Everest Medicines’ New Drug Application for Etrasimod Accepted in Taiwan, Marking Another Milestone in Asia Market Access

HONG KONG, Aug 14, 2025 – (ACN Newswire) –Everest Medicines (HKEX 1952. HK, “Everest”) today revealed that the Taiwan Food and Drug Administration (TFDA) has actually formally accepted the New Drug Application (NDA) for VELSIPITY(R) (etrasimod) for the treatment of clients with reasonably to seriously active ulcerative colitis (UC).

Structure on previous approvals in Singapore, Hong Kong SAR, and Macao SAR, in addition to NDA approval in South Korea, this marks substantial development in the commercialization of VELSIPITY(R) throughout Asia. In December 2024, China’s National Medical Products Administration (NMPA) formally accepted the NDA for VELSIPITY(R).

As a next-generation selective S1P receptor modulator, once-daily oral etrasimod shows robust effectiveness throughout numerous endpoints, consisting of scientific remission, mucosal recovery, endoscopic normalization and histological remission. Its scientific worth has actually been robustly shown in numerous worldwide Phase III research studies, consisting of ELEVATE UC 52, ELEVATE UC 12 and ENLIGHT (ES101002) research studies.

“The NDA approval for VELSIPITY(R) in Taiwan, China marks another crucial development in our commercialization path throughout Asia. As the variety of UC clients in Asia continues to increase, there stays a substantial unmet medical requirement. In China alone, there were around 800,000 clients with UC in 2024, and the number is approximated to reach 1 million by 2030. UC clients deal with the double obstacles of long-lasting treatment and keeping lifestyle.” stated Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “This NDA approval highlights the scientific worth of VELSIPITY(R). We stay dedicated to speeding up access to this ingenious treatment in Mainland China and other Asian markets, supporting long-lasting illness management while boosting clients’ lifestyle.”

The medical part sent to TFDA is primarily based upon arise from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT research study (ES101002). The ELEVATE UC Phase 3 registrational program assessed the security and effectiveness of etrasimod 2 mg once-daily on medical remission in UC clients with reasonably to seriously active UC who had actually formerly stopped working or were intolerant to a minimum of one standard, biologic, or Janus kinase (JAK) inhibitor treatment. Both research studies accomplished all main and crucial secondary effectiveness endpoints, with a beneficial security profile constant with previous research studies of etrasimod.

The ENLIGHT research study (ES101002) performed by Everest, is a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian nations, consisting of China Mainland, China Taiwan and South Korea. This is the biggest Phase 3 trial of reasonably to significantly active ulcerative colitis in Asia finished to date, with 340 qualified topics randomized to treatment with etrasimod or placebo. The outcomes show that treatment with etrasimod 2 mg led to a scientifically significant and statistically considerable enhancement in the main and all secondary endpoints. These findings supply strong proof supporting using etrasimod in adult Asian clients with reasonably to seriously active ulcerative colitis.

As Everest’s 3rd commercialized item, VELSIPITY(R) has actually been formally authorized by the Guangdong Provincial Medical Products Administration for adult clients with reasonably to significantly active UC. It is now offered at medical organizations designated under the Connect Policy in the Greater Bay Area. In addition, Everest has actually introduced a factory building and construction task at its Jiashan website to support regional production of VELSIPITY(R).

Subject: Press release summary