Erdafitinib

For patients with advanced urothelial carcinoma harboring FGFR gene abnormalities, the response rate of traditional chemotherapy and immunotherapy is less than 20%, and there are a large number of unmet clinical treatment needs. Erdafitinib, the world's first approved oral small-molecule tyrosine kinase inhibitor targeting FGFR1/2/3/4, exerts an anti-tumor proliferation effect by selectively blocking the kinase activity of FGFR and inhibiting the abnormal activation of downstream signaling pathways such as RAS/MAPK. At present, it has been approved for adult patients with locally advanced or metastatic urothelial carcinoma carrying FGFR2/3 mutations or fusions who have progressed during or after platinum-based chemotherapy. Meanwhile, it is in multiple clinical research stages for solid tumors with high incidence of FGFR abnormalities such as cholangiocarcinoma and hepatocellular carcinoma, providing a new option for precise targeted therapy.

The global market size of erdafitinib was approximately USD 420 million in 2023, with a compound annual growth rate of 38% from 2021 to 2023. The core growth drivers are the increasing penetration rate of FGFR detection for urothelial carcinoma and the clinical expansion of indications for other solid tumors. Currently, the original research drug still occupies the major market share globally, and no generic drug has been approved in China. As of 2024, more than 10 domestic pharmaceutical companies have initiated bioequivalence trials for generic erdafitinib. With the expiration of core patents, the launch of generic drugs in the future will significantly improve the accessibility of the drug.

The original developer of erdafitinib is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, with the trade name Balversa. Its core compound patent in the United States will expire in 2028, and the compound patent in China will expire in 2029. The dosage form approved for the original research drug is tablet, covering three specifications of 3mg, 4mg and 5mg. It has been included in the FDA Orange Book Reference Listed Drug Catalog, but has not yet been included in China's *Catalog of Reference Listed Drugs for Chemical Products*. There is no marketed erdafitinib API registration number in China. The original research preparation was approved for import and marketing by the National Medical Products Administration in 2023. At present, 3 domestic pharmaceutical companies have submitted API marketing registration applications, which are under the review and approval process. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for erdafitinib API, covering all categories such as process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the various needs of pharmaceutical companies in the stages of R&D, quality research and registration submission.