Decitabine

Myelodysplastic syndrome (MDS) is a group of heterogeneous myeloid clonal diseases originating from hematopoietic stem cells. Patients often face the dilemmas of ineffective hematopoiesis and high risk of transformation to acute myeloid leukemia, and there has been a long-term lack of targeted treatment regimens with high efficacy and low toxicity in clinical practice. As a pyrimidine nucleoside analog hypomethylating agent, decitabine can reverse the methylation silencing status of tumor suppressor genes in tumor cells and restore their normal expression by inhibiting DNA methyltransferase, thereby inducing the differentiation and apoptosis of tumor cells. At present, this drug has been recommended as the first-line treatment for MDS by multiple clinical guidelines, and can also be used for the treatment of elderly patients with acute myeloid leukemia, providing a new treatment option especially for elderly patients who cannot tolerate intensive chemotherapy.

The global market size of decitabine has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 420 million, with China's market accounting for more than 35% and the growth rate higher than the global average. In terms of the competitive landscape, the market share of the original research product has dropped from 85% before patent expiration to 21% in 2023, and domestic generic drugs have become the mainstream of the market. At present, more than 15 domestic enterprises have obtained the production approval documents for decitabine preparations, and this variety has been included in multiple rounds of national centralized procurement. The winning bid price has dropped by more than 90% compared with the peak price of the original research product, and the accessibility for patients has been greatly improved.

The original research enterprise of decitabine is Johnson & Johnson in the United States, and the original research trade name is Dacogen®. Its core compound patent in the United States expired in 2013, and the core patent in China expired in 2015. The main dosage form approved for the original research product is injection, with a specification of 50 mg per vial, which has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. At present, there are more than 20 marketing authorization numbers for decitabine active pharmaceutical ingredients (APIs) in China, most of which are in A status and can be marketed and sold domestically, and multiple domestic varieties of corresponding preparations have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of decitabine impurity reference standards. The products strictly comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock all year round. Orders placed before 16:00 can be shipped on the same day, which can fully meet the needs of API manufacturers and R&D institutions for impurity research and quality control.