Core Insights - The approval of the expanded production application for the drug Neficon (Budesonide Enteric-Coated Capsules) marks a significant milestone as it is the first and only fully approved treatment for IgA nephropathy in China, the US, and Europe [1][2] - The drug is positioned as a cornerstone therapy for IgA nephropathy, addressing the growing clinical demand in China and Asia, where the disease prevalence is notably high [1] - The drug's unique mechanism of action and clinical advantages have led to its inclusion in both international and domestic clinical guidelines, solidifying its status as a first-line treatment [2] Company Developments - The National Medical Products Administration (NMPA) approved Neficon in November 2023 for adult patients with progressive primary IgA nephropathy, filling a treatment gap in China [2] - Neficon was included in the national medical insurance drug list in November 2024, and received full approval in May 2025, removing restrictions on proteinuria levels for most patients [2] - The CEO of the company emphasized the importance of increasing production capacity to meet the rising clinical treatment needs of IgA nephropathy patients in Asia [1] Industry Context - IgA nephropathy has a high incidence in Asia, with China having one of the highest rates of primary glomerular diseases, estimated to have over 5 million patients and more than 100,000 new cases annually [1] - The drug Neficon has demonstrated significant clinical efficacy, reducing the risk of kidney function decline by 50% in global studies, and by 66% in the Chinese population, delaying disease progression to dialysis or kidney transplantation by an average of 12.8 years [1]
云顶新耀(01952)全球首个IgA肾病对因治疗药物耐赋康®扩产获批，扩大患者用药可及