Core Viewpoint - The release of the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" marks a significant advancement in the treatment of IgA nephropathy, with the inclusion of NEFECON as a recommended therapy for patients at risk of disease progression [1][2][3] Group 1: Guidelines and Recommendations - The guidelines emphasize the need for etiology-based treatment, early intervention, and comprehensive management strategies for IgA nephropathy patients in China [2] - For patients with proteinuria ≥0.5g/d, kidney biopsy and treatment initiation are recommended, aiming for proteinuria <0.5g/d and an estimated glomerular filtration rate (eGFR) decline of less than 1ml/min per year [2] - The guidelines introduce blood urine monitoring and suggest interventions targeting immune damage, including the use of NEFECON to reduce pathogenic IgA levels [2] Group 2: NEFECON's Clinical Significance - NEFECON is recognized as the only etiology-based treatment for IgA nephropathy, establishing its position as a first-line therapy in global kidney disease guidelines [3][4] - The NefIgArd study demonstrated that NEFECON significantly reduces the risk of kidney function decline, with a 50% reduction in eGFR decline compared to placebo, and up to 66% in the Chinese population [4] - NEFECON's approval by the National Medical Products Administration (NMPA) and its inclusion in the national medical insurance drug list further solidify its role in treating IgA nephropathy [4][5]

Core Viewpoint - Yunding Xinyao's drug, Naisukan® (Budesonide Enteric Capsules), has received full approval from the National Medical Products Administration (NMPA) for treating adult patients with Immunoglobulin A Nephropathy (IgAN) at risk of disease progression, marking it as the first and only drug in China for this indication [1][2] Group 1: Drug Approval and Clinical Impact - The full approval of Naisukan® is based on complete data from a Phase III clinical trial, demonstrating significant renal function protection and removing restrictions on proteinuria levels, thus broadening the patient base [2][4] - The drug is expected to delay the progression of IgAN to end-stage renal disease by an estimated 12.8 years, significantly reducing the burden on patients, families, and the healthcare system [2][4] Group 2: Market Penetration and Accessibility - Naisukan® has been included in the national medical insurance drug list, enhancing affordability and accessibility for IgAN patients, with implementation starting from January 1, 2025 [3] - As of March 2024, the drug has reached over 600-700 core hospitals across 26 provinces, covering more than 60% of the target patient population [3] Group 3: Future Growth Potential - The combination of increasing clinical demand, gradual insurance coverage, and recommendations from authoritative guidelines is expected to drive market penetration and sales growth for Naisukan® [4] - The drug is projected to achieve peak annual sales exceeding 5 billion by 2030, solidifying Yunding Xinyao's market leadership in IgAN treatment and providing sustainable long-term returns [4]