Company Profi
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 9 innovative projects in the R&D stage, 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:
✔ Deutenzalutamide (HC-1119), for the treatment of castration-resistant prostate cancer (mCRPC) has entered the global multicenter Phase III clinical trials and the Phase III clinical trial in Chinese Patients with mCRPC have met the primary endpoint, the NDA application of HC-1119 was accepted by NMPA in November 2023; the Chinese Phase III clinical trial in Chinese Patients with mCRPC of HC-1119, an AR antagonist, have met the primary endpoint. Its Phase III clinical trial data were accepted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting in June 2023. Information from the registration study (HC-1119-04) of HC-1119 was included in the 2023 edition of the Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Diagnosis and Treatment Guidelines. The new drug application for HC-1119 was accepted by the National Medical Products Administration (NMPA) in November 2023 in China.
✔ HP501, for the treatment of hyperuricemia and gout, has been studied in several phase I/II trials as a single agent; and it's IND application has been approved by the FDA for the Phase II clinical trial; The IND application of HP501 as combined therapy (with febuxostat) in China was approved by the NMPA in April 2024.
✔ HP518, an orally bioavailable chimeric degrader targeting AR, Phase I clinical trials of HP518 for the treatment of mCRPC in Australia have been completed. The clinical research results from Australia were accepted for presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) in January 2024 and were also accepted for the 2024 ASCO Annual Meeting. and it's IND application has been approved by the FDA and the NMPA. The Chinese clinical trial application was approved by the NMPA in November 2023, and the FPI was completed in December 2023. FDA has granted Fast Track designation for HP518 for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC).
✔ 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.
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