Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab (Tyvyt) and bevacizumab for the treatment of advanced microsatellite stability or mismatch repair proficient (MSS/pmMR) colorectal cancer (CRC) in patients who have previously received at least two lines of treatment.
Chidamide, a first-in-class subtype-selective histone deacetylase (HDAC) inhibitor developed by Chipscreen, has already been approved for three indications in China, including peripheral T-cell lymphoma, breast cancer, and diffuse large B-cell lymphoma. The drug is also registered in Taiwan for breast cancer treatment and in Japan for leukemia and peripheral T-cell lymphoma. Chidamide is currently under investigation in a global multi-center Phase III study for first-line melanoma, highlighting its potential in addressing various cancer types.- Flcube.com