Ixazomib

The treatment of multiple myeloma has long relied on injectable proteasome inhibitors, and the problem of limited out-of-hospital compliance of patients is prominent. The advent of ixazomib has filled the clinical gap of oral dosage forms. As the world's first oral reversible proteasome inhibitor, it selectively binds to the β5 subunit of the 20S proteasome, inhibits proteasome activity, and induces tumor cell apoptosis. It is often combined with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one line of prior therapy. The advantage of convenient administration greatly reduces the burden of patients traveling to and from medical institutions, and also provides a better option for long-term maintenance treatment regimens.

At present, the global market size of ixazomib is stable at more than US$1 billion. Driven by the逐年 rising incidence of multiple myeloma and the increasing clinical penetration rate of oral dosage forms, the compound annual growth rate in the past 3 years has remained at about 5%. In terms of the domestic market, the accessibility of patients has been greatly improved after the original research drug was included in the medical insurance in 2018. As of 2023, generic drugs from 4 local enterprises have been approved for marketing. After the implementation of centralized procurement, the price has dropped by more than 90%, and the market demand for APIs and related impurity reference substances has also grown rapidly simultaneously.

CATO can provide a full set of impurity standard substances for ixazomib API. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, with sufficient spot inventory, and can quickly respond to the full-process supply needs of pharmaceutical enterprises in drug research and development, quality research and consistency evaluation.