Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the Department of Health of the Government of the Hong Kong Special Administrative Region, China, has officially approved the New Drug Application (NDA) for VELSIPITY^® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

Following approvals in the Macau and Singapore, Hong Kong has become the third region within Everest Medicines' licensed territory to approve VELSIPITY^®. NMPA of China has also officially accepted the NDA for VELSIPITY^® for the treatment of patients with moderately to severely active UC in December 2024.

VELSIPITY^® is an effective and convenient, once-daily, oral treatment for adult patients with moderately to severely active UC that has already been approved in the U.S., E.U., and other countries by Everest's licensing partner, Pfizer. The approval of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12). Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod. Etrasimod has been included in the 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. VELSIPITY^® has already been introduced to hospitals in the Greater Bay Area through the 'Hong Kong and Macau Medicine and Equipment Connect' policy. With the NDA for VELSIPITY^® officially accepted by the NMPA, we look forward to expanding patient access to this therapy."

Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's Asia clinical trial said: "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. UC is a chronic, relapsing, non-specific inflammatory disease, and 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."

As a core product of Everest Medicines, etrasimod is an innovative and advanced therapy that provides the chance for rapid onset of action, clinical remission and mucosal healing through an oral, once-daily regimen. Etrasimod has been commercially launched in Singapore and Macau in 2024. As Everest's third commercialized product, VELSIPITY^® has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC. It is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. Additionally, Everest has launched the construction project at its Jiashan factory to support the local production for VELSIPITY^®.