HER2-negative breast cancer with germline BRCA mutations.Last November, the product was approved for marketing in China.Combined with Enzalutamide for Metastatic Castration-Resistant Prostate Cancer with HRR Gene Mutations(mCRPC) Adult Patients。Source: CDE Official WebsiteTalazoparib is a poly (ADP-ribose) polymerase(PARP, including PARP1 and PARP2)Inhibitor,With dual mechanisms of action in inhibiting PARP enzyme and PARP trapping。
In October 2018, Talazoparib was first approved for marketing in the United States for the treatment of patients with harmful or suspected harmful germline BRCA mutations.（gBRCAm）Adult patients with HER2-negative locally advanced or metastatic breast cancer. In June 2023, the new indication for this product was approved by the FDA, in combination with enzalutamide.Combined Use for mCRPC with HRR Gene MutationsPatient.PARP inhibitors are the first drugs to achieve success based on the concept of synthetic lethality.Currently, 6 products have been approved in China.. ExceptIn addition to Talazoparib, there areOlaparib (AstraZeneca), Pamiparib (BeiGene), Niraparib (Zai Lab), Fluzoparib (Hengrui Medicine)) andSenaparib (InnoPharma).According to the sales data section of the Insight database annual report, Olaparib is the best-selling PARP inhibitor, with sales reaching $3.072 billion in 2024.Talazoparib generated $117 million in revenue last year.Cover Source:Corporate LogoDisclaimer:This article is for information sharing only,不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。
Editor: Crescent Moon
PR Article Coordination: WeChat insightxb
SubmissionWeChat: insightxb; Email: insight@dxy.cn
'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)