Shenzhen Chipscreen Pharmaceutical Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for the treatment of advanced microsatellite stable or mismatched repair proficient (MSS/pMMR) colorectal cancer in the third-line or later setting.
Chidamide, a first-in-class subtype-selective histone deacetylase inhibitor developed by Chipscreen, has been commercially available in China for the treatment of peripheral T-cell lymphoma, a rare disease, since December 2014. The drug has also received indication approvals for breast cancer and diffuse large B-cell lymphoma. Internationally, chidamide is registered in Japan for leukemia and peripheral T-cell lymphoma and in Taiwan for breast cancer.- Flcube.com
