前沿生物FB7013临床试验申请获受理，IgA肾病治疗添中国原研新力量

Core Viewpoint - The clinical trial application for FB7013, a novel siRNA drug targeting the MASP-2 protein for IgA nephropathy treatment, has been accepted by the National Medical Products Administration of China, marking a significant advancement in innovative drug development for this condition [1] Group 1: Drug Mechanism and Innovation - FB7013 is the first-in-class siRNA drug targeting the MASP-2 protein, aiming to block the abnormal activation of the lectin pathway and reduce complement-mediated kidney damage, providing a new targeted treatment option for IgA nephropathy [1] - The drug has potential for expansion into other complement-related diseases such as membranous nephropathy and diabetic nephropathy, potentially benefiting a wider patient population [1] Group 2: Preclinical Data and Efficacy - Preclinical studies demonstrate FB7013's strong, long-lasting, and safe effects, with over 95% reduction in serum MASP-2 protein levels after a single injection, maintaining over 90% reduction for 105 days [2] - In IgA nephropathy models, FB7013 shows significant dose-dependent efficacy, with reductions in urinary protein levels and increases in glomerular filtration rate, indicating substantial improvement in kidney pathology [2] - Safety assessments indicate no significant off-target risks and no adverse effects on cardiovascular, respiratory, or central nervous systems in preclinical studies [2] Group 3: International Recognition and Market Potential - FB7013 has gained international academic recognition, with the company presenting its preclinical efficacy data at the 2025 ASN Kidney Week conference in Houston, Texas, showcasing the strength of Chinese innovative drugs [3] - The global IgA nephropathy patient population is projected to grow from 9.3 million in 2020 to 10.2 million by 2030, with the treatment market expected to increase from $567 million in 2020 to $1.196 billion by 2025, reflecting a compound annual growth rate of 16.1% [4] - The acceptance of FB7013's clinical trial application represents a significant breakthrough for the company in the small nucleic acid innovative drug sector, reinforcing its commitment to advancing innovative drug development [4]