
Hinova (688302. SH) is an international and clinical-stage pharmaceutical company focusing on developing new therapeutics for cancers and metabolic syndromes through PROTAC and deuteration technology. We are committed to the discovery and development of innovative drugs with global interests that meet significant clinical needs.
Hinova Pharma has 4 core R&D platforms, which are the PROTAC Platform, Deuteration Platform, Novel Target Discovery and Validation Platform, and Translational Medical Technology Platform. We have submitted more than 300 PCT and national patents, with more than 110 patents granted in China and in the globe, such as the US, EU, and Japan. We have 8 innovative projects in the R&D stage and 1 product commercially available, and 2 National Major Projects of "Significant New Drugs Creation" awarded by the Ministry of Science and Technology of the People’s Republic of China. Hinova Pharma is led by a management team comprised of accomplished experts in both the biotechnology and pharmaceutical industries. Our core team members are mostly from the world's Top 500 pharmaceutical companies, with 2 national-level and several provincial-level experts.
Among our pipeline and programs:
✔ Deuterium AR inhibitor Deuterium Enzalutamide Soft Capsules (HC-1119): The new drug, Deuterium Enzalutamide Soft Capsules, was officially approved for marketing by the National Medical Products Administration (NMPA) of China at the end of May 2025, providing Chinese prostate cancer patients with a new treatment option. In December 2025, it was included in the National Medical Insurance Drug List (2025) through national medical insurance negotiations for the first time, and the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines recommended it as a full-line treatment option for mCRPC. On the basis of enriching the treatment layout for advanced prostate cancer, the company continues to expand the indications of its products, promoting the development of new indications for this drug, and combining it with Androgen Deprivation Therapy (ADT) for the treatment of high-risk biochemical recurrence (BCR) prostate cancer. It is mainly targeted at early-stage patients who have recurred after radical prostatectomy, effectively delaying disease progression and reducing the risk of distant metastasis. Currently, the Phase III clinical trial of Deuterium Enzalutamide Soft Capsules for high-risk biochemical recurrence (BCR) prostate cancer received the NMPA's Clinical Trial Approval Notice in July 2026.
✔ HP518 is China's first oral AR PROTAC drug candidate to enter the clinical phase. The application for its Phase I/II clinical trial in China for the treatment of metastatic castration-resistant prostate cancer (mCRPC) was approved by the National Medical Products Administration (NMPA) in November 2023, and the first subject was dosed in December 2023. The Phase I tolerability study in China has been completed, and the first subject was enrolled in the Phase II trial in China in December 2024. Currently, the Phase II enrollment has been completed. Additionally, the application for clinical trials of HP518 for the same indication was approved by the Food and Drug Administration (FDA) in January 2023. The Phase I clinical trial for the same indication in Australia has been completed, and the results of the Australian clinical study were presented at the American Society of Clinical Oncology Genitourinary Symposium (ASCO-GU) in January 2024 and at the 2024 ASCO Annual Meeting in the United States. In June 2024, HP518 was granted Fast Track designation by the FDA for the treatment of AR-positive triple-negative breast cancer. In November 2025, the Phase I/II clinical trial of HP518 tablets combined with anti-tumor drugs for the treatment of advanced prostate cancer was approved by the NMPA.
✔ HP537, the clinical trial application for HP537 for the treatment of hematologic malignancies was approved by the NMPA in February 2024 in China and approved by the FDA in July 2024.
✔ HP560, the clinical trial application for HP560 for the treatment of myelofibrosis was approved by the NMPA in July 2024 in China.