Mitomycin

As a classic antineoplastic antibiotic drug, mitomycin cross-links with DNA double strands to inhibit the DNA replication of tumor cells, and can also induce free radicals to damage lipid membranes, possessing both broad-spectrum anti-tumor activity and immunomodulatory effects. It is mostly used clinically for systemic chemotherapy and intracavitary perfusion therapy of solid tumors such as gastric cancer, lung cancer, breast cancer and bladder cancer, among which bladder perfusion administration is one of the current standard regimens for preventing recurrence after non-muscle invasive bladder cancer surgery, and the applicable population covers patients with solid tumors at all stages who require chemotherapy and postoperative adjuvant therapy.

The current global market size of mitomycin is approximately USD 320 million, with the annual compound growth rate maintained at 4.1%. The steady growth rate is mainly attributable to the rigid clinical demand for indications such as bladder cancer and the steady expansion of generic drug supply. In terms of the domestic market, after the volume-based procurement drove down the terminal price, the clinical accessibility has been significantly improved. In 2023, the sales volume in domestic sample hospitals exceeded RMB 180 million, of which domestic generic drugs accounted for more than 70% of the market. The main suppliers of active pharmaceutical ingredients (APIs) are enterprises from China and India, with a relatively high industry concentration.

The original developer of mitomycin is Kyowa Kirin Co., Ltd. of Japan, with the original brand name "Mutamycin", and its core compound patent expired globally in 1988. The currently approved main dosage form is powder for injection, with specifications covering 2mg, 10mg and 20mg. The original preparation has been included in the FDA Reference Listed Drug (RLD) Catalog, and is also included in the *Catalog of Reference Preparations of Chemical Drugs* of China. As of now, 6 domestic enterprises have obtained CDE registration numbers for mitomycin APIs, all with the status of "A" (approved for use in marketed preparations), and 8 domestic enterprises have obtained marketing approval for mitomycin for injection. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of mitomycin impurity reference standards, covering the full-chain reference material demands including synthetic starting materials, intermediates and degradation impurities. Most 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 effectively support the full-cycle work including API R&D, quality research and post-marketing stability study.