SHANGHAI, Dec. 12, 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 first prescription of VELSIPITY® (etrasimod) has been issued on December 11th at Kiang Wu Hospital in Macau. It is also the first prescription issued for VELSIPITY® within Everest Medicines' licensed territories in Asia following its approval, marks the official beginning of this new therapy benefiting patients across Asia.
VELSIPITY® is an innovative advanced therapy that was officially approved by the Pharmaceutical Administration Bureau of Macau in April 2024. It is an oral treatment taken once daily for the treatment of patients aged 16 and above with moderately to severely active ulcerative colitis (UC). UC is a chronic, relapsing, idiopathic inflammatory disease, and with prolonged disease duration, the risk of disability and colorectal cancer incidence continues to rise.
"As a next-generation S1P receptor modulator, VELSIPITY® can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief." said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU, the principal investigator for etrasimod's Asia clinical trial." The recently announced results of the Asian multicenter Phase III clinical study for induction and maintenance periods further confirm the clinical advantages of VELSIPITY®. We look forward to VELSIPITY® being approved in other regions of Asia soon to benefit more patients."
"The first prescription of VELSIPITY® in Macau marks another milestone in the commercialization process of Everest Medicines." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "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. Following its approval in Macau this April, VELSIPITY®, the third commercialized product of Everest Medicines, will bring new treatment options to more patients with moderate to severely active UC. We plan to have VELSIPITY® submitted for new drug application in mainland China by the end of this year, further enhancing its accessibility and benefiting more patients."
In the results of the multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of subjects with moderately to severely active UC, which were announced in July this year, etrasimod achieved positive results in both the induction and maintenance phases of treatment, with good safety, and the convenience of once-daily oral administration, further providing a solid scientific basis and support for the broad application of the drug in clinical practice. In October, the complete induction phase data of the study were presented at the 32nd United European Gastroenterology Week (UEGW 2024), showing that all primary and key secondary efficacy endpoints in the etrasimod treatment group achieved statistically significant and clinically meaningful improvements compared to the placebo group at week 12: the treatment differences between the etrasimod group and the placebo group in clinical remission rate, endoscopic improvement rate, and clinical response rate reached 20.4%, 28.6%, and 32.0%, respectively.
VELSIPITY® was approved in the United States and the European Union in October last year and February this year, respectively. As a core product for Everest Medicines, VELSIPITY® was successively approved in Macau and Singapore in the first half of this year. Everest Medicines has also submitted a new drug application for VELSIPITY® in Hong Kong, China which has been officially accepted.
In October of this year, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® has officially been approved for patients with moderately to severely active ulcerative colitis (UC) by the Guangdong Provincial Medical Products Administration and can first be used in the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Healthcare, four of the medical institutions designated by the Connect Policy in the Greater Bay Area. Subsequently, VELSIPITY® will be introduced in other qualified hospitals 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 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.
source: Everest Medicines
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