Everest Medicines Expands in Asia: VELSIPITY® Approved in Hong Kong

Everest Medicines (HKEX 1952.HK), a leading biopharmaceutical company, has announced the acceptance of its New Drug Application (NDA) for VELSIPITY® (etrasimod) in Hong Kong. This approval marks a significant milestone in the company's regional expansion strategy and solidifies its commitment to delivering innovative therapies to patients in need.

VELSIPITY®, an oral, once-daily treatment for moderately to severely active ulcerative colitis (UC), has already been approved in several markets, including the United States, European Union, and Macau. The drug's unique mechanism of action, targeting sphingosine 1-phosphate (S1P) receptors, has demonstrated efficacy and a favorable safety profile in clinical trials.

The Hong Kong approval further expands Everest Medicines' presence in Asia, where the prevalence of UC is projected to double by 2030. With this approval, Everest Medicines now has regulatory clearance for VELSIPITY® in five markets, including Hong Kong, Macau, Singapore, the United States, and the European Union. This regional expansion strategy allows Everest Medicines to tap into the growing market for advanced therapies in Asia and capture a larger share of this expanding market.

Everest Medicines' CEO, Rogers Yongqing Luo, expressed his excitement about the approval, stating, "The acceptance of the NDA for VELSIPITY® in Hong Kong is a testament to our commitment to bringing innovative therapies to patients in need. We are committed to expeditiously delivering these therapies and will continue to explore innovative ways to improve accessibility."

The Hong Kong approval is also a significant step towards Everest Medicines' plans to submit the NDA for VELSIPITY® to China's National Medical Products Administration (NMPA) by the end of 2024. This submission will enable Everest Medicines to expand its reach into the mainland China market and further enhance its position in the Asia-Pacific region.



In terms of market size, the Hong Kong UC market is estimated to be HK$200 million ($25.5 million USD) based on the prevalence of UC and the drug's pricing. This contributes to Everest Medicines' overall revenue strategy, as VELSIPITY® is a core product in their autoimmune disease portfolio. The drug's convenient, once-daily oral treatment addresses a significant unmet need in the region, positioning Everest Medicines to capture market share and drive revenue growth.



In conclusion, Everest Medicines' approval of VELSIPITY® in Hong Kong signals its commitment to regional expansion and addressing the growing need for advanced therapies in Asia. With a strong pipeline and a focus on autoimmune diseases, Everest Medicines is well-positioned to capitalize on the expanding market and drive revenue growth in the Asia-Pacific region.