Tucatinib

In response to the demand for later-line treatment of HER2-positive breast cancer, tucatinib, as a highly selective HER2 tyrosine kinase inhibitor, can specifically block the phosphorylation of HER2 downstream signaling pathways, while having extremely low inhibitory activity against EGFR, greatly reducing off-target adverse reactions such as rash and diarrhea. In clinical practice, it is mainly used in combination with capecitabine for patients with locally advanced or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2 regimen. It has a significant benefit especially in the population with brain metastases, can effectively prolong intracranial progression-free survival, and fills the clinical gap in the treatment of HER2-positive breast cancer with brain metastases.

The global tucatinib market size exceeded US$850 million in 2023, with a compound annual growth rate of 42% in the past three years. The core growth drivers are the release of clinical demand for breast cancer with brain metastases and the expansion of combination therapy with other HER2 monoclonal antibodies and ADC drugs. At present, the global market is still dominated by the original research product, and the Chinese market is still in the exclusive stage of the original research product. More than 20 domestic pharmaceutical companies have laid out generic drug research and development, among which 3 have submitted bioequivalence test applications. It is expected that market competition will heat up rapidly after the patent expires.

The original research enterprise of tucatinib is Seagen, and the original trade name is Tukysa. Its core compound patent in the United States will expire in 2030, and the compound patent in China will expire in 2031. The dosage form approved for the original product is tablet, with two specifications of 50mg and 150mg, which has been included in the FDA Reference Listed Drug Catalog, and entered the Chinese market in 2022 through priority review. At present, there is no publicly available API registration number in Category A in China, and only the original imported preparation has been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for tucatinib API. Most of the 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 compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the reference standard needs of pharmaceutical enterprises in the whole process of R&D, quality research and declaration.