Lifitegrast

Dry eye disease, as a chronic ocular surface disease with high global incidence, has long been dominated by artificial tears to relieve symptoms, and lacks fundamental treatment regimens targeting the inflammatory mechanism. Lifitegrast is an innovative drug belonging to the lymphocyte function-associated antigen-1 (LFA-1) antagonist class. By blocking the binding of LFA-1 to intercellular cell adhesion molecule-1 (ICAM-1), it inhibits T cell activation and the release of related inflammatory factors, intervening in the progression of dry eye disease from the level of pathogenesis. It is indicated for the treatment of signs and symptoms of dry eye disease in adult patients, and is the world's first targeted small molecule drug targeting ocular surface inflammation.

The current global prevalence of dry eye disease is approximately 5% to 35%, and the prevalence among the adult population in China exceeds 21%, with the patient base having surpassed 200 million. In 2023, the global market size related to lifitegrast was approximately USD 870 million, with a compound annual growth rate of more than 12% in the past three years. In recent years, the growth rate of the dry eye disease medication market in public medical institutions in China has remained stable at around 18%. At present, lifitegrast is still in the stage of original research exclusivity in China, and no generic drug has been approved for marketing. With the increase in patients' awareness of targeted therapy, the future market substitution space is considerable.

The original research enterprise of lifitegrast is Shire (USA), which now belongs to Takeda Pharmaceutical, and the original research trade name is Xiidra. The expiration date of its core compound patent in the United States is 2029, and the expiration date of its compound patent in China is 2030. The dosage form approved for the original research product is eye drop, with the specification of 5% (0.2ml per vial, 0.4ml per vial). It has been included in the FDA Reference Listed Drug Catalog, and has not yet been included in the *Catalog of Reference Listed Drugs of Chemical Drugs* of China. There are no registered varieties of marketed lifitegrast API in China. The original research imported preparation was approved for marketing by the National Medical Products Administration in 2023, and at present, multiple domestic enterprises have submitted clinical trial applications for generic drugs. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for lifitegrast API. Most products are in regular stock, and orders placed before 16:00 can 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 various needs in the stages of drug research and development, quality research and registration application.