On July 23, 2024, Shenzhen Chipscreen Biosciences Co., Ltd. (“Chipscreen Biosciences,” stock code: 688321.SH) received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical trial of its Class I innovative anti-tumor drug, Chidamide, in combination with Sintilimab and Bevacizumab for the treatment of colorectal cancer (CRC). This randomized, open-label, controlled, multicenter study will evaluate the efficacy and safety of Chidamide combined with Sintilimab and Bevacizumab in patients with advanced microsatellite stable or mismatch repair–proficient (MSS/pMMR) colorectal cancer who have failed two or more prior lines of standard therapy.

Earlier, on June 8, Chidamide was officially designated a “Breakthrough Therapy” by the Center for Drug Evaluation (CDE) of the NMPA for the proposed indication of Chidamide in combination with Sintilimab and Bevacizumab in advanced MSS/pMMR CRC patients who have exhausted ≥2 prior standard treatments.

According to the latest data from the National Cancer Center, colorectal cancer ranks second in incidence and fourth in mortality among all malignancies in China. Among patients with advanced CRC, more than 90% have microsatellite stable/mismatch repair–proficient (MSS/pMMR) tumors, which do not respond to immunotherapy alone, highlighting a significant unmet clinical need.

Results from a Phase II clinical trial showed that for MSS/pMMR metastatic colorectal cancer (mCRC) patients, the triple-drug regimen of Chidamide + Sintilimab + Bevacizumab as third-line or later therapy achieved an 18-week progression-free survival (PFS) rate of 64.0%, an objective response rate (ORR) of 44.0%, and a median PFS of 7.3 months, establishing it as a highly promising option for this patient population.

Dr. Lu Xianping, founder and chairman of Chipscreen Biosciences, commented: “The NMPA approval for the Phase III clinical trial of Chidamide triple therapy marks a major milestone in our oncology development program Chidamide’s unique mechanism of action not only highlights the tremendous potential of combining epigenetics with tumor immunotherapy but also offers novel strategies for future cancer immunotherapy. Our R&D team is accelerating its clinical development program.”