Ixazomib

Multiple myeloma is an incurable hematological malignancy, and its clinical treatment has long relied on proteasome inhibitors as core therapeutic agents. Ixazomib is the world's first oral proteasome inhibitor, which reversibly inhibits the chymotrypsin-like activity of the 20S proteasome, blocks the degradation pathway of proteins related to tumor cell proliferation, and ultimately induces tumor cell apoptosis. As the world's first oral proteasome inhibitor, ixazomib is used in combination with lenalidomide and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least one prior first-line therapy. The characteristic of oral administration greatly reduces the frequency of patients' trips to medical institutions, and is especially suitable for elderly patients and patients with mobility difficulties who require long-term maintenance treatment.

In 2023, the global market size of ixazomib was approximately USD 1.38 billion, with a compound annual growth rate of 4.2% in the past three years. The growth momentum mainly comes from the increasing penetration rate of oral anti-myeloma drugs in emerging markets. In terms of the Chinese market, since ixazomib was included in the National Medical Insurance Catalog in 2018, its clinical utilization rate has risen rapidly. In 2023, the sales volume in domestic sample hospitals exceeded RMB 860 million, with an annual growth rate of 27.3%. At present, the original research product still accounts for nearly 65% of the domestic market share, and 3 local enterprises have obtained marketing approval for their generic preparations. The demand for API is continuously releasing under the pressure of centralized procurement.

The original research enterprise of ixazomib is Takeda Pharmaceutical of Japan, and the original trade name is "Ninlaro®". Its core compound patent in China expired in 2023. The dosage form approved by the original research is oral hard capsule, with three specifications of 2.3mg, 3mg and 4mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs (29th Batch)* of China, and is also listed in the FDA Reference Preparation Catalogue. In terms of domestic API registration, 6 enterprises have completed the registration of ixazomib API with the CDE (status as A) as of now, and another 11 enterprises have their generic preparations in the stage of marketing application or clinical trial. (Data as of November 2024, please refer to the official website of CDE for the latest information.)

CATO provides a full set of impurity reference standards for ixazomib API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, the products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process demands of API and preparation enterprises in R&D, registration and quality control.