Singapore: A Chinese biotech firm, Chipscreen Biosciencees has received the China FDA nod for its flagship drug Epidaza (chidamide), the world first orally-administrated and subtype-selective histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL) patients.

PTCL is a rare disorder, which makes up for 30 percent of all non-Hodgkin's lymphoma (NHL) cases in China. 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 approve Chidamide for PTCLs, is an important validation of the drug's therapeutic potential to solve this urgent unmet medical need.

"Chidamide will offer an affordable and innovative solution for Chinese patients beyond conventional chemotherapies, and also has a great potential 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 Mr Xian-Ping Lu, chief executive and chief scientific officer of Chipscreen Biosciences.