During National Cancer Prevention and Awareness Week, the Chinese Society of Clinical Oncology (CSCO) successfully held its 2025 Guidelines Conference and released its updated series of clinical guidelines. Chipscreen Biosciences’ self-developed innovative therapy, Epidaza® (Chidamide), received authoritative guideline recommendations for three indications—peripheral T-cell lymphoma (PTCL), breast cancer (BC), and diffuse large B-cell lymphoma (DLBCL)—as well as for combination therapy regimens in colorectal cancer (CRC).

01 DLBCL: First-time Grade I Recommendation with 1A Evidence

Diffuse large B-cell lymphoma (DLBCL) is the most common pathological subtype of non-Hodgkin lymphoma (NHL), with particularly poor prognosis in patients showing dual expression of MYC and BCL2 (DE-DLBCL). The key unmet need in first-line DLBCL treatment is to improve complete response (CR) rates. In April 2024, China’s National Medical Products Administration (NMPA) approved the Chidamide plus R-CHOP regimen for treatment-naïve DLBCL patients with MYC and BCL2 co-expression. This regimen is the first innovative strategy in nearly two decades to demonstrate a significant improvement in CR rates—11% higher than the R-CHOP control group—while reducing the risk of disease progression by 32%. Chidamide remains the only approved and nationally reimbursed oral innovative therapy for first-line DLBCL treatment. The Phase III DEB trial showed that the Chidamide plus R-CHOP regimen significantly improved complete response (CR) rates in DE-DLBCL patients compared with R-CHOP alone (73.0% vs. 61.8%, P=0.014), while also extending event-free survival (EFS) (24-month EFS: 58.9% vs. 46.2%, P=0.018). This therapeutic approach was previously selected as a Late-Breaking Abstract (LBA) for oral presentation at the 2024 ASCO Annual Meeting. Its current Grade I Recommendation with 1A evidence in the CSCO guidelines provides authoritative guidance for clinical practice.

02 PTCL: Eight Consecutive Years of Grade I Recommendation with 1A Evidence

In December 2014, Chidamide was approved in China for relapsed or refractory peripheral T-cell lymphoma (PTCL), addressing a critical unmet medical need in this patient population. Over a decade of extensive clinical use, Chidamide has become the “gold standard” for PTCL treatment, accumulating robust evidence for first-line therapy. It has maintained a Grade I Recommendation with 1A evidence in clinical guidelines for eight consecutive years. Currently, a Phase III clinical trial evaluating Chidamide as first-line treatment for PTCL patients with the T follicular helper (TFH) phenotype has received regulatory approval. The latest CSCO guidelines continue to recognize Chidamide as the only therapy with a Grade I recommendation and 1A evidence for the entire relapsed/refractory PTCL population, further cementing its status as the standard of care.

03 mCRC: Immunotherapy Breakthrough for Cold Tumors

With high incidence rates, MSS/pMMR metastatic colorectal cancer (mCRC) is a prototypical “cold tumor,” characterized by low responsiveness to immunotherapy and representing a major global clinical challenge. The CAPability-01 study, led by Sun Yat-sen University Cancer Center, evaluated Chidamide in combination with bevacizumab and a PD-1 antibody for metastatic colorectal cancer and was published in the prestigious journal called Nature Medicine (IF = 82.9). Thanks to its promising clinical benefits, the CAP regimen has been consecutively included in MSS/pMMR mCRC treatment guidelines for two years. Its Phase III trial is currently progressing smoothly across multiple centers nationwide and has been designated a “Breakthrough Therapy” by the Center for Drug Evaluation.

04 BC: Delivering Novel Epigenetic-Immunotherapy Mechanisms

Chidamide's indication for advanced breast cancer has received a Category II recommendation in the 2025 edition of the CSCO Breast Cancer Diagnosis and Treatment Guidelines, with Class 1B evidence supporting its combination with AI/SAI in HR+ metastatic breast cancer (MBC) and Class 2A evidence for patients with disease progression after CDK4/6 inhibitor therapy. The Phase III ACE registration trial demonstrated that Chidamide provides significant clinical benefit for hormone receptor-positive (HR+) breast cancer patients. Recent studies further highlight its therapeutic potential in populations resistant to CDK4/6 inhibitors. With ongoing clinical research and expanding indications, Chidamide is expected to offer benefits to an increasing number of patients with solid tumors in the future.