Dabrafenib

For the treatment of malignant tumors with BRAF V600 mutation, the emergence of targeted drugs has dramatically rewritten the survival prognosis of patients, and dabrafenib is a highly representative selective BRAF kinase inhibitor among them. It specifically blocks the excessive activation of the MAPK signaling pathway mediated by BRAF V600 mutation, thereby inhibiting the proliferation and survival of tumor cells. In clinical practice, it is mainly used in combination with trametinib for indications including BRAF V600 mutation-positive unresectable or metastatic melanoma, non-small cell lung cancer, anaplastic thyroid cancer, and postoperative adjuvant therapy for melanoma, covering adult patients and some eligible pediatric patients. It is one of the core foundational medications for the treatment of this mutation target.

The global market size of dabrafenib has maintained steady growth in recent years, with sales exceeding 1.8 billion US dollars in 2023. Among them, the growth rate of the Chinese market is higher than the global average, with a compound annual growth rate of 19%. In terms of the competitive landscape, the original research product still occupies a dominant position, and the layout of domestic generic drugs is in the early stage. At present, 3 enterprises have submitted marketing applications for generic dabrafenib preparations, and the demand for API supply continues to rise along with the advancement of generic drug research and development. If centralized procurement is implemented subsequently, the cost advantage of domestic APIs will become a core element for enterprises in market competition.

The original research enterprise of dabrafenib is Novartis Pharma, and the original trade name is Tafinlar®. The expiration time of its core compound patent in China is 2028. The main dosage form approved for the original product is capsules, with specifications of 50mg and 75mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA, and is also a reference preparation recognized by the FDA. In terms of domestic API registration, there are currently nearly 10 registration numbers for dabrafenib APIs, some of which have obtained A status through the joint evaluation and approval with preparations. Both original and generic preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for dabrafenib API, covering all known and unknown impurity structures in the synthesis route and degradation process. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day, which can fully support the full-process R&D needs of pharmaceutical enterprises including API quality research, stability investigation and generic drug consistency evaluation.