China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step forward in the clinical development of Epidaza for this specific indication.
Chidamide: First-in-Class Histone Deacetylase Inhibitor
Chipscreen’s chidamide is a first-in-class subtype-selective histone deacetylase inhibitor that has received three indication approvals in China for peripheral T-cell lymphoma, breast cancer, and diffuse large B-cell lymphoma. The drug is also registered in Taiwan for the treatment of breast cancer and in Japan for use in leukemia and peripheral T-cell lymphoma. Multiple studies for the drug are currently underway, including a global multi-center Phase III study in first-line melanoma.
Future Development and Clinical Trials
With the NMPA’s approval, Chipscreen Biosciences is poised to advance the clinical development of Epidaza. The Phase III study will provide valuable data on the efficacy and safety of Epidaza in combination with CHOP for the treatment of PTCL-TFH. This development underscores Chipscreen’s commitment to advancing innovative therapies for patients with unmet medical needs in oncology.-Fineline Info & Tech
