Core Viewpoint - NEFECON (Budesonide Delayed-Release Capsules) has been included in the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" in China, marking it as the only IgA nephropathy treatment recommended by both domestic and international guidelines, solidifying its position as a cornerstone therapy for IgA nephropathy patients [1][3]. Group 1: Treatment Guidelines - The guidelines recommend initiating treatment for patients with proteinuria ≥0.5 g/d and suggest kidney biopsy, with treatment goals aimed at reducing proteinuria to <0.5 g/d and maintaining an estimated glomerular filtration rate (eGFR) decline of <1 ml/min annually [2]. - New monitoring for hematuria has been introduced, and interventions targeting immune damage, including reducing pathogenic IgA, are emphasized [2]. - The guidelines advocate for early, cause-targeted, and comprehensive treatment strategies for IgA nephropathy patients, with NEFECON as the preferred treatment option [2][3]. Group 2: Clinical Significance - The inclusion of NEFECON in the guidelines is seen as a significant advancement for clinical practice in China, providing a scientifically backed treatment option for IgA nephropathy patients [3]. - NEFECON is the first and only IgA nephropathy treatment fully approved in China, the US, and Europe, demonstrating significant clinical advantages such as delaying eGFR decline and reducing proteinuria [3][5]. - The NefIgArd Phase III clinical trial showed that NEFECON significantly reduced the risk of kidney function decline by 50% compared to placebo, with a 66% reduction in the Chinese population, potentially delaying the need for dialysis or kidney transplant by 12.8 years [5].

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].