Chiauranib is a novel molecular entity independently designed and developed by the company, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug.
Chiauranib, a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor, was developed by Chipscreen Biosesciences specifically to address drug resistance.Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. With a favorable safety profile, Chiauranib has outperformed drugs with a similar mechanism in its pharmacodynamic activity in animal studies.
Figure. Triple-pathway anti-tumor mechanisms of Chiauranib
- In Jun. 2018, approvals for Phase II/III clinical trials of Chiauranib were granted by the CFDA. Phase II clinical trials of the drug for a variety of tumors have now been completed.
- In Dec. 2020, Chiauranib was included in the “Breakthrough Therapy Category” for the treatment of small cell lung cancer by the Center for Drug evalsuation (CDE) of NMPA.
- In Mar. 2021, Chiauranib was included in the “Breakthrough Therapy Category” for the treatment of ovarian cancer by the CDE of NMPA.
- In Mar. 2021, an application for a pivotal Phase III clinical trial of Chiauranib in the treatment of small cell lung cancer was approved by the NMPA.
- In Apr. 2021, an application for a pivotal Phase III clinical trial of Chiauranib in the treatment of ovarian cancer was approved by the NMPA.
- In Apr. 2021, an investigational new drug (IND) application for a Phase Ib/II clinical trial of Chiauranib was approved by the FDA, the first approved trial indication for Chiauranib in the U.S.
- In Jul. 2021, the application for the phase II clinical trial of Chiauranib in the treatment of Triple Negative Breast Cancer was approved by the National Medical Products Administration (NMPA).
- In Sep. 2021, Chiauranib was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) to treat Small Cell Lung Cancer (SCLC).
- In Sep. 2023, the enrollment in the phase III clinical trial of chiauranib monotherapy of small cell lung cancer was completed.
- The database for the phase III clinical trial of Chiauranib monotherapy for small cell lung cancer was locked in Apr. 2024. The pre-NDA communication materials are scheduled for submission to the CDE.
- In Jun. 2024, 9 patients have been enrolled in the phase II clinical trial of Chiauranib monotherapy or combination therapy in patients with advanced triple-negative breast cancer who have failed anthracycline and paclitaxel-based treatments.
- In Jun. 2024, the application for a phase II clinical trial of Chiauranib combined with albumin-bound paclitaxel and gemcitabine as a first-line treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma was approved by the China Medical Products Administration (NMPA).
- For a phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer/solid tumors in the United States, the initiation of 12 clinical study sites has been completed as planned.
- In Jul. 2024, over 2/3 of the patients have been enrolled in the phase III clinical trial of Chiauranib combined with chemotherapy in the treatment of ovarian cancer.