Bortezomib

Multiple myeloma is the second most common hematological malignancy. The response rate of traditional chemotherapy regimens is less than 40%, and the advent of bortezomib has completely reshaped this treatment landscape. As the world's first marketed proteasome inhibitor anti-tumor drug, it reversibly inhibits the chymotrypsin-like activity of the 26S proteasome, blocks the degradation pathway of key regulatory proteins in cells, induces tumor cell apoptosis, and reduces the supportive effect of the bone marrow microenvironment on tumor cells. Currently, this drug is the core medication for the first-line treatment of multiple myeloma, and can also be used for the treatment of relapsed/refractory mantle cell lymphoma, covering treatment-naive, relapsed and refractory patients throughout the disease course, and has greatly improved the 5-year survival rate of patients.

The peak size of the global bortezomib market exceeds 3 billion US dollars. After the expiration of its core patent in 2015, generic drugs quickly entered the market, and the overall market size has gradually declined to approximately 1.2 billion US dollars at present, but it still maintains an annual growth rate of around 8% in developing country markets. In terms of the Chinese market, the terminal sales of bortezomib in public medical institutions exceeded 2.2 billion yuan in 2023. With the逐年 increase in the prevalence of multiple myeloma and the expansion of medical insurance coverage, it is expected to maintain a steady growth rate of 6% in the next three years. At present, the domestic preparation market is jointly supplied by the originator drug and 3 local generic drug enterprises. The average price reduction of bortezomib preparations in the first three batches of national centralized drug procurement exceeded 80%, which has forced the continuous increase in demand for cost control of upstream active pharmaceutical ingredients.

Bortezomib was jointly developed by Johnson & Johnson and Millennium Pharmaceuticals as the originator, and the original brand name is Velcade®. Its core compound patent in the United States expired in 2017, and its compound patent in China also expired in 2017. The approved dosage form of the originator drug is powder for injection, with specifications of 1mg and 3.5mg. It has been included in the Reference Preparations of the China Listed Drug Catalogue, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are 23 bortezomib API registration entries on the API Registration Platform of China's Center for Drug Evaluation (CDE), of which 16 are in status A (already used in marketed preparations). Multiple domestic local enterprises have obtained marketing approval for generic bortezomib for injection. (Data as of December 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for bortezomib API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable material basis support for API and preparation enterprises in quality research, consistency evaluation, and registration and declaration work.