Trametinib

As one of the core drugs for targeted therapy of malignant melanoma, trametinib is a highly selective MEK1/2 kinase inhibitor, which can inhibit the proliferation and invasion of tumor cells by blocking the abnormal activation of the MAPK signaling pathway. In clinical practice, it is mainly used in combination with dabrafenib for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also applicable to the postoperative adjuvant therapy of patients with BRAF V600 mutation-positive stage III melanoma, as well as some patients with BRAF mutation-positive non-small cell lung cancer and anaplastic thyroid cancer, bringing long-term survival benefits to patients with rare mutation tumors who lacked effective treatment options in the past.

The global market size of trametinib has maintained steady growth in recent years, and the overall market size was close to 1.8 billion US dollars in 2023. Among them, the growth rate of the Chinese market is significantly higher than the global average, with a compound annual growth rate of 23%. The current market is still dominated by original research products. With the expiration of core patents one after another, a number of domestic pharmaceutical companies have started the R&D and declaration of generic drugs. Since 2023, 3 companies have submitted marketing applications for generic trametinib. After the generic drugs enter the market in the future, the accessibility of the drug will be further improved, driving the expansion of the overall market.

The original research enterprise of trametinib is Novartis, and the original research trade name is Mekinist. Its core compound patent will expire in China in 2026, and the core patent in the United States will expire in 2027. The dosage form approved for the original research product is tablet, with specifications of 0.5mg and 2mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, at present, 5 enterprises have obtained CDE registration numbers for trametinib APIs, among which 3 registration statuses are A, which can be used for associated preparation declaration; the original research product and 2 domestic generic trametinib tablets have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for trametinib API, which can fully meet the needs of impurity qualitative and quantitative research and quality control in the R&D process. Most of the products are in stock, and in-stock products ordered 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, helping pharmaceutical companies efficiently promote the R&D of generic drugs and consistency evaluation work.