The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd’s (SHA: 688321) Epidaza (chidamide) has been granted priority status for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin, vincristine, and prednisone). The new indication filing is supported by the results of a randomized, double-blind, placebo-controlled, multi-center Phase III study, which showed complete response rate (CRR) and event-free survival (EFS) outcomes that meet conditional approval criteria.
Chipscreen’s Chidamide: A First-In-Class Histone Deacetylase Inhibitor
Chipscreen’s chidamide is a first-in-class subtype-selective histone deacetylase inhibitor that has been available in China since December 2014 for the treatment of the rare disease peripheral T-cell lymphoma. In November 2019, a second indication was approved for use in combination with hormonal therapy for previously treated ER+/HER2- advanced breast cancer. The drug has also received approval in Japan for the treatment of adult T-cell leukemia (ATL) and peripheral T-cell lymphoma (PTCL).
Licensing and Global Expansion
In 2013, Chipscreen licensed the rights to the molecule to GNT Biotech & Medicals Corporation in Taiwan, where it was approved in March this year for the treatment of postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor-positive and human epidermal growth factor receptor II (HER2) negative, and have relapsed or deteriorated after endocrine therapy combined with exemestane.-Fineline Info & Tech
