Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen.
Indication and Target Patient Group
The Category 1 drug is approved for use in treating postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor-positive and human epidermal growth factor receptor II (HER2) negative, and who have relapsed or deteriorated after endocrine therapy combined with exemestane.
Background and Previous Approvals
Chipscreen’s chidamide is a first-in-class subtype-selective histone deacetylase inhibitor. It has been on the market in China since December 2014 as a treatment for the rare disease peripheral T-cell lymphoma. A second indication approval was awarded in November 2019 for use in combination with hormonal therapy in previously treated ER+/HER2- advanced breast cancer. The drug has also been approved in Japan to treat adult T-cell leukemia (ATL) and peripheral T-cell lymphoma (PTCL). Chipscreen granted Taiwan rights to the molecule to GNT via a licensing deal in 2013.
Significance of the Approval
The TFDA approval of Epidaza in Taiwan expands the drug’s market reach and underscores its potential as a treatment option for patients with advanced breast cancer. This development highlights Chipscreen Pharmaceutical’s ongoing commitment to bringing innovative therapies to patients globally.-Fineline Info & Tech
