海创药业：口服PROTAC药物HP518片联合抗肿瘤药物治疗晚期前列腺癌获批临床试验

Core Viewpoint - Haichuang Pharmaceutical (688302.SH) has received approval from the National Medical Products Administration of China for clinical trials of HP518 tablets in combination with anti-tumor drugs for the treatment of advanced prostate cancer, marking a significant step in the development of innovative cancer therapies [1] Group 1: Clinical Trial Approval - The company has been granted a Clinical Trial Approval Notice for HP518 tablets to conduct Phase Ib/II clinical trials for advanced prostate cancer [1] - HP518 has also received approval for clinical trials in China, Australia, and the United States, with no similar products currently approved for market [1] Group 2: Drug Mechanism and Advantages - HP518 is composed of a target protein ligand, an E3 ligase ligand, and a linker, which induces the ubiquitination of the androgen receptor (AR) and relies on proteasomal degradation to deeply inhibit the AR signaling pathway, achieving anti-tumor effects [1] - As a new oral PROTAC drug, HP518 exhibits typical advantages such as catalytic activity, high selectivity, and good safety profile [1] Group 3: Efficacy and Potential - Preclinical studies have shown that HP518 has high degradation activity against both resistant AR mutants and wild-type AR proteins, demonstrating excellent anti-cancer activity against AR-dependent prostate cancer cells [1] - The drug is expected to address resistance issues caused by mutations in prostate cancer treatment, providing new therapeutic options for this patient population [1]