Everest Medicines Announces the Acceptance and Priority Review of VELSIPITY(R) Manufacturing Localization Application by the Center for Drug Evaluation of China's NMPA, Driving Continued Commercial Momentum

Hong Kong, Oct 2, 2026 - (ACN Newswire) - Everest Medicines recently announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the application for localized manufacturing for VELSIPITY(R) (etrasimod arginine tablets) and granted Priority Review. Localized manufacturing of VELSIPITY(R) is expected to begin in 2027, further enhancing supply capacity and supply security in China and across the Asia-Pacific region. The acceptance marks progress in the Company’s planned commercialization of VELSIPITY(R).

The VELSIPITY(R) localized production project has been progressing steadily since its launch at the Company’s global manufacturing facility in Jiashan in March 2025, with ongoing efforts focused on technology transfer, process optimization and preparations for localized manufacturing. Upon commencement of production, the facility is expected to have an annual production capacity of up to 50 million tablets, helping to strengthen supply stability, reduce manufacturing costs and improve operational efficiency, while supporting the commercialization of VELSIPITY(R).

VELSIPITY(R) was approved by NMPA in February, 2026, for the treatment of adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. As a next-generation highly selective S1P receptor modulator, VELSIPITY(R) offers the potential for rapid onset of action, and long-lasting clinical remission and mucosal healing through an oral, once-daily regimen for adult patients with moderately to severely active UC. The first prescription of VELSIPITY(R) in China was issued in March 2026, making its entry into clinical use. Alongside its rapid commercialization, the Company is actively participating in negotiations for the inclusion of VELSIPITY(R) in the National Reimbursement Drug List (NRDL).

VELSIPITY(R) has been approved in several territories licensed to Everest Medicines, including mainland China, Hong Kong SAR, Macao SAR, Singapore, and South Korea, and is expected to receive NDA approval in Taiwan, China in the second half of 2026.

On the clinical front, Ulcerative colitis (UC) is a chronic, relapsing, non-specific inflammatory bowel disease. In China, the incidence and prevalence of UC continue to increase, with a clear trend toward younger patients. The patient population is projected to increase from approximately 0.98 million in 2025 to 1.50 million by 20311,2.

Multiple studies of VELSIPITY(R) presented at the 21st Congress of the European Crohn’s and Colitis Organization (ECCO 2026) and the 14th Annual Meeting of the Asian Organization for Crohn’s and Colitis (AOCC 2026) further supported its clinical profile. The data demonstrated sustained efficacy with continuous treatment for up to 3 years3. Durable benefit was observed in patients who had received only 5-ASA/thiopurine treatment, and in biologic-experienced patients4,5. Benefit was also demonstrated in patients with mildly to moderately active UC6, with favorable long-term safety and tolerability maintained for up to 5 years of treatment7. These findings further strengthen the clinical evidence base of VELSIPITY(R).

The clinical value of VELSIPITY(R) has been recognized in leading international clinical guidelines. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline in December 2024 as a first-line treatment for ulcerative colitis, VELSIPITY(R) was also included in the 2025 American College of Gastroenterology (ACG) Clinical Guideline, the 2026 Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines and the 2026 European Crohn's and Colitis Organization (ECCO) Guidelines.

Everest Medicines has a commercial-scale global manufacturing site in Jiashan, Zhejiang Province. It has established a complete GMP production quality management system complying with Chinese, EU and WHO standards and holds the manufacturing license.

Localized manufacturing is expected to further enhance the commercial potential of VELSIPITY(R) by improving supply reliability and operational efficiency in China. Supported by Everest Medicines’ A2MS commercial operating system and lean management capabilities, the localized production of VELSIPITY(R) will strengthen the foundation for its continued expansion in China and further build the Company’s commercial capabilities in autoimmune diseases, supporting its long-term growth.

Reference
1. Shao B, et al. Front Public Health. 2022 Oct 25;10:1032679.
2. Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727.
3. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.774.
4. B E Sands, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1105.
5. C Zheng, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1046.
6. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.100.
7. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1256.