Core Viewpoint - Yunding Xinyao announced the approval of its new drug, Weishiping® (Arginine Acquimod Tablets), in China for treating 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 Asian multicenter Phase III registration clinical trial ENLIGHTUC 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 will actively prepare for the commercialization of Weishiping® and aims to expedite its availability to domestic patients while promoting its 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