Chiauranib

Chiauranib

Due to tumor heterogeneity, drug resistance to targeted therapy is a common issue afflicting agents that target a single pathway.

 

Chiauranib, a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor, was developed by Chipscreen Biosciences 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 June 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 December 2020, Chiauranib was included in the “Breakthrough Therapy Category” for the treatment of small cell lung cancer by the Center for Drug Evaluation (CDE) of NMPA.
  • In March 2021, Chiauranib was included in the “Breakthrough Therapy Category” for the treatment of ovarian cancer by the CDE of NMPA.
  • In March 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 April 2021, an application for a pivotal Phase III clinical trial of Chiauranib in the treatment of ovarian cancer was approved by the NMPA.
  • In April 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 May 2021, an application for the Phase II clinical trial of Chiauranib for triple-negative breast cancer was accepted by the NMPA.
  • In Apr. 2021, the application for the pivotal phase III clinical trial of Chiauranib for the treatment of ovarian cancer was approved by the National Medical Products Administration (NMPA). 
  • In Apr. 2021, the Investigational New Drug (IND) application for the phase Ib/II clinical trial of Chiauranib to treat Small Cell Lung Cancer (SCLC), an application for the first indication of Chiauranib in the US, was approved by the U.S. Food and Drug Administration (FDA). 
  • 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).