Everest Medicines Announces the Inclusion of VELSIPITY® 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

Shanghai, China – December 16, 2024 - 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 VELSIPITY® (etrasimod) has been 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 (hereinafter referred to as “the Catalog”), published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province.

Products in the Catalog will be managed in accordance with the “Administrative Regulations on the Pharmaceutical and Medical Devices of Nine Municipalities in Guangdong Province in Guangdong-Hong Kong-Macau Greater Bay Area Imported from Hong Kong and Macau” (hereinafter referred to as “the Regulations”). The Regulations came into effect on December 1, 2024, aiming to legislate the implementation of the "Hong Kong and Macau Medicine and Equipment Connect" policy (hereinafter referred to as “the Connect Policy”), address challenges in the management of Hong Kong and Macau drugs and medical devices, and promote the high-level development of a healthy Bay Area. The list of designated medical institutions for the Connect Policy has recently been expanded to 45, achieving full coverage across the 9 municipalities in the Greater Bay Area.

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, non-specific inflammatory disease, and as disease progresses, the risk of disability and colorectal cancer incidence rises. Since October of this year, VELSIPITY® has been available 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. With the inclusion of VELSIPITY® in the Catalog, we expect to accelerate its availability in all 45 designated medical institutions under the Connect Policy.

“By 2030, the number of patients with UC is projected to more than double compared to 2019, reaching approximately 1 million, highlighting a significant unmet need for innovative therapies," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “The inclusion of VELSIPITY® in the Catalog demonstrates its status as an innovative therapy with proven clinical value, offering both efficacy and safety. This will help address the urgent demand for innovative therapies among UC patients in mainland China. We also plan to submit a New Drug Application for VELSIPITY® in Mainland China soon to enhance its accessibility. "

As a core product for Everest Medicines, VELSIPITY® can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. 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, providing further solid scientific basis and support for the wide application of the drug in clinical practice.

VELSIPITY® was approved in Macau and Singapore in the first half of this year. In addition, Everest Medicines has also submitted a new drug application for VELSIPITY® in Hong Kong, China which was officially accepted on December 2, 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 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.

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