Lenalidomide

Multiple myeloma, as the second most common hematological malignancy, has long been faced with the dilemmas of high recurrence rate and prominent drug resistance in clinical treatment. The advent of lenalidomide has brought the possibility of long-term survival for such patients. As a second-generation immunomodulatory anti-tumor drug, it exerts effects through multiple mechanisms: on the one hand, it inhibits the proliferation of tumor cells and induces apoptosis; on the other hand, it regulates immune function and blocks tumor angiogenesis. At present, it is not only the core drug for the first-line treatment of multiple myeloma, but also can be used for the treatment of myelodysplastic syndrome, mantle cell lymphoma and other diseases, covering adult patient groups in all stages of newly diagnosed, relapsed/refractory and maintenance treatment.

The global market size of lenalidomide once peaked at nearly USD 13 billion. With the expiration of core patents, the rapid entry of generic drugs has driven significant changes in the market structure. In 2023, the sales of lenalidomide at the terminal of Chinese public medical institutions exceeded RMB 3 billion, with a compound annual growth rate of more than 12% in the past three years. At present, the domestic market has formed a pattern where the original drug and generic drugs from multiple manufacturers coexist. More than 20 enterprises have obtained approval for the marketing of lenalidomide preparations, and this product has been included in multiple rounds of national centralized drug procurement. The winning bid price has dropped by more than 90% compared with the initial marketing stage of the original drug, and the accessibility for patients has been greatly improved.

The original developer of lenalidomide is Celgene Corporation of the United States (now part of Bristol-Myers Squibb), and the brand name of the original drug is Revlimid. Its core compound patent expires in 2027 in the United States, while the core patent in China expired in 2024. The main dosage form approved for the original drug is capsule, with specifications including 5mg, 10mg, 15mg and 25mg. It has been included in the Catalogue of Marketed Drugs in China as a reference preparation, and is also included in the FDA Reference Listed Drug Directory. At present, lenalidomide APIs from more than 30 domestic enterprises have completed registration (Status A) at the CDE, and the original drug as well as a number of domestic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for lenalidomide API, and most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in drug research and development, quality control and consistency evaluation.