氘恩扎鲁胺(海纳安)
Search documents
海创药业HP518片临床研究有序推进 构建前列腺癌全链条治疗生态
Zheng Quan Ri Bao Wang· 2025-11-25 10:11
Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration of China for its new generation androgen receptor (AR) targeted protein degrader HP518 tablets, which will be used in a Phase Ib/II clinical trial for advanced prostate cancer treatment [1] Group 1: Product Development - HP518 tablets offer a more efficient mechanism to block the AR pathway compared to traditional AR inhibitors, providing a core solution for next-generation treatment options for prostate cancer patients [1] - The Phase I clinical studies for HP518 have been completed in Australia and China, and the Phase II clinical trial in China has successfully enrolled all participants [1] Group 2: Market Positioning - HP518 tablets are positioned alongside Haichuang's commercially successful second-generation AR inhibitor, Dihydrotestosterone Enzalutamide (Hainan An), creating a differentiated combination matrix where HP518 focuses on AR degradation while Hainan An targets AR signal blockade [1] - Dihydrotestosterone Enzalutamide soft capsules are the first domestically approved innovative drug for this indication, demonstrating superior safety by significantly reducing the incidence of central nervous system adverse events and common complications in elderly patients [1] Group 3: Market Potential - The drug is expected to benefit more prostate cancer patients once it enters the medical insurance system, with projections indicating that the prostate cancer market in China could reach 50 billion yuan by 2030 [1]