What is the situation with Genting Xinyao’s Etrasimod-Velsipity?

Etrasimod (Etrasimod) is a new oral small molecule drug developed by Pfizer. It is mainly used to treat moderately to severe active ulcerative colitis (UC). As a first-line advanced therapy, its emergence has brought new treatment ideas to the field of inflammatory bowel disease. The mechanism of Itramod is to selectively regulate the S1P receptor (Sphingosine-1-phosphate receptor). By regulating the migration and distribution of lymphocytes in the intestine, it reduces intestinal inflammatory response, thereby improving the patient's symptoms and intestinal mucosal inflammation. This mechanism of action is different from traditional immunosuppressants and biological agents, and reflects the characteristics of precise targeted therapy.

On December 17, 2024, Genting Xinyao announced that the China National Medical Products Administration has officially accepted the new drug marketing authorization application (NDA) for itrimod tablets for the treatment of moderately to severely active ulcerative colitis. This news indicates that itridimod is expected to become the first oral S1P receptor modulator in China, filling the gaps in existing treatment options in terms of safety, convenience and sustained efficacy. This drug is taken orally once a day, and the patient's medication burden is relatively light. It is especially suitable for patients with moderate to severe UC who require long-term maintenance treatment. In addition, clinical data show that while improving symptoms, itridimod has a patient-friendly safety profile, with relatively mild common adverse reactions and good tolerability.

At present, itrimod is not yet on the market in China, so domestic patients do not yet have direct access to drug treatment. Despite this, the drug has been approved in some overseas countries, such as the United States and Europe, and is used clinically for the management of patients with ulcerative colitis. The marketing experience of foreign original drugs provides reference for future clinical applications in China, and also provides reference data for patients and doctors, such as information on maintenance of efficacy, improvement of quality of life, and long-term safety observation.

Reference materials:https://www.drugs.com/mtm/etrasimod.html