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荣昌生物涨超7% 泰它西普拟纳入优先审评品种 治疗lgA肾病III期研究达成A阶段主要
Zhi Tong Cai Jing·2025-09-29 03:24

Core Viewpoint - Rongchang Biopharma (09995) saw a stock increase of over 7%, reaching 109.4 HKD with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy, significantly reducing proteinuria levels [1][1][1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE announced that Taitasip is proposed for priority review for treating IgA nephropathy, which poses a risk of progression [1] - On August 27, Rongchang Biopharma reported that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1][1][1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, acting as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1][1][1]