国家药监局：完全批准耐赋康用于治疗具有疾病进展风险的原发性IgA肾病成人患者

Core Viewpoint - Yunding Xinyao's drug, Naisfukang® (Budesonide enteric-coated capsules), has received full approval from the National Medical Products Administration (NMPA) for treating adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, marking it as the only drug in China approved for this indication [2][4]. Group 1: Drug Approval and Impact - Naisfukang® has transitioned from conditional approval to full approval, allowing it to be used for all IgAN patients at risk of progression, thus broadening its patient base and addressing unmet clinical needs [2][3]. - The drug's approval is based on complete clinical data from the NefIgArd Phase III study, which demonstrated significant renal function protection over two years [4]. Group 2: Clinical Significance and Guidelines - IgA nephropathy is the most common primary glomerulonephritis and a leading cause of renal failure, with Asian populations having a 56% higher risk of progression to end-stage renal disease (ESRD) [3][4]. - The 2024 KDIGO guidelines highlight Naisfukang® as the only treatment proven to reduce IgA and IgA immune complex levels, emphasizing its role in changing treatment standards for IgAN [4]. Group 3: Accessibility and Insurance Coverage - Naisfukang® has been included in the national medical insurance drug list, effective January 1, 2025, enhancing affordability and accessibility for IgAN patients across 26 provinces and cities in China [4].