Workflow
全球化生物制药战略
icon
Search documents
云顶新耀(01952):维适平®用于治疗成人患者中重度溃疡性结肠炎的新药上市申请在中国获批
智通财经网· 2026-02-06 04:14
Core Viewpoint - The approval of VELSIPITY® (Arginine Acquimod Tablets) by the NMPA marks a significant milestone for the company in establishing its leading position in the autoimmune field, providing a new first-line treatment option for adult patients with moderate to severe active ulcerative colitis who have inadequate response to traditional therapies or biologics [1][3] Group 1: Product Approval and Clinical Research - VELSIPITY® is a next-generation high-selectivity sphingosine-1-phosphate (S1P) receptor modulator, administered once daily, demonstrating rapid onset and strong mucosal healing efficacy with good safety characteristics [2] - The approval is based on results from the ENLIGHT UC study, the largest Phase III registration clinical trial for moderate to severe active ulcerative colitis patients in Asia, involving 340 patients, achieving statistical significance and clinical relevance in all primary and secondary efficacy endpoints [2] - The ELEVATE UC Phase III studies further validated the benefit-risk profile of VELSIPITY®, with ELEVATE UC 52 and ELEVATE UC 12 being randomized, double-blind, placebo-controlled trials [2] Group 2: Commercialization Strategy - The company is preparing for the commercialization of VELSIPITY® and aims to expedite its availability to domestic patients while actively promoting its inclusion in the national medical insurance catalog [3] - The approval aligns with the company's 2030 development strategy, which emphasizes a dual approach of "BD collaboration + self-research" to create certain value through commercialization and growth through research and development [3][5] - The company plans to establish a comprehensive commercialization system and aims to achieve revenue exceeding 10 billion RMB by 2028 and over 15 billion RMB by 2030, with a projected compound annual growth rate of over 50% from 2025 to 2030 [4] Group 3: Future Growth and Globalization - The 2030 development strategy signifies a critical milestone for the company in advancing to the forefront of global biopharmaceuticals, focusing on a product portfolio that captures blue ocean opportunities [5] - The company intends to introduce 3 to 5 late-stage blockbuster products annually and aims to contribute 6 billion RMB in revenue from over 20 high-value assets by 2030, with a long-term goal of approximately 30 billion RMB by 2035 [5] - The company is also initiating a globalization strategy to enhance its global registration and clinical development capabilities, aiming for accelerated international growth through a dual engine of "overseas licensing + commercialization" [4]