China-based biopharmaceutical company Hinova Pharmaceuticals (SHA: 688302) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) in China for its drug candidate HP518, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC). The androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug has already been approved for studies in Australia and the United States, marking a significant step in its global development.
Mechanism of Action and Clinical Progress
HP518 works by promoting the binding of AR and E3 ligase to form a ternary complex, leading to the ubiquitination of AR. This process leverages the intracellular ubiquitin proteasome system to achieve AR degradation, thereby reducing the protein expression level of AR in prostate cancer cells. By inhibiting the growth of AR-dependent prostate cancer cells, HP518 aims to treat prostate cancer effectively. An early clinical study assessing the drug is currently underway in Australia, with the dosage escalation stage of the study already completed, indicating positive progress in the clinical development phase.
Significance of NMPA Approval
The approval from the NMPA for HP518’s clinical trial in China is a significant milestone for Hinova Pharmaceuticals, as it allows the company to expand its clinical research efforts into the Chinese market. This approval also highlights the potential of HP518 as a novel treatment option for patients with mCRPC, a disease with limited treatment options and significant unmet medical needs.-Fineline Info & Tech
