Fedratinib

For non-small cell lung cancer subtypes with EGFR exon 20 insertion mutations, for which the response rate of traditional EGFR inhibitors is less than 10%, the advent of furmonertinib has filled the gap in clinical treatment. As a novel irreversible and selective epidermal growth factor receptor tyrosine kinase inhibitor, it can precisely bind to the ATP-binding pocket of EGFR exon 20 insertion mutations, and also has definite inhibitory activity against HER2 and HER4 mutations. It not only avoids severe adverse reactions such as rash and diarrhea caused by excessive inhibition of wild-type EGFR, but also significantly prolongs the progression-free survival of such patients with refractory NSCLC. At present, its clinical development also covers solid tumor indications with EGFR/HER2 mutations such as cholangiocarcinoma and glioblastoma, providing new treatment options for patients with rare mutations who have no available drugs.

Currently, there are approximately 100,000 new annual cases of NSCLC with EGFR exon 20 insertion mutations globally, and about 35,000 new annual cases in China. The market size of drugs for this niche indication had exceeded RMB 3.2 billion by 2024, with a compound annual growth rate of 41.7%. So far, only 3 drugs targeting this target have been approved for marketing worldwide. As the first domestically developed drug targeting this target that has entered Phase III clinical trials, furmonertinib has an approximately 15 percentage point higher response rate in patients with brain metastases compared with the marketed products, with a potential market space of over RMB 1.5 billion. If successfully approved, it will become the core alternative variety in this therapeutic field in China. At present, 5 domestic pharmaceutical companies have laid out their generic drug pipelines for it.

The original developer of furmonertinib is Dizal Pharmaceutical (Jiangsu), with the brand name Suwozhe®. Its Chinese compound patent will expire in 2040, and its core US patent will expire in 2041. The main dosage form currently approved for marketing is tablets, with two specifications of 50mg and 150mg, which has been included in the *Catalogue of Chemical Reference Preparations (74th Batch)* of the National Medical Products Administration. On the API level, as of now, there is no registration information of furmonertinib on the CDE API Registration Platform. Only the tablets of the original research enterprise were approved for marketing in March 2024 in China, and no generic preparations from other manufacturers have been approved. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of furmonertinib impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide full-chain impurity reference standard support for the API R&D, quality research and generic drug declaration of this variety.