Encorafenib

For malignant tumors such as BRAF V600 mutation-positive advanced melanoma and metastatic colorectal cancer, there have long been clinical pain points of insufficient duration of targeted therapy response and high risk of drug resistance. The advent of encorafenib provides a better treatment option for this group of patients. As an oral small-molecule BRAF kinase inhibitor, it specifically blocks the abnormal activation of the MAPK signaling pathway mediated by BRAF V600 mutation to inhibit the proliferation and survival of tumor cells. It is often clinically used in combination with the MEK inhibitor binimetinib for BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, and can also be combined with cetuximab for the treatment of adult patients with BRAF V600E mutation-positive metastatic colorectal cancer, significantly prolonging the median progression-free survival and overall survival of patients.

The global market size related to encorafenib has exceeded USD 1.8 billion in 2023, with a compound annual growth rate of more than 21% in the past three years. The growth momentum mainly comes from the continuous expansion of approved indications and the improvement of clinical penetration rate of combination therapy regimens. At present, the original research product still occupies the major share of the global market, and the Chinese market is still in the stage where the imported original research product and generic drug applications coexist. More than ten domestic pharmaceutical companies have submitted marketing applications for encorafenib API and preparations. With the subsequent expiration of patents and the successive approval of generic drugs, the accessibility of related drugs will be significantly improved.

The original research enterprise of encorafenib is Pierre Fabre Pharmaceuticals, and the original research trade name is Braftovi. Its core compound patent in the United States will expire in 2028, and the core compound patent in China will expire in 2030. At present, the main dosage form approved for the original research product is oral hard capsule, with two specifications of 50 mg and 75 mg, which has been included in the FDA Reference Listed Drug Catalog. The original research preparation has been approved for marketing in China in 2024. At present, 3 domestic enterprises have completed the registration of encorafenib API at CDE, with the status of A (approved for use in marketed preparations). (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of encorafenib impurity reference standards, covering all research scenarios such as synthesis process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the full-process quality research needs of enterprises from API R&D to marketing application.