Everest Medicines has announced the launch of VELSIPITY® (etrasimod) in the Guangdong-Hong Kong-Macau Greater Bay Area for patients with moderately to severely active ulcerative colitis (UC). This launch is made possible through the "Hong Kong and Macau Medicine and Equipment Connect" policy, marking a significant step in expanding access to innovative therapies in mainland China.
VELSIPITY® has been approved by the Guangdong Provincial Medical Products Administration and will initially be available at Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University, both designated medical institutions under the connect policy. The drug is an oral, once-daily treatment indicated for patients aged 16 and above with moderately to severely active UC.
Addressing Unmet Needs in Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing inflammatory disease. The incidence of UC is rising, and as the disease progresses, the risk of disability and colorectal cancer increases. By 2030, the number of UC patients in China is projected to more than double compared to 2019, reaching approximately 1 million. This escalating prevalence underscores a substantial unmet need for innovative therapies.
Rogers Yongqing Luo, CEO of Everest Medicines, stated, "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." He further added, "Everest Medicines is committed to expeditiously delivering innovative therapies to patients and will keep leveraging our strengths and exploring innovative ways to improve the accessibility of these therapies."
Regulatory Approvals and Clinical Data
VELSIPITY® received approval from the Pharmaceutical Administration Bureau of Macau in April 2024. It has also been approved in the United States, the European Union, Singapore and other countries. Everest Medicines holds exclusive rights to develop, produce, and commercialize VELSIPITY® in Greater China and South Korea, acquired from Arena Pharmaceuticals (now a part of Pfizer) in 2017.
In July of this year, Everest Medicines announced positive topline data from an Asian multi-center Phase 3 clinical trial of VELSIPITY® for UC. The trial demonstrated that VELSIPITY® achieved positive results in both induction and maintenance treatment periods, with a favorable safety profile and the convenience of once-daily oral administration. These results provide a solid scientific foundation for the drug's clinical application.
Future Plans for VELSIPITY®
Everest Medicines plans to submit a new drug application (NDA) for VELSIPITY® in mainland China by the end of this year. This submission aims to further enhance the drug's accessibility and benefit a larger population of patients suffering from ulcerative colitis.
About VELSIPITY® (etrasimod)
VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. It has received regulatory approvals in multiple regions for the treatment of ulcerative colitis.
