AUS
NZ
UK
CA
USA
FRA
GER
ESP
ITA
NLD
PRT
SWE
GRC
IND
POL
BRA
ZAF
RUS
CHN
UAE
SHANGHAI, Oct. 25, 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, 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 Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University, two of the medical institutions designated by the "Hong Kong and Macau Medicine and Equipment Connect" policy in the Greater Bay Area. Subsequently, VELSIPITY® will be introduced in other qualified hospitals under the connect policy.
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 UC. 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. 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.
"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." Said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Everest Medicines is committed to expeditiously delivering innovative therapies to patients. Moving forward, we will keep leveraging our strengths and exploring innovative ways to improve the accessibility of these therapies. 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."
VELSIPITY® was developed by Arena Pharmaceuticals, which was acquired by Pfizer in 2022. Everest Medicines obtained exclusive rights to develop, produce, and commercialize VELSIPITY® in Greater China and South Korea from Arena as early as 2017. As a core product in the field of autoimmune diseases for Everest Medicines, VELSIPITY® was successively approved in Macau and Singapore in the first half of this year and was approved in the United States and the European Union in October last year and February this year, respectively. In addition, Everest Medicines recently submitted an new drug application for VELSIPITY® in Hong Kong, China.
VELSIPITY® is the first and only advanced oral UC therapy approved for use in patients 16 years of age or older in the EU, and the ELEVATE UC 52 and ELEVATE UC 12 were the only studies of advanced therapies for UC to include patients with isolated proctitis. In the results of the Asian multi-center Phase 3 clinical trial of VELSIPITY® for the treatment of moderately to severely active UC announced in July this year, VELSIPITY® achieved positive topline data results in both the induction and maintenance treatment periods, with good safety profile, and is convenient to take once a day, providing further solid scientific basis and support for the wide application of the drug in clinical practice.
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.
