Our Innovative Products

Chidamide (Tucidinostat, Trade name: Epidaza®), a Class 1.1 innovative drug, is a novel molecular entity with global patent protection and the first marketed product developed independently by Chipscreen Biosciences. Chidamide is the first oral subtype-selective histone deacetylase (HDAC) inhibitor in the world and represents a major achievement of the national 863 and Significant New Drug Discovery programs.

• In December 2014, Chidamide was approved for the treatment of peripheral T-cell lymphoma by the CFDA (now NMPA), filling a gap in lymphoma therapy in China.
• In July 2017, Chidamide was included in China’s national medical insurance coverage, bringing its benefits to more patients.
• In November 2019, Chidamide was approved by the NMPA in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone receptor-positive, HER2-negative, recurrent, or progressive locally advanced or metastatic breast cancer previously treated with endocrine therapy. This approval made Chidamide the first epigenetic drug approved for solid tumor
• therapy in the world, following groundbreaking evidence that Chidamide can effectively prevent tumor resistance in combination with other targeted drugs.
• In April 2021, a new drug application for Chidamide in the treatment of peripheral T-cell lymphoma (PTCL), the second indication for Chidamide in Japan, was successfully submitted to the Pharmaceuticals and Medical Devices Agency (PMDA).
• On June 21, a marketing application for Chidamide in the treatment of adult T-cell leukemia (ATL) was accepted by the PMDA, marking the first time a Chinese-developed drug had ever been approved for marketing oversea.
• In Jun. 2021, Chidamide monotherapy to treat Adult T-cell Leukemia/Lymphoma (ATL) was approved for marketing in Japan. 
• In Dec. 2021, Chidamide monotherapy to treat Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) was approved for marketing in Japan, which was a new indication approved following ATL in Jun. 2021 in the country. 

Several clinical trials of Chidamide either alone or in combination with other anti-tumor drugs for the treatment of hematological tumors, solid tumor malignancies and human immunodeficiency virus (HIV) are now being run simultaneously in different countries and regions, such as the United States, Japan, China, and Taiwan (China).

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. 

• 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).