The Department of Health of the Hong Kong Special Administrative Region has approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), Everest Medicines announced today.
This approval makes Hong Kong the third region within Everest Medicines' licensed territory to approve VELSIPITY®, following previous approvals in Macau and Singapore. Additionally, China's National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY® in December 2024.
VELSIPITY® is a once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. The drug has already received regulatory approvals in multiple markets including the U.S., EU, Canada, Australia, and the UK through Everest's licensing partner, Pfizer.
Strong Clinical Evidence Supports Approval
The Hong Kong approval was based on results from the ELEVATE UC Phase 3 registrational program, which included two studies: ELEVATE UC 52 and ELEVATE UC 12. Both studies achieved all primary and key secondary efficacy endpoints, demonstrating a favorable safety profile consistent with previous etrasimod studies.
Notably, etrasimod has been included in the American Gastroenterological Association (AGA) Living Clinical Practice Guideline on the pharmacological management of moderate-to-severe UC as one of the higher-efficacy medications suggested for first-line use in advanced therapy-naïve patients.
"The approval of VELSIPITY® in Hong Kong marks an important milestone in bringing this innovative therapy to UC patients," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "In 2022, there were approximately 600,000 patients with UC in China, and the number is estimated to reach 1 million by 2030, reflecting the significant unmet need for advanced treatment options."
Expert Perspective on Clinical Impact
Professor Wu Kaichun at the First Affiliated Hospital of AFMU, who served as the principal investigator for etrasimod's Asia clinical trial, highlighted the drug's clinical significance: "As a next-generation selective S1P receptor modulator, once-daily oral etrasimod demonstrates robust efficacy across multiple endpoints, including mucosal healing, endoscopic normalization and histological remission."
He further emphasized the progressive nature of UC, noting that "as the disease progresses, the risk of disability and colorectal cancer incidence continues to rise. We look forward to its approval in more regions to benefit more patients."
Expanding Access in Greater China
VELSIPITY® has already been introduced to hospitals in the Greater Bay Area through the 'Hong Kong and Macau Medicine and Equipment Connect' policy. The drug has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC and is now available at designated medical institutions under the Connect Policy in the Greater Bay Area.
To support future demand, Everest has launched a construction project at its Jiashan factory to support local production of VELSIPITY®. As Everest's third commercialized product, VELSIPITY® represents an important addition to the company's growing portfolio of innovative therapeutics.
About Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing, non-specific inflammatory disease that affects the colon and rectum. The condition can significantly impact quality of life and, if left untreated, increases the risk of disability and colorectal cancer. The rising prevalence of UC in China—from approximately 600,000 patients in 2022 to an estimated 1 million by 2030—underscores the growing need for effective treatment options.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing, and commercializing transformative pharmaceutical products and vaccines for patients in Asian markets. The company has built a portfolio of potentially global first-in-class or best-in-class molecules in core therapeutic areas including renal diseases, infectious diseases, and autoimmune disorders.
With VELSIPITY® now approved in Hong Kong, Macau, and Singapore, and under regulatory review in mainland China, Everest Medicines continues to expand access to innovative therapies across its licensed territories.
