China’s FDA approves Chipscreen’s Epidaza

Chinese biotech firm Chipscreen Biosciences has received regulatory approval of Epidaza (chidamide), the world first orally-administrated and subtype-selective histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL) patients, from the Chinese Food and Drug Administration (CFDA).

Peripheral T-cell lymphomas (PTCL) is a set of rare and heterogeneous group of mature T- and natural killer (NK)-cell neoplasms associated with poor outcome. PTCL makes up 25% to 30% of all non-Hodgkin's lymphoma (NHL) cases in China, much higher than that seen in Western countries of 10% to 15%. The subtype distribution of PTCL is also significantly different between China and Western countries, in which extranodal NK/T-cell lymphoma, nasal type (ENKL), a subtype highly aggressive with very poor prognosis, to be the leading subtype in Chinese population.

"Chidamide is the first new molecular entity discovered and developed by Chipscreen scientists in China. The CFDA's decision to approval the world first orally-administrated selective HDACi for PTCLs is an important validation of the drug's therapeutic potential for this urgent medical need for Chinese PTCLs patients. The orally administrated chidamide not just will provide affordable innovative treatment for the Chinese patients whom otherwise have no option to obtain most up-to-dated new treatment beyond conventional chemotherapies, but also have great potential, based on its unique epigenetic mechanism of actions and existing knowledge from the field, to be easily combined with other treatment modalities in comprehensive control and management of cancer patients in fight against drug resistance and tumor recurrence," said Xian-Ping Lu, chief executive and chief scientific officer of Chipscreen Biosciences.