Everest Medicines (HKEX 1952.HK, “Everest”, or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the National Medical Products Administration (NMPA) of China has officially accepted the New Drug Application (NDA) for VELSIPITY(R) (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC). VELSIPITY(R) is an effective and convenient, once-daily, oral treatment for patients with moderately to severely active UC.VELSIPITY(R) was officially approved by the Pharmaceutical Administration Bureau of Macau in April 2024, and was introduced in the Greater Bay Area in October through the "Hong Kong and Macau Medicine and Equipment Connect" policy. VELSIPITY(R) is now the third commercialized product of Everest Medicines.
“We are pleased to see that the NDA for VELSIPITY(R) has been officially accepted in mainland China., "said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “If approved, China would represent the third approval of VELSIPITY(R) in Everest’s licensed territories for the drug after Macau and Singapore. By 2030, the number of patients with UC in China is expected to more than double compared to 2019, reaching approximately 1 million, with a significant unmet need for innovative therapies. We are committed to expanding access to VELSIPITY(R), with the goal of benefiting more patients living with moderately to severely active ulcerative colitis. "
" As the only drug that has been proven to be effective in UC patients with moderately to severely active isolated proctitis in global Phase III clinical trials, the official acceptance of the NDA for VELSIPITY(R) in mainland China brings hope to many patients,” said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial.” As a next-generation S1P receptor modulator, VELSIPITY(R) can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. In addition, the data from the largest-scale Phase III clinical trial of moderately to severely active UC patients in Asia once again confirmed the favorable efficacy and safety profile of VELSIPITY(R). We look forward to the early approval of this drug to benefit more patients."
As a key product for Everest Medicines, VELSIPITY(R) was approved in Macau, China and Singapore in the first half of this year. Its first prescription has been issued on December 11th at Kiang Wu Hospital in Macau, which marks the official beginning of this new therapy benefiting patients across Asia. In addition, Everest Medicines has also submitted and had its NDA officially accepted for VELSIPITY(R) in Hong Kong. With the support of the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY(R) has also been officially approved to enter the Greater Bay Area and can be used in four designated medical institutions which are the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Hospital.
Click here to continue