Carfilzomib

The treatment of multiple myeloma has entered a targeted era dominated by proteasome inhibitors. As a second-generation epoxyketone proteasome inhibitor, carfilzomib can bind to the chymotrypsin-like active subunit of the 20S proteasome with high selectivity and irreversibility, block the protein degradation mediated by the ubiquitin-proteasome pathway, and induce apoptosis of myeloma cells. Compared with the first-generation products, it has lower neurotoxicity and higher depth of remission. It is mainly used for adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, and can also be combined with immunomodulators and dexamethasone for first-line treatment of patients who are not suitable for autologous hematopoietic stem cell transplantation, significantly prolonging the progression-free survival and overall survival of patients.

The global market size of carfilzomib was approximately USD 1.9 billion in 2023. Driven by the increasing prevalence of multiple myeloma year by year and the forward shift of treatment lines, it is expected to reach USD 2.6 billion by 2028, with a compound annual growth rate of approximately 6.4%. At present, the original research product still occupies the major market share in the world. The Chinese market has not yet entered the stage of high-volume launch, only 3 domestic enterprises have obtained approval for generic preparations, and the domestic supply of API is still in the early layout stage and has not been included in the national centralized volume procurement catalog, so there is large substitution space in the market.

The original research enterprise of carfilzomib is Onyx Pharmaceuticals (later acquired by Amgen), and the original research trade name is Kyprolis®. The core compound patent expires in China in 2027. The dosage form approved for the original research product is injection, with specifications including 10mg, 30mg and 60mg. It has been included in the China Listed Drug Catalogue and is the reference preparation for domestic generic drug research and development. Up to now, the original research carfilzomib preparation has been approved for marketing in China. There is no domestic registration number in status A on the CDE API registration platform, and only the API registration numbers of 3 enterprises are in status I. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of carfilzomib impurity reference standards, which fully cover dozens of categories such as synthetic process intermediates and degradation impurities. Most products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the quality compliance requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the whole process of API research and development, quality research and declaration.