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Chipscreen Bioscience's Epidaza (chidamide) Receives NMPA Approval for Breast Cancer Indication

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Chipscreen Bioscience's Epidaza (chidamide) Receives NMPA Approval for Breast Cancer Indication

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  • The approval follows P-III ACE study assessing chidamide + exemestane demonstrated PFS benefit and the includes Chidamide + aromatase inhibitor in postmenopausal patients with HR+- HER2- advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression
  • Chidamide (CS055/HBI-8000/tucidinostat) is an orally available low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes targeting subtype 1- 2- 3 of Class I and subtype 10 of Class IIb HDAC and has also received CFDA approval for recurrent and refractory peripheral T-cell lymphoma in Dec 2014  
  • Epidaza is currently being evaluated as monothx or in combination with chemotherapeutic/targeted agents for the treatment of various hematological tumors- solid cancers- and HIV in the United States- Japan- Korea- China- and Taiwan

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Pharmaworld


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