SHANGHAI, Dec. 17, 2024 /PRNewswire/ -- 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® (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC). VELSIPITY® is an effective and convenient, once-daily, oral treatment for patients with moderately to severely active UC.
VELSIPITY® 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® is now the third commercialized product of Everest Medicines.
"We are pleased to see that the NDA for VELSIPITY® has been officially accepted in mainland China.," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "If approved, mainland China would represent the third approval of VELSIPITY® in Everest's licensed territories after Macau (China) and Singapore. By 2030, the number of patients with UC in mainland 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®, 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® 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® 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®. We look forward to the early approval of this drug to benefit more patients."
As a key product for Everest Medicines, VELSIPITY® 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 (China), 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® in Hong Kong SAR. With the support of the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® 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.
VELSIPITY® has been recently included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area ("the Catalog"), published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. With the inclusion of VELSIPITY® in the Catalog, we expect to accelerate its availability in all 45 designated medical institutions under the Connect Policy.
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. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau (China) for VELSIPITY® in ulcerative colitis.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.