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]
商业化全面提速 云顶新耀（01952）耐赋康®在中国完全获批