BioTianfu R&D | Hinova's PROTAC Oral Drug HP518 Was Approved by the NMPA for Clinical Trials, Creating a Blue Ocean after Australia and the United States

Date:2023-11-03 Views:1052

       Hinova, an enterprise in Tianfu Life Science Park, has brought about good news frequently. Its deutenzalutamide HC-1119-04 registered study has been included in the 2023 edition of CSCO guidelines for the diagnosis and treatment of prostate cancer. Recently, we have received the latest news from the enterprise.

       Hinova's PROTAC Drug HP518 Was Approved by the NMPA for Clinical Trials

       Recently, the Center for Drug Evaluation of the National Medical Products Administration of China officially issued the Notice on the Approval of Drug Clinical Trials, approving Hinova's clinical trials on HP518 for the treatment of "metastatic castration-resistant prostate cancer (mCRPC)". So far, no similar products have been approved or launched at home and abroad.

       HP518 is an androgen receptor (AR) PROTAC drug independently developed by the company based on the proteolysis-targeting chimera (PROTAC) core technology platform, which is intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC). HP518 is a new type of PROTAC oral drug. The results of preclinical studies have shown that HP518 has high degradation activity against drug-resistant AR mutants and wild-type AR proteins and excellent inhibition activity against AR-dependent prostate cancer cells. It is expected to overcome the problem of drug resistance caused by mutations in the treatment of prostate cancer and provide new treatment methods for the corresponding patient group.

       The first patient of HP518 was enrolled in Australia at the beginning of 2022. Dose-escalation trials on multiple dose groups have been completed, and the work is progressing smoothly as planned now. Besides, the clinical trial application for this innovative drug has been approved by the U.S. Food and Drug Administration (FDA) in 2023.

       The company will continue to invest resources in clinical trials on HP518 to ensure the product's safety and efficacy, hoping that the innovative drug can eventually offer better treatment options to patients worldwide. With further research and development, HP518 is expected to be a significant breakthrough in the treatment of prostate cancer, thus improving the patient's quality of life.

       Hinova (688302. SH) is a global innovative drug company focusing on cancers and metabolic syndromes. With the mission of "developing good drugs and benefiting the world", it focuses on providing safe, effective, and affordable drugs for patients and is committed to the R&D and production of innovative drugs with global interests that meet significant clinical needs.


  • Phase One

    Tel:028-85975146

    Add:No. 88, Keyuan South Road, High-tech Zone, Chengdu

  • Phase Two

    Tel:028-85326166

    Add:No. 2222, Xinchuan Road, High-tech Zone, Chengdu

  • Phase Three

    Tel:028-58976074

    Add:No. 2222, Xinchuan Road, High-tech Zone, Chengdu

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