Vemurafenib

Malignant melanoma is a type of malignant tumor with extremely strong invasiveness and poor prognosis, among which about half of the patients carry the BRAF V600 gene mutation. The effective rate of traditional chemotherapy for patients with this subtype is less than 10%. Vemurafenib is a highly selective BRAF kinase inhibitor, which can specifically block the abnormal activation of the MAPK signaling pathway mediated by the BRAF V600 mutation, and inhibit the proliferation and survival of tumor cells. It is clinically mainly used to treat BRAF V600 mutation-positive unresectable or metastatic melanoma, and can also be used for some patients with Langerhans cell histiocytosis and Erdheim-Chester disease who carry this mutation, bringing long-term survival benefits to the mutant population who lacked effective treatment options in the past.

The global market size of vemurafenib was close to RMB 3 billion at its peak in 2021. In recent years, affected by the iteration of similar targeted drugs and patent expiration, the market size has declined to some extent. However, supported by the expansion of rare disease indications with BRAF mutations, the market size remained at around RMB 1.7 billion in 2023, with the compound annual decline rate narrowing to less than 5%. At present, the original research product still accounts for the dominant share in the global market. There is no generic drug launched in China yet, the supply of preparations is completely dependent on imports, and large-scale competition has not yet been formed in the commercial production of active pharmaceutical ingredients. Subsequently, with the launch of generic drug applications after patent expiration, the demand for upstream API will see a phased growth.

The original research enterprise of vemurafenib is Roche, and the original research brand name is "Zelboraf". The expiration date of its core compound patent in China is March 2028. The main dosage form approved for the original research product is film-coated tablet, with a specification of 240 mg. The original research preparation has been included in the China Listed Drug Catalogue, and is the officially recognized reference preparation. As of now, there is no generic vemurafenib preparation approved for marketing in China, and no enterprise has submitted an A-status registration number for vemurafenib on the CDE API registration platform, with only a small number of enterprises submitting registrations in the clinical trial application stage. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for vemurafenib, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the stages of API R&D, quality research and generic drug application.