Latest progress on inclusion of Enasidenib in medical insurance in 2025

Enasidenib is an oral inhibitor targeting isocitrate dehydrogenase 2 (IDH2) mutations and is mainly used to treat relapsed or refractory acute myeloid leukemia (AML) in adults. As one of the important representative drugs in the era of precision medicine, its development was jointly promoted by the American company Agios and Celgene, and has been approved for marketing by the US FDA. Although this drug has been used in European and American countries for many years, as of 2025, it has not been officially approved for marketing in mainland China, and therefore has not yet entered the national medical insurance directory.

Currently, conventional chemotherapy and hematopoietic stem cell transplantation are the main treatments for IDH2-mutant AML in China. As the demand for targeted therapies increases, domestic drug regulatory agencies are actively evaluating the feasibility of introducing relevant innovative drugs. According to the latest policy trends, adjustments to China's medical insurance catalog are increasingly inclined to include innovative anti-tumor drugs, especially for rare mutations or diseases that are difficult to treat. If ensidipine is successfully approved for marketing in China in the future, its medical insurance inclusion process may follow the path of other IDH targeted drugs, that is, after the clinical value and economic evaluation is completed, it will be included in the medical insurance directory through negotiation.

Overseas studies have shown that ensidipine has high tolerability and durable efficacy in patients with IDH2-mutated AML. Its non-cytotoxic mechanism of action is also considered an important breakthrough in the treatment of relapsed AML. With the popularization of domestic molecular testing and the in-depth promotion of treatment concepts, ensidipine is expected to become an important supplementary option for precision treatment of AML in the future.

At present, some domestic clinical institutions have applied for clinical research projects on ensidipine, which means that its entry into the Chinese market is gradually advancing. If the approval goes smoothly, it may become a key node for the drug to be launched in China, and medical insurance negotiations will also become a policy focus.

Reference materials:https://www.idhifa.com/