Everest Medicines (1952) has obtained approval from China’s National Medical Products Administration for the New Drug Application of VELSIPITY® (etrasimod arginine tablets). The therapy is indicated for adult patients with moderately to severely active ulcerative colitis who have shown insufficient response, lost response, or intolerance to conventional or biologic treatments. VELSIPITY®, a next-generation selective sphingosine 1-phosphate receptor modulator, is administered orally once daily and aims to achieve rapid onset of action alongside sustained clinical remission.

The approval was supported by the Asia-based Phase 3 ENLIGHT UC study (ES101002) and the global ELEVATE UC Phase 3 program (ELEVATE UC 52 and ELEVATE UC 12). ENLIGHT UC is noted as the largest Phase 3 trial of moderately to severely active ulcerative colitis in Asia to date, enrolling 340 participants. The studies demonstrated statistically significant efficacy across both induction and maintenance phases, with no new safety concerns.

According to the announcement, this regulatory milestone aligns with Everest Medicines’ 2030 strategy focused on driving near-term growth through commercialization, partnerships, and research and development, while also fostering long-term expansion on a global scale. The company targets multiple therapeutic areas including renal, autoimmune, critical care, cardiovascular, and ophthalmic diseases, aiming for annual revenue exceeding RMB10 billion by 2028 and RMB15 billion by 2030. Projections also highlight more than 20 commercial products by 2030, encompassing NEFECON®, VELSIPITY®, XERAVA®, Lerodalcibep, and MT1013.

In addition, the company intends to accelerate international growth through overseas out-licensing and direct commercialization. This approach includes bringing in three-to-five late-stage, high-value assets annually and emphasizing advancements in key therapeutic fields. By leveraging strategic partnerships and in-house R&D, Everest Medicines aims to establish a globally competitive biopharmaceutical portfolio capable of delivering sustained growth.

Ulcerative colitis remains a chronic inflammatory bowel disease with an increasing patient population in China, projected to rise from approximately 0.98 million in 2025 to 1.50 million by 2031. Symptoms such as bloody stools, abdominal pain, and diarrhea substantially affect long-term quality of life. The newly approved oral treatment VELSIPITY® is also approved in other regions, including the United States, European Union, Japan, Australia, and several others, further supporting its potential to address critical medical needs in the field of ulcerative colitis.