Foritinib

Addressing the clinical pain points of insufficient control of brain metastases and frequent drug resistance in the treatment of ALK-positive non-small cell lung cancer (NSCLC) patients, the second-generation ALK inhibitor furmonertinib demonstrates significant clinical advantages. As a highly selective anaplastic lymphoma kinase (ALK) inhibitor, it potently inhibits the autophosphorylation of ALK kinase and the transduction of downstream signaling pathways, thereby blocking the proliferation and survival processes of tumor cells. Clinically, it is mainly used for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer, and also has favorable intracranial anti-tumor activity in patients with baseline brain metastases, effectively filling the clinical gap in brain lesion control of similar drugs.

Currently, the annual number of newly diagnosed ALK-positive NSCLC patients in China is approximately 35,000, the overall market size of ALK inhibitors has exceeded 9 billion yuan, with an annual compound growth rate of around 23%. As a domestically developed innovative second-generation ALK inhibitor, furmonertinib, with its superior intracranial response rate and lower incidence of adverse reactions, quickly broke the market monopoly of imported products after its launch. In the current domestic second-generation ALK inhibitor market, the market share of domestic products has risen to 42%. With the expansion of medical insurance coverage, the market penetration space of furmonertinib will be further enhanced.

The original research enterprise of furmonertinib is Chongqing Fochon Pharmaceutical Research Co., Ltd., with the brand name Samina®. The core compound patent of furmonertinib will expire in June 2038. At present, the main dosage form approved in China is oral tablet, with specifications of 100mg and 50mg, which has been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration has not publicly announced the marketing registration information of the active pharmaceutical ingredient (API) of this product, and the only preparation approved in China is furmonertinib fumarate tablets produced by the original research enterprise. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for furmonertinib API, covering the whole chain of impurity types including those from the synthesis process and degradation products. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable reference substance support for pharmaceutical enterprises in quality research and consistency evaluation work.