Core Viewpoint - Yunding Xinyao announced the approval of its new drug, Weishiping (Arginine Acumod Tablets), for the treatment of moderate to severe active ulcerative colitis in adults who have insufficient response to traditional therapies or biologics [1] Group 1: Drug Approval and Clinical Trials - The approval is based on the results of the ENLIGHTUC study, a multi-center Phase III registration clinical trial in Asia, and the global Phase III registration study ELEVATEUC [1] - The ENLIGHTUC study included 340 patients and achieved statistical significance with good safety profiles during treatment [1] Group 2: Commercialization and Strategic Goals - The company is preparing for the commercialization of Weishiping and aims to expedite its availability to domestic patients while pushing for inclusion in the national medical insurance catalog [1] - This approval is a key component of the company's 2030 development strategy, which emphasizes a dual approach of "BD cooperation + self-research" to achieve both commercialization and R&D value [1] - The company plans to exceed 10 billion RMB in revenue by 2028 and over 15 billion RMB by 2030, with a projected annual compound growth rate of over 50% from 2025 to 2030 [1]
云顶新耀：治疗成人患者中重度溃疡性结肠炎新药维适平 获中国上市批准