Visipine®, the first and only oral S1P receptor modulator for ulcerative colitis in my country, has been approved, ushering in a new era of “deep healing”.

February 12, 2026  Source: drugdu 36

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On February 6, 2026, the National Medical Products Administration (NMPA) of China officially approved Velisipity® (arginine eltromod tablets) for marketing, for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate response, loss of response, or intolerance to conventional therapies or biologics. This drug fills a significant gap in the treatment of moderate to severe ulcerative colitis and provides a new option for innovative oral treatments targeting deep mucosal healing.

As a new generation of highly selective S1P receptor modulators, Visiprine® is taken orally once daily, enabling rapid onset of action and potent deep mucosal healing, while also possessing good safety profiles. It has the potential to be the best-in-disease and provides a new first-line treatment option for adult patients with ulcerative colitis.

The incidence of UC is rising and showing a trend towards affecting younger people.
Mucosal healing has a low clinical success rate and is difficult to achieve treatment goals.

In recent years, the incidence of ulcerative colitis (UC) in China has continued to rise and is showing a trend towards affecting younger people. The number of patients is expected to increase from approximately 980,000 in 2025 to approximately 1.5 million in 2031. As a chronic inflammatory bowel disease with an unclear etiology and a high relapse rate, UC clinically manifests as symptoms such as mucus and bloody stools, abdominal pain, diarrhea, and tenesmus, which seriously affect patients' long-term quality of life.

However, for a long time, the treatment of ulcerative colitis in my country has faced many limitations, including limited efficacy of traditional therapies, high recurrence rates, poor administration convenience, and numerous adverse reactions. Approved biological agents and small molecule therapies also suffer from issues such as "efficacy ceiling" and "loss of response."

Mucosal healing is consistently listed as a core treatment goal for UC by authoritative guidelines and consensus both domestically and internationally, but it has long been hampered by low achievement rates and weak clinical progress. The "China IBD Blue Book" shows that in clinical practice, only 24% of UC patients achieve endoscopic mucosal healing.

"China is currently experiencing a rapid increase in the incidence and prevalence of ulcerative colitis. This disease often recurs, severely impacting patients' quality of life and placing a heavy burden on individuals, families, and medical resources. Achieving mucosal healing helps to more effectively control symptoms, reduce the risk of recurrence, and improve patients' quality of life. Mucosal healing is a treatment goal for ulcerative colitis recognized by clinical guidelines both domestically and internationally. This is not only related to long-term symptom relief but also closely linked to improving patients' quality of life," explained Professor Chen Minhu, former chairman of the Chinese Society of Gastroenterology, head of the Inflammatory Bowel Disease Group, academic leader and chief expert of the Department of Gastroenterology at the First Affiliated Hospital of Sun Yat-sen University .

"Vesop®, as a new generation of highly selective S1P receptor modulator, can achieve rapid onset of action and clinical remission through a once-daily oral treatment regimen. It also shows significant efficacy in mucosal healing and histological improvement, while having a good safety profile, providing a new treatment option for adult patients with moderate to severe active ulcerative colitis," Professor Chen Minhu further stated.

Visip® achieves a mucosal healing rate of 51.9%.
It can significantly reduce the risk of recurrence and cancer.

The approval of Vivepin® is based on the results of the Asian multicenter Phase III registration clinical trial ENLIGHT UC (ES101002) and the global Phase III registration trial ELEVATE UC (including ELEVATE UC 52 and ELEVATE UC 12 studies).

According to Professor Wu Kaichun, lead investigator of the VISAP® Asia-Pacific clinical trial, Executive Committee Member and Treasurer of the World Gastroenterological Organization, Vice President of the Asia-Pacific Gastroenterological Society, Vice Chairman of the 10th and 11th Chinese Society of Gastroenterology, and Professor at Xijing Hospital of Air Force Medical University , VISAP® controls intestinal inflammation at its source and promotes mucosal healing by regulating lymphocyte migration. In multiple clinical studies, VISAP® has demonstrated significant efficacy, particularly in rapid onset of action, achieving hormone-free remission, and deep mucosal healing, showing clear clinical advantages. The Asian multicenter Phase III ENLIGHT UC study showed that after 40 weeks of maintenance therapy with VISAP®, the clinical remission rate was 48.1%, the mucosal healing rate was 51.9%, and the endoscopic normalization rate was 45.5%, with good safety and tolerability.

“As the first Phase III registration clinical trial targeting Asian patients with moderate to severe active ulcerative colitis, the data from this study validated the good efficacy and safety of VISAP® in Chinese and Asian patients. The results were published in *The Lancet Gastroenterology & Hepatology*, a sub-journal of the top international journal *The Lancet*, gaining global academic recognition,” said Professor Wu Kaichun . “This approval marks the complete validation of VISAP® from clinical research to market launch, providing patients with innovative treatment options and propelling the management of moderate to severe ulcerative colitis into a new stage.”

“The approval of Vyspept® not only reflects the clinical value of innovative therapies in the treatment of ulcerative colitis, but also demonstrates the company’s long-term strategy of adhering to international R&D standards to promote the development of innovative drugs,” said Wu Yifang, Chairman of the Board of Directors of Everest Medicines. “We look forward to enabling more patients to benefit from high-quality, breakthrough treatment options by continuously expanding our global footprint.”

Top-tier recommendations from international authoritative guides
Localized production launches to improve patient accessibility

Ulcerative colitis, a chronic nonspecific inflammatory bowel disease, is characterized by recurrent flare-ups. Patients often require long-term medication to maintain remission and reduce the risk of relapse and complications. Given these disease management needs, the long-term safety of the medications is extremely crucial.

After long-term clinical research and verification, Vysip® has demonstrated the advantages of low incidence of tumors and infections, and its good long-term treatment safety provides strong support for the long-term clinical application of this drug in patients with ulcerative colitis.

Based on its excellent clinical efficacy and good safety profile, the clinical value of Vistipr® has been fully recognized by multiple authoritative international guidelines. Currently, this drug has been included in the 2024 American Gastroenterological Association (AGA) Clinical Practice Guidelines, recommended as a first-line treatment for ulcerative colitis; and in June 2025, it was included in the "2025 ACG Clinical Guidelines: Adult Ulcerative Colitis," strongly recommended for induction and maintenance therapy of moderate to severe active ulcerative colitis, fully demonstrating the high recognition of its efficacy and safety by authoritative international academic institutions.

Vistiprine® offers a promising oral treatment option for adults with moderate to severe active ulcerative colitis, providing once-daily administration with a favorable benefit-risk profile and the potential for hormone-free remission. Everest Medicines CEO, Luo Yongqing, stated that Everest Medicines will accelerate the commercialization of Vistiprine® and actively promote its inclusion in the National Reimbursement Drug List, continuously improving the accessibility and affordability of innovative therapies in China so that more patients can benefit.

As its clinical value gains increasing recognition, the accessibility of VISAPP® continues to expand. In 2024, VISAPP® was included in the list of urgently needed imported Hong Kong and Macao drugs and medical devices in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area (named "Itramod" in the document), achieving clinical application in the Greater Bay Area for the first time. Currently, VISAPP® has obtained new drug marketing approval in the United States, the European Union, and multiple countries and regions including mainland China, Hong Kong, Macao, and Singapore. In March 2025, Everest Medicines launched the VISAPP® Jiashan factory construction project, providing strong support for localized production and long-term accessibility.

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