Selinexor

In response to the unmet clinical needs for hematological malignancies such as relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma, the advent of selective inhibitor of nuclear export (SINE) drugs has brought new treatment options for patients who have failed multi-line therapy. As the first SINE drug approved worldwide, selinexor specifically inhibits the nuclear export protein XPO1, promoting the retention and activation of tumor suppressor proteins in the nucleus, while reducing the translational expression of oncoproteins, thereby inducing tumor cell apoptosis. It has been approved for use in combination regimens for the treatment of relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma, and has also been included in relevant clinical guidelines as a recommended treatment for hematological malignancy patients who have received prior multi-line therapy.

The global selinexor market size exceeded US$330 million in 2022, and the compound annual growth rate from 2023 to 2029 is expected to remain at around 12%. The growth drivers mainly come from the expansion of hematological malignancy indications and clinical exploration in the field of solid tumors. Currently, the global market is still dominated by the original research product. In the Chinese market, since the approval of the original research product for marketing in 2021, the demand has been increasing year by year. At present, a number of domestic pharmaceutical companies have deployed generic drug R&D. With the expiration of core patents one after another, the subsequent launch of generic drugs is expected to further improve drug accessibility.

The original research enterprise of selinexor is Karyopharm Therapeutics, and the original brand name is Xpovio (Anxianke). Its core compound patent in the United States expires in 2037, and the Chinese compound patent expires in 2028. The dosage form approved for the original product is tablet, with specifications including 20mg, 50mg and 80mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Collection of Chemical Drugs* of China. In terms of domestic API registration, a number of enterprises have obtained CDE registration numbers for selinexor APIs at present, and the original preparation and a number of domestic generic 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 selinexor impurity reference standards, which can cover the impurity reference substance needs in the whole process of drug R&D, quality research and registration declaration. Most 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 Chinese Pharmacopoeia and FDA, which can effectively help pharmaceutical companies shorten the R&D cycle and ensure the standardization and reliability of quality research data.