Everest Medicines Announces Acceptance of VELSIPITY® New Drug Application in Macau

-- Macau is on course to become the first of Everest's Asian territories to get etrasimod approval

-- Can provide access to patients in China's Greater Bay area and rest of Asia

SHANGHAI, March 11, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced the Pharmaceutical Administration Bureau of the Macau 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 ulcerative colitis (UC) that has already been approved in the U.S., E.U., and Canada by Everest's licensing partner, Pfizer.

"Autoimmune disease is a key area of focus and a significant potential growth driver for our company," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We are pleased that the VELSIPITY^® NDA submission has now been accepted in Macau, which could become the first of our licensing territories in Asia to get approval. As we have witnessed with the successful commercial launch of Nefecon^® in Macau, patients are eager to gain access our innovative drugs. We also aim to take advantage of the preferential policies in the Greater Bay area to accelerate drug accessibility for mainland China. The company now awaits the 52-week data from our Phase 3 Asia clinical trial and plans to submit the NDA for NMPA approval in mainland China this year to benefit more Chinese patients as soon as possible."

"This is an important milestone for etrasimod in Asia and is expected to benefit patients in Greater China in the near future. 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's Asia clinical trial. "We hope China and other Asian countries can obtain approvals as soon as possible to benefit more patients."

The number of UC patients in China is expected to more than double from 2019 to reach approximately one million by 2030, highlighting the need for novel treatments for the disease.

Everest is conducting a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries and regions, including mainland China, China Taiwan and South Korea. Patients with inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy were randomized to receive etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment. Etrasimod treatment resulted in a clinically meaningful and statistically significant improvement in the primary endpoint and all key secondary and other secondary endpoints (including mucosal healing, symptomatic remission and endoscopic normalization) after the 12-week induction treatment period. In general, treatment with etrasimod 2mg was well tolerated. The safety profile was consistent with previous etrasimod studies and no new safety findings were observed. Patients who responded to induction treatment were then re-randomized to receive 2mg once-daily etrasimod or placebo maintenance treatment for 40 weeks. The data for maintenance period is expected for readout in 2H 2024.

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 applications for VELSIPITY in ulcerative colitis have been submitted to additional countries including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey, and the UK.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products 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 commercial operations. Everest Medicines has built a portfolio of global first-in-disease or best-in-class molecules. The Company's therapeutic areas of interest include renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com

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