Mefatinib

For the clinical treatment of non-small cell lung cancer with EGFR rare mutations and drug-resistant mutations, there have long been pain points of low response rate and limited optional drugs. The launch of mevalotinib has filled the gap in this细分 field. As a second-generation, irreversible, pan-EGFR family tyrosine kinase inhibitor independently developed in China, it can highly selectively bind to the kinase domains of EGFR, HER2 and HER4, and irreversibly block the transmission of downstream signaling pathways. It not only has significant inhibitory activity against rare mutations such as EGFR exon 18 G719X and exon 21 L861Q, but also shows definite efficacy against T790M mutation after resistance to first-generation EGFR-TKIs. Clinically, it is mainly used for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations, and has also shown considerable survival benefit in the later-line treatment of patients with rare mutations.

Patients with EGFR rare mutations in non-small cell lung cancer in China account for 10% to 15% of the total population with EGFR mutations, corresponding to approximately 80,000 new patients annually. Currently, there are fewer than 3 targeted drugs available in this field. With a higher objective response rate for rare mutations (an increase of more than 40% compared with first-generation drugs) and lower incidence rates of adverse reactions such as rash and diarrhea, mevalotinib quickly became the preferred regimen for this细分 indication after its launch. In 2023, its domestic market sales exceeded 230 million yuan, with a year-on-year growth rate of more than 320%. At present, only the original research enterprise has the production qualification of the API and preparations of this variety, and it has not yet been included in the national centralized volume-based procurement catalog, so the overall market competition landscape is favorable.

Mevalotinib is independently developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd., with the trade name Aimaida. Its core compound patent was applied for in 2013 and will expire in 2033. The domestic preparation was officially approved for marketing in March 2024, and the approved dosage form is tablet, with specifications including 40mg and 80mg. It has been included in the Catalogue of Marketing Authorized Drugs of China as the reference listed drug. In terms of API, Hengrui Pharmaceuticals has completed the API registration with the Center for Drug Evaluation (CDE), with the registration number Y20220000572 and the status of A, which can be used for associated review. At present, no other domestic enterprise has been approved for the API or preparation of this variety. (Data as of April 2025, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for mevalotinib. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use requirements in the stages of API R&D, production and quality research.