Selumetinib

Neurofibromatosis is a type of rare genetic disease that severely affects the quality of life of patients. Among them, neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas have long lacked effective systemic treatment options due to the lesions involving multiple tissues and the high difficulty of surgical resection. Selumetinib is a selective inhibitor of mitogen-activated protein kinase kinase (MEK1/2). By targeted blocking the excessive activation of the RAS/MAPK signaling pathway, it inhibits the proliferation of tumor cells. It is the world's first targeted drug approved for pediatric patients with NF1-associated plexiform neurofibromas. Currently, it is also being expanded into clinical research for solid tumors such as thyroid cancer and non-small cell lung cancer, providing the possibility of long-term disease control for patients with inoperable lesions.

At present, the global market size of selumetinib has exceeded 1.2 billion US dollars, and the compound annual growth rate in the past three years has maintained at around 37%. The growth in demand is mainly driven by the improvement of the rare disease medication security system and the clinical expansion of solid tumor indications. The domestic market is still in its infancy. The original research product was officially approved for entry into China in 2023, and there are no generic drugs on the market at present, so the market competition pattern is highly concentrated. With the expansion of medical insurance coverage for rare disease medications, it is expected that the domestic market compound annual growth rate will exceed 45% in the next five years.

The original research enterprise of selumetinib is AstraZeneca, and the original brand name is "Koselugo". Its core compound patent in the United States will expire in 2028, and the expiration date of its compound patent in China is 2030. The dosage form approved by the original research is capsules, with specifications including 10mg and 25mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *List of Chemical Drugs* of China. In terms of domestic API registration, no enterprise has obtained the A-status API registration number for selumetinib at present. Only the original research preparation has been approved for marketing, and no domestic generic preparation has been declared. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for selumetinib API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.