Ubenimex

Immune dysfunction is a common clinical challenge for tumor patients during treatment, and the emergence of immunomodulatory adjuvant drugs provides an important approach to improve this situation. Ubenimex is a dipeptide immunomodulator that can competitively inhibit the activities of aminopeptidase N and leucine aminopeptidase. On the one hand, it can enhance the killing function of T cells and NK cells, promote the synthesis of colony stimulating factors and thus stimulate the regeneration of bone marrow cells; on the other hand, it can interfere with the metabolism of tumor cells, inhibit the proliferation of tumor cells and induce their apoptosis. Clinically, it is mainly used for adjuvant therapy in combination with radiotherapy and chemotherapy, and for the improvement of immune function deficiency in the elderly. It can also be used in the treatment of diseases such as multiple myeloma, myelodysplastic syndrome and hematopoietic stem cell transplantation, covering patient groups of all ages who meet the indications.

The domestic market size of ubenimex maintains a steady growth trend. In 2023, the overall market size exceeded 1.2 billion yuan, and the compound annual growth rate in the past five years has remained at around 7%. In terms of the competitive landscape, the original research product still accounts for about 35% of the market share, and domestic generic drugs have gradually increased their market share relying on their cost-effectiveness advantages. At present, more than 10 domestic enterprises have obtained the production approval of preparations, and the API manufacturers are mainly local manufacturers, with relatively sufficient overall supply and no relevant records of large-scale centralized procurement implementation so far.

The original research enterprise of ubenimex is Nippon Kayaku Co., Ltd., and the original brand name is "Bai Shi Xin". Its core compound patent expired in 2018. The mainstream dosage form of the original research product is capsule with a specification of 10mg, which has been included in the *Catalogue of Listed Drugs in China* as the reference listed drug. In terms of domestic API registration, at present, ubenimex APIs from a number of local enterprises have obtained CDE registration numbers with the status of A (approved for use in marketed preparations), and the domestically approved preparation varieties cover two categories: capsules and tablets. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for ubenimex API, and most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide reliable reference standard support for pharmaceutical enterprises in API R&D, quality control and declaration work.