Pomalidomide

Multiple myeloma is the second most common malignant tumor of the hematological system. Over the past decade, the iteration of immunomodulatory drugs has greatly improved the survival prognosis of patients. As a third-generation immunomodulator, pomalidomide inhibits the proliferation of hematological system tumor cells and induces apoptosis, while enhancing the immune activity of T cells and natural killer cells and inhibiting the release of pro-inflammatory cytokines. Clinically, it is mainly used for adult patients with relapsed/refractory multiple myeloma who have received at least two prior therapies (including lenalidomide and a proteasome inhibitor) and have progressive disease. It can also be used in combination therapy for Kaposi's sarcoma. Compared with the first two generations of products, its lower dosage and stronger activity effectively reduce the incidence of adverse reactions such as peripheral neurotoxicity.

The global market size of pomalidomide was approximately USD 3.8 billion in 2023. Driven by the year-on-year increase in the number of patients with multiple myeloma and the rising penetration rate of combination therapy regimens, the market size is expected to exceed USD 5 billion by 2028, with a compound annual growth rate maintained at 5.6%. The Chinese market is currently in a stage of rapid growth. In 2023, the sales at the terminal of public medical institutions exceeded RMB 900 million, an increase of more than 7 times compared with 2019. There are fewer than 10 enterprises with approved generic drugs, so the competitive landscape is relatively relaxed. As the centralized procurement policy gradually covers this variety, the market demand for its API and preparations will be further released.

The original developer of pomalidomide is Celgene, a subsidiary of Bristol-Myers Squibb, and the original brand name is Pomalyst. Its core compound patent in the United States expired in 2019, and the compound patent in China expired in 2023. The main dosage form of the original product is capsule, with specifications including 1mg, 2mg, 3mg and 4mg, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. At present, more than 15 pomalidomide APIs in China have obtained A-status registration numbers, all the approved preparations on the market are capsules, and multiple generic drugs have passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of pomalidomide, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the quality reference needs of pharmaceutical enterprises in the whole process of R&D, registration and production.