EVEREST MED(01952): Visionsen's new drug application for the treatment of moderate to severe ulcerative colitis in adult patients has been approved in China.

EVEREST MED(01952) announced that the China National Medical Products Administration (NMPA) has approved the new drug application for VELSIPITY (arginine aquivumode tablets, VELSIPITY) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients who have inadequate response, no response, or intolerance to traditional treatment or biologics in China. As a new generation of highly selective sphingosine-1-phosphate (S1P) receptor modulator, VELSIPITY is taken orally once daily, providing rapid onset of action and strong deep mucosal healing, with good safety characteristics, offering a new first-line treatment option for adult ulcerative colitis patients. The approval of VELSIPITY is based on the results of the Asia multi-center Phase III registration clinical trial ENLIGHT UC study (ES101002) and the global Phase III registration study ELEVATE UC (including ELEVATE UC 52 and ELEVATE UC 12 studies). The ENLIGHT UC study is the largest Phase III registration clinical trial of Asian moderate to severe active ulcerative colitis patients to date, with a total of 340 patients enrolled. In the 12-week induction period and 40-week maintenance period, the VELSIPITY treatment group achieved statistical significance and clinical significance in all major and minor efficacy endpoints, and showed good safety, with safety features consistent with previous studies. The ELEVATE UC 52 and ELEVATE UC 12 studies in the Phase III registration study of ELEVATE UC further demonstrated the good benefit-risk ratio of VELSIPITY. The approval of the new drug application for VELSIPITY is also a milestone for the company to establish its leading advantage in the field of autoimmunity. The company will actively prepare for the commercial launch of VELSIPITY and bring this therapy to domestic patients as soon as possible, while actively promoting its inclusion in the national medical insurance list. The approval of the new drug application for VELSIPITY is also an important part of the company's development strategy for 2030, which clearly states the dual-drive approach of "BD cooperation + self-research" to achieve commercial value creation with certainty and research development (R&D). The company will continue to consolidate its advantages in core treatment areas, advance innovation drug R&D and commercialization, and build a sustainable growth global innovative biopharmaceutical company. In the disease field, the company focuses on core areas such as nephrology, autoimmune diseases, acute and severe diseases, cardiovascular and ophthalmology, by introducing innovative assets and advancing independent research and development in parallel, forming a high-value product portfolio by 2030, and expanding into other blue ocean areas. In terms of commercialization platform construction, the company has laid out three commercial products and is actively establishing a full-channel commercialization system and commercialization capability throughout the drug lifecycle. The company plans to achieve a revenue scale of over RMB 10 billion by 2028, and revenue over RMB 15 billion by 2030 (including existing pipeline sales revenue of about RMB 9 billion and new pipeline sales revenue of about RMB 6 billion); The annual compound growth rate of revenue is expected to exceed 50% from 2025 to 2030, and remain over 15% after 2030. At the same time, the number of commercialized products will increase to more than 20, including NIFUKANG, VELSIPITY, EIJIA, LERIBO, and MT1013. In terms of global development capabilities, the company has launched a global strategy to advance the registration and clinical development capabilities globally. By 2030, the company plans to accelerate international development through the dual engine of "overseas authorization + commercialization". The 2030 development strategy marks an important milestone for the company to move towards the forefront of global biopharmaceuticals. Over the next five years, the company will focus on the dual-drive approach of "BD cooperation + self-research", relying on scientific and market insights to promote the formation of N+X product combinations in strategic areas and seize opportunities for blue ocean big products. The company plans to introduce 3 to 5 mid-to-late stage blockbuster products each year through the established business expansion capabilities, achieving peak sales for each product within three years of medical insurance. Over the next five years, the company plans to introduce more than 20 high-value assets, contributing RMB 6 billion in revenue by 2030, and achieving revenue of approximately RMB 30 billion by 2035. Through this strategic layout, the company is committed to maintaining its leading position in core treatment areas and innovative drug R&D, building a sustainable growth global innovative biopharmaceutical company, and striving to become a leading comprehensive biopharmaceutical company globally.