Binimetinib

As a targeted therapeutic drug targeting the MAPK signaling pathway, binimetinib is a reversible inhibitor of mitogen-activated extracellular signal-regulated kinase 1/2 (MEK1/2). By blocking the phosphorylation process of MEK kinase, it inhibits the abnormal activation of the downstream ERK signaling pathway, thereby controlling the proliferation and survival of tumor cells. Clinically, this drug is mainly used in combination with BRAF inhibitors for the treatment of patients with unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations. It has also demonstrated application potential in clinical trials for solid tumors such as glioma and colorectal cancer, providing longer progression-free survival benefits for patients with advanced tumors of specific mutation subtypes.

The global MEK inhibitor market has maintained a steady growth trend in recent years, with the overall market size exceeding US$2.8 billion in 2023. Among them, binimetinib, relying on its combination regimen with encorafenib, accounts for approximately 17% of the market share in the first-line treatment field of BRAF-mutant melanoma. At present, only the original research manufacturer has achieved large-scale production of this API on a global scale, and no generic drug has been launched in China. With the逐年 increase in the penetration rate of targeted therapy for melanoma, the clinical demand for this product in the domestic market is expected to maintain a compound annual growth rate of more than 12%.

The original research manufacturer of binimetinib is Array BioPharma, and the original brand name is Mektovi. Its core compound patent will expire in 2031 in major markets such as the United States and the European Union, and the compound patent in China will also expire in 2031. The main dosage form approved by the original research is oral tablets with a specification of 15 mg. The original product has been included in the FDA Reference Listed Drug Catalog, and has not yet been included in the Chinese Catalog of Chemical Drugs. As of now, there is no registered DMF filing information for binimetinib API in China, and no formulation of this product has been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for binimetinib API, and most products are available from stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of drug development, quality research and production.