Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taizhisip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Company Developments - On September 28, the CDE announced that Rongchang Biologics' Taizhisip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics reported that the Phase III study of Taizhisip for treating 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] Drug Mechanism - Taizhisip 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, serving as key drivers of the disease [1] - By inhibiting these two factors, Taizhisip can reduce B cell proliferation, lower plasma cell counts, and decrease abnormal immunoglobulin production, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1]
港股异动 | 荣昌生物(09995)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阶段主要终点