China Accepts New Drug Application for VELSIPITY® to Treat Ulcerative Colitis

Shanghai, China – On December 17, 2024, Everest Medicines, a biopharmaceutical firm known under the HKEX code 1952.HK, announced a significant milestone in its journey to bring advanced medical solutions to the Asian market. The company has received official acceptance from China's National Medical Products Administration (NMPA) for its New Drug Application (NDA) for VELSIPITY® (etrasimod). This drug is intended for patients suffering from moderately to severely active ulcerative colitis (UC) and offers a simplified, once-daily oral treatment option.

VELSIPITY® had earlier gained approval from the Pharmaceutical Administration Bureau of Macau in April 2024. By October, the drug was introduced to the Greater Bay Area under the "Hong Kong and Macau Medicine and Equipment Connect" initiative. This makes VELSIPITY® the third product from Everest Medicines to reach commercial status.

Rogers Yongqing Luo, CEO of Everest Medicines, expressed satisfaction with the progress of the NDA for VELSIPITY® in China, highlighting the company's commitment to expanding the drug's reach. Luo emphasized the increasing prevalence of UC in China, with projections suggesting the patient population could surpass one million by 2030. This growth underscores the pressing need for new and effective treatments. The approval of VELSIPITY® in China would follow its acceptance in Macau and Singapore, marking significant progress in the company's expansion plan across its licensed territories.

Professor Wu Kaichun from the First Affiliated Hospital of AFMU, who led the Asian clinical trial for etrasimod, noted the promising future of VELSIPITY® in addressing unmet medical needs. As the only globally proven drug for patients with moderately to severely active isolated proctitis, VELSIPITY® provides hope for many. Its mechanism as a next-generation S1P receptor modulator enables corticosteroid-free remission, mucosal healing, and rapid symptom relief. The largest Phase III clinical trial in Asia validated its efficacy and safety, reinforcing the potential benefits for patients upon its anticipated approval.

VELSIPITY® has already received approval in Macau, China, and Singapore earlier this year. The first prescription was dispensed on December 11 at Kiang Wu Hospital in Macau, marking the therapy's initial impact on patient care in Asia. Additionally, the NDA submission for VELSIPITY® in Hong Kong has been officially accepted. Under the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® has been cleared to enter the Greater Bay Area, making it accessible in key medical institutions, including the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University, and Guangzhou United Family Hospital.

The drug's inclusion in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province, under the Guangdong-Hong Kong-Macau Greater Bay Area initiative, further cements its availability across the region. This inclusion is anticipated to accelerate VELSIPITY®’s deployment in all 45 designated medical facilities supported by the Connect Policy.

VELSIPITY® operates as a once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator, selectively targeting S1P receptor subtypes 1, 4, and 5. It has gained regulatory approval across numerous global regions, including the US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel, and Macau, China, for the treatment of ulcerative colitis.

Everest Medicines continues to establish itself as a leader in the biopharmaceutical industry, dedicated to discovering, developing, and delivering transformative pharmaceuticals and vaccines. With a management team possessing extensive experience from both international and local Chinese pharmaceutical entities, the company is well-positioned to address critical unmet medical needs in Asia. Everest Medicines’ portfolio includes potential first-in-class or best-in-class therapies across renal diseases, infectious diseases, and autoimmune disorders.