Core Viewpoint - The company has submitted a clinical trial application for its self-developed siRNA drug FB7013, targeting the MASP-2 protein, for the treatment of primary IgA nephropathy, marking it as the first-in-class drug in this category [1][2]. Drug Registration Clinical Trial Application - Product Name: FB7013 Injection - Application Matter: Domestic production drug registration clinical trial - Indication: Intended for the treatment of primary IgA nephropathy - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Drug Mechanism - FB7013 is the first siRNA drug globally to target the MASP-2 protein, with potential for first-in-class status. It aims to inhibit MASP-2 activity to block the abnormal activation of the lectin pathway, thereby reducing complement-mediated kidney tissue damage. Future applications may extend to diseases related to complement activation, such as membranous nephropathy and diabetic nephropathy [2]. Preclinical Research Data - In healthy crab-eating macaques, FB7013 demonstrated strong and lasting inhibition of the target protein, achieving over 95% knockdown of serum MASP-2 protein after a single subcutaneous injection, with over 90% knockdown maintained for 105 days. This suggests potential for administration every 3-6 months in clinical settings, enhancing patient compliance. In IgA nephropathy models, FB7013 showed significant efficacy and good safety profile, with dose-dependent reductions in urinary protein levels and increases in glomerular filtration rate. High-dose treatment for 8 weeks resulted in a 36% reduction in mesangial cell numbers and a 43% reduction in IgA deposition. No significant off-target risks were identified [3]. Potential Market Outlook - IgA nephropathy is one of the most common primary glomerular diseases globally, characterized by abnormal deposition of IgA immune complexes in the glomeruli, leading to chronic kidney failure. According to Frost & Sullivan, the number of IgA nephropathy patients increased from 8.8 million in 2015 to 9.3 million in 2020, and is expected to reach 10.2 million by 2030. The global market for IgA nephropathy treatment drugs is projected to grow from $567 million in 2020 to $1.196 billion by 2025, with a compound annual growth rate of 16.1%, indicating significant market potential [5].
前沿生物药业（南京）股份有限公司关于FB7013境内生产 药品注册临床试验申请获得受理通知书的自愿性披露公告