艾姆地芬

The treatment of advanced solid tumors has long faced clinical dilemmas of single target and prominent drug resistance. As a novel oral small-molecule PD-L1 inhibitor independently developed in China, Imedifan provides a differentiated treatment option for this field. Its mechanism of action breaks through the administration limitations of macromolecular antibodies. By blocking the PD-1/PD-L1 immune checkpoint pathway, it relieves the immunosuppression of T cells by tumor cells and reactivates the body's anti-tumor immune response. Currently, this drug is in the clinical trial stage, and its intended development indications cover a variety of high-incidence advanced solid tumors such as non-small cell lung cancer, liver cancer, and gastric cancer. It is expected to bring a new treatment path for patients who cannot tolerate macromolecular monoclonal antibodies and require home-based oral treatment.

The current global market size of PD-(L)1 inhibitors has exceeded 35 billion US dollars. As a segmented innovative track, small-molecule PD-L1 inhibitors have achieved a compound annual growth rate of more than 40% in the past 3 years, which is much higher than the overall growth rate of macromolecular monoclonal antibodies. The number of domestic innovative pharmaceutical companies布局 in this field ranks first in the world. As one of the domestic small-molecule PD-L1 inhibitors with the fastest development progress, Imedifan has received increasing market attention. At present, there is no domestically produced small-molecule PD-L1 inhibitor approved for marketing in the relevant field. If it is successfully approved in the subsequent stage, it is expected to fill the gap in the segmented market by virtue of its oral administration convenience and cost advantages.

The original research enterprise of Imedifan is Guangzhou Beigene Pharmaceutical Co., Ltd. No commercial product name has been announced yet. Its core compound patent was applied for in 2019, and the patent term expires in 2039. The currently developed dosage form is oral tablet, with specifications including 60mg, 120mg, etc. It is in the Phase III clinical trial stage and has not been included in the domestic and foreign reference preparation catalogs. Up to now, no API registration information of Imedifan has been found on the CDE API registration platform, and no relevant preparation has been approved for marketing in China. (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 Imedifan, which meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are available from stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet the needs of various scenarios such as impurity research and quality control in the drug development stage.