2026-01-12 Written by DengyueMed

As cancer treatment evolves from traditional chemotherapy to more precise targeted and immune-based therapies, scientists have discovered a new and powerful approach—epigenetic therapy. One of the most important breakthroughs in this field is chidamide (brand name: Epidaza®), a pioneering anticancer drug developed in China.

Chidamide is not only the first original chemical anticancer drug approved in China, but also the world’s first subtype-selective histone deacetylase (HDAC) inhibitor. Since its approval, it has brought new hope to patients with several difficult-to-treat cancers, including lymphomas and breast cancer, and has become a landmark achievement in China’s biomedical innovation.

How Does Chidamide Work?

Our genes control how cells grow, divide, and die. While the DNA sequence itself usually does not change, the way genes are “turned on or off” can be altered. This process is known as epigenetic regulation.

In many cancers, abnormal epigenetic changes silence genes that normally suppress tumors. One key player in this process is a group of enzymes called histone deacetylases (HDACs). When HDACs are overactive, cancer cells gain a survival advantage.

Chidamide works by selectively blocking specific HDAC subtypes, helping to restore normal gene activity. This allows tumor-suppressing genes to function again, slowing cancer cell growth and triggering cancer cell death.

Even more importantly, chidamide can improve the body’s immune response against cancer. By reshaping the tumor immune environment, it helps immune cells better recognize and attack cancer cells. This dual effect—directly targeting cancer cells while supporting immune defense—makes chidamide especially promising, both alone and in combination with immunotherapy.

Which Cancers Can Chidamide Treat?

Since its first approval in 2014, chidamide has been gradually approved for multiple cancer types, particularly those with limited treatment options.

Peripheral T-Cell Lymphoma (PTCL)

PTCL is a rare and aggressive type of blood cancer with poor outcomes and few effective treatments. In 2014, chidamide was approved in China for patients with relapsed or refractory PTCL who had already received chemotherapy.

Over the past decade, extensive clinical use has shown that chidamide can provide meaningful benefit for these patients. It has been consistently recommended as a standard treatment option in Chinese clinical guidelines and was later approved in Japan, expanding its global impact.

Breast Cancer

In 2019, chidamide was approved in China for use in combination with hormone therapy to treat postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer whose disease no longer responded to standard endocrine treatments.

Clinical studies showed that adding chidamide could help overcome hormone resistance and delay disease progression, offering a new option for patients who had limited choices before.

Diffuse Large B-Cell Lymphoma (DLBCL)

DLBCL is the most common type of lymphoma. Some patients have a particularly aggressive form known as MYC/BCL2 double-expressor DLBCL, which responds poorly to standard chemotherapy.

In 2024, chidamide combined with standard chemotherapy was approved in China for newly diagnosed patients with this high-risk subtype. Clinical trials showed that the combination significantly improved complete remission rates and reduced the risk of disease progression—representing a major advance after nearly 20 years without meaningful progress for this patient group.

Adult T-Cell Leukemia (ATL)

Chidamide has also been approved in Japan for patients with relapsed or refractory adult T-cell leukemia, further expanding its role in blood cancer treatment.

Is Chidamide Safe?

Like most cancer treatments, chidamide can cause side effects, but overall its safety profile is well understood and manageable.

Common side effects include low blood cell counts, fatigue, and mild digestive symptoms. Doctors closely monitor patients during treatment and can adjust the dose if needed. Large clinical studies have shown that chidamide can be used safely, both alone and in combination with other therapies.

New Hope Through Combination Therapy

One of the most exciting areas of research is combining chidamide with immunotherapy. Studies suggest that chidamide can “wake up” tumors that do not normally respond to immune treatments.

In advanced colorectal cancer—a type often resistant to immunotherapy—chidamide combined with immune and targeted drugs has shown encouraging results in clinical trials, giving new hope to patients with so-called “cold tumors.”

Researchers are also studying chidamide in lung cancer, melanoma, and other cancers, with several international clinical trials currently underway.

Looking Ahead

Chidamide represents more than a single new drug—it reflects a shift in cancer treatment and a major step forward for China’s pharmaceutical innovation.

By targeting cancer at the epigenetic level and working hand in hand with the immune system, chidamide is opening new paths in cancer therapy. As research continues, it is expected to benefit more patients and play an increasingly important role in the global fight against cancer.