On December 17, according to the official website of CDE, Genting New Energy's application for marketing approval of the Class 5.1 imported chemical drug "Itramod Tablets" was accepted for the treatment of moderate to severe active ulcerative colitis.
According to public information, Itramod tablets were originally developed by Arena. Pfizer acquired the company in 2022 and included the drug in its pipeline.

Billion-dollar sales prospects
target the "million-patient market"

Inflammatory bowel disease (IBD) is a type of disease that causes inflammation of the digestive system, and the number of patients worldwide is on the rise. IBD mainly includes ulcerative colitis and Crohn's disease, of which ulcerative colitis is common in patients aged 20 to 30 years old, and clinical manifestations include persistent or recurrent diarrhea, mucus, pus and blood in the stool with abdominal pain, and even skin lesions and mucosal lesions. At present, the cause of the disease has not been fully clarified.
According to statistics, the global prevalence of ulcerative colitis in 2023 is about 5 million cases, and the incidence rate continues to show an upward trend; in China, there will be about 600,000 patients with ulcerative colitis in 2022, and it is expected that the number will exceed 1 million in 2030, almost doubling that in 2019. The

huge market demand has made ulcerative colitis a "must-fight place" for various pharmaceutical companies, but because the cause of the disease has not yet been clarified, it is difficult to avoid "loss of secondary response" and other similar "drug resistance" in patients, so more new drugs are still needed clinically to meet treatment needs.

Itramod is a new generation of highly selective sphingosine-1-phosphate (S1P) receptor modulator developed by Arena (acquired by Pfizer in 2022). Everest Medicines obtained its exclusive rights in Greater China and South Korea in 2017. Itramod uses an optimized pharmacological design and binds to S1P receptors 1, 4 and 5. Studies have shown that it has good efficacy and safety in the treatment of moderate to severe active ulcerative colitis.

In October 2023, Itramod was approved by the U.S. FDA for marketing for moderate to severe active ulcerative colitis; in February 2024, the drug was approved for marketing by the European Union as a new drug, becoming its first and only new generation oral drug for the treatment of ulcerative colitis approved for patients aged 16 and above. Itramod was then launched in Macau, Singapore and other regions in China, and was launched in the Guangdong-Hong Kong-Macao Greater Bay Area through the "Hong Kong and Macao Drug and Medical Device Access" policy. According to statistics, among the approximately 600,000 patients with ulcerative colitis in my country in 2022, the number of patients in Guangdong Province was about 60,000, accounting for as high as 10%. Itramod provides a new treatment option for patients in the region.

At the same time, Pfizer is also studying the therapeutic potential of Itramod for Crohn's disease, atopic dermatitis and other diseases. According to Evaluate Pharma's forecast, Itramod's sales are expected to reach US$909 million (about RMB 6.5 billion) in 2026. The drug's application for listing in China is expected to further expand its market prospects and bring new options to related patients.

Although there are many treatment options for inflammatory bowel diseases such as ulcerative colitis, there is still a great demand for more effective and safe treatments due to drug resistance and other issues. In the future, in addition to developing new drugs based on existing targets, continued exploration of new targets may also become one of the key research directions for related drug development.

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