Everest Medicines has announced the launch of VELSIPITY® (etrasimod) in the Guangdong-Hong Kong-Macau Greater Bay Area, offering a new treatment option for patients with moderately to severely active ulcerative colitis (UC). The approval was granted through the "Hong Kong and Macau Medicine and Equipment Connect" policy, enabling its use in designated hospitals, including Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University.
VELSIPITY® is an innovative, advanced oral therapy approved by the Pharmaceutical Administration Bureau of Macau in April 2024. It is administered once daily for patients aged 16 and above with moderately to severely active UC. Ulcerative colitis is a chronic, relapsing inflammatory disease, and its prevalence is expected to rise significantly in China. By 2030, the number of UC patients is projected to more than double compared to 2019, reaching approximately 1 million.
Expansion and Accessibility
"The launch of VELSIPITY® in the Greater Bay Area accelerates the access to this advanced therapy in mainland China, offering a new option for patients with moderately to severely active UC," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. The company plans to submit a new drug application (NDA) for VELSIPITY® in mainland China by the end of this year to further enhance its accessibility.
Development and Approvals
Originally developed by Arena Pharmaceuticals (acquired by Pfizer in 2022), Everest Medicines holds exclusive rights to develop, produce, and commercialize VELSIPITY® in Greater China and South Korea since 2017. VELSIPITY® has been approved in the United States, the European Union, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau. A new drug application has also been submitted in Hong Kong, China.
Clinical Trial Data
VELSIPITY® is the first and only advanced oral UC therapy approved for use in patients 16 years of age or older in the EU. Phase 3 clinical trials, including ELEVATE UC 52 and ELEVATE UC 12, included patients with isolated proctitis. Results from an Asian multi-center Phase 3 clinical trial demonstrated positive topline data in both induction and maintenance treatment periods, with a favorable safety profile and convenient once-daily administration.
About VELSIPITY® (etrasimod)
VELSIPITY® (etrasimod) is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5.
