EVEREST MED announced that China's National Medical Products Administration has approved the New Drug Application for VELSIPITY® (argenine etrasimod tablets) for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response, loss of response, or intolerance to conventional therapies or biologics. As a next-generation, highly selective sphingosine-1-phosphate receptor modulator, VELSIPITY® is an oral, once-daily treatment that offers rapid onset of action, potent and deep mucosal healing, and a favorable safety profile, providing a new first-line treatment option for adults with UC.
The approval is based on results from the Asia-focused, multi-center Phase III ENLIGHT UC study and the global Phase III ELEVATE UC program. The ENLIGHT UC study is the largest Phase III registration clinical study completed to date in Asian patients with moderate to severe active UC, involving a total of 340 patients. In both the 12-week induction and 40-week maintenance treatment periods, the VELSIPITY® treatment group demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints, with a well-tolerated safety profile consistent with previous studies. The ELEVATE UC 52 and ELEVATE UC 12 studies, which are randomized, double-blind, placebo-controlled trials, further confirmed the favorable benefit-risk profile of VELSIPITY®.
The approval of VELSIPITY® marks a significant milestone for the company in establishing a leading position in the autoimmune disease领域. The company will actively prepare for the commercial launch of VELSIPITY® to bring this therapy to patients in China as soon as possible and will work towards its inclusion in the National Reimbursement Drug List. This approval is also a key part of the company's 2030 development strategy, which emphasizes a dual-drive approach combining business development collaborations and internal R&D to create definitive value through commercialization and growth value through research.
The company will continue to strengthen its advantages in core therapeutic areas, advance the development and commercialization of innovative drugs, and build a sustainable, global innovative biopharmaceutical company. Its focus areas include renal diseases, autoimmune diseases, critical care, cardiovascular diseases, and ophthalmology. By 2030, the company aims to build a high-value product portfolio and expand into other promising niche areas.
In terms of commercial platform development, the company has already commercialized three products and is building a comprehensive commercial system with full lifecycle management capabilities. The company plans to achieve revenues exceeding RMB 10 billion by 2028 and over RMB 15 billion by 2030, with a compound annual growth rate of over 50% projected between 2025 and 2030, and sustained growth above 15% thereafter. The number of commercialized products is expected to increase to more than 20.
Regarding global capability building, the company has initiated a globalization strategy to enhance its international regulatory and clinical development capabilities. By 2030, it plans to accelerate international development through a dual-engine growth model of "out-licensing + commercialization." The 2030 strategy represents a major milestone in the company's journey to the forefront of global biopharmaceuticals. Over the next five years, the company will focus on the dual-drive strategy, leveraging scientific and market insights to build a diversified product portfolio in strategic areas. It plans to introduce 3 to 5 mid-to-late-stage blockbuster products annually, aiming for a total of over 20 high-value assets by 2030, contributing RMB 6 billion in revenue that year and approximately RMB 30 billion by 2035. Through this strategic layout, the company is committed to maintaining leadership in core therapeutic areas and innovative drug R&D, building a sustainable global biopharmaceutical enterprise, and striving to become a leading comprehensive biopharmaceutical company worldwide.