Everest Medicines Announces Acceptance of VELSIPITY® New Drug Application in Hong Kong

SHANGHAI,Dec. 2, 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 Department of Health of the Government of the Hong Kong Special Administrative Region,China, has accepted Everest's New Drug Application (NDA) for VELSIPITY®(etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis.  VELSIPITY® is an effective and convenient, once-daily, oral treatment for patients with moderately-to-severely active UC that has already been approved in the U.S. and E.U., and other countries, by Everest's licensing partner, Pfizer. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region,Chinahas approved the NDA for VELSIPITY® in April of this year and was implemented in theGuangdong-Hong Kong-Macau Greater Bay Area this October through the"Hong Kongand Macau Medicine and Equipment Connect"policy.

"Autoimmune disease is a core focus and a significant growth driver for our company. The number of UC patients inChinais projected to double from 2019 to 2030 to approximately one million, highlighting the urgent need for novel treatments."said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines."Previously, VELSIPITY®has already been approved inMacau,China, and was implemented in the Greater Bay Area through the connect policy. The company also plans to submit the NDA for approval byChina'sNational Medical Products Administration (NMPA) this year, with the aim of benefiting more Chinese patients as soon as possible."

"This is an important advancement for etrasimod, bringing hope to patients inHong Kong, China. This new-generation S1P receptor modulator is an oral, once-daily treatment that 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 who is the principal investigator for etrasimod'sAsiaclinical trial."We hopeChinaand other Asian countries can obtain approvals as soon as possible to benefit more patients."

The acceptance of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

Everest conducted a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainlandChina, China Taiwan and South Korea. This is the largest Phase 3 trial of moderately-to-severely active ulcerative colitis inAsiacompleted to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The previously announced results of the induction period indicate that the clinical remission rate for patients treated with etrasimod 2mg was 25.0%, compared to 5.4% for those treated with placebo (difference 20.4%, p<0.0001). Compared to the placebo group, patients treated with etrasimod demonstrated significant clinical and statistically significant improvements in all key secondary endpoints. Subsequently, the topline results from maintenance period released in July of this year confirmed that after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed. The results of the maintenance period will be released at an international academic conference.

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,IsraelandMacau,Chinafor 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 atwww.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.

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SOURCE Everest Medicines