Brigatinib

Addressing clinical pain points such as brain metastasis and reduced efficacy in patients with ALK-positive non-small cell lung cancer (NSCLC) after developing resistance to first-generation targeted drugs, brigatinib, as a new generation of ALK tyrosine kinase inhibitor, binds to ALK fusion proteins with high selectivity, effectively inhibits multiple drug-resistant mutations including C1156Y and G1202R, and has excellent blood-brain barrier penetration ability. In clinical practice, this drug is mainly used for the first-line treatment of ALK-positive locally advanced or metastatic NSCLC and the second-line treatment of patients who have progressed after crizotinib treatment. It can significantly prolong the progression-free survival of patients, greatly improve the intracranial response rate of patients with brain metastasis, and provide a better treatment option for NSCLC patients with ALK mutations.

The global brigatinib market size has exceeded USD 1.6 billion in 2023, with a compound annual growth rate of around 18% in the past three years. The core growth drivers come from the line advancement of targeted therapy for ALK-positive NSCLC and the increased penetration rate in emerging markets. The domestic market is currently in the stage where the original research drug dominates and generic drugs are gradually entering the market. The market size in 2023 was approximately RMB 720 million. As multiple generic drugs passed the consistency evaluation and were included in provincial centralized procurement in 2024, the price drop will further promote the improvement of clinical accessibility. It is estimated that the domestic market size is expected to exceed RMB 2 billion in 2027.

The original research enterprise of brigatinib is Takeda Pharmaceutical of Japan, and the original brand name is Alunbrig. The expiration time of its core compound patent in the United States is 2026, and the expiration time of the compound patent in China is 2025. The main dosage form approved for the original research drug is tablet, with specifications including 30mg, 90mg and 180mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. In China, more than 10 enterprises have completed the A-state registration of brigatinib API through the CDE, and the original research preparation and multiple domestic preparations have been approved for marketing in China. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for brigatinib API. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most impurities are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day, which can fully meet the various needs of pharmaceutical enterprises in the stages of API R&D, quality research and registration declaration.