From September 17 to 20, 2025, the 18th International IgA Nephropathy Symposium (IIgANN 2025) was held in Prague, Czech Republic. At the conference, Frontier Biotech presented, for the first time as an oral report, the preclinical data for FB7011, a self-developed dual-target small nucleic acid drug with global first-in-class (FIC) potential. This drug simultaneously targets MASP-2, a key protein in the complement system's lectin pathway, and CFB, a key protein in the alternative pathway, blocking the pathogenesis of IgA nephropathy by precisely intervening in the abnormal activation of the complement system.

Data presented at the conference showed that a single subcutaneous dose of FB7011 (6 mg/kg) in cynomolgus monkeys potently and persistently inhibited the expression of both MASP-2 and CFB target proteins simultaneously. The maximum inhibition efficiency for both targets exceeded 95%, and the inhibitory effect lasted for over 12 weeks, suggesting that dosing intervals of every 4-6 months may be possible in humans. In a cynomolgus monkey model of IgA nephropathy, a single subcutaneous dose of FB7011 significantly improved indicators related to disease progression (uTP, uPCR, and eGFR), demonstrating therapeutic effects. Furthermore, FB7011 exhibited a low off-target risk and immunotoxicity, showing a good safety profile in in vivo animal studies. The presentation on FB7011 received significant attention from clinical experts and researchers at the conference. Its novel mechanism of action holds the promise of providing a new, effective, and safe treatment option for IgAN patients while greatly improving medication compliance.

Another drug with first-in-class potential, FB7013, a single-target small nucleic acid drug targeting MASP-2, also demonstrated excellent preclinical data. In healthy monkeys, a single subcutaneous dose of FB7013 resulted in sustained reduction of the target protein for 16 weeks, suggesting a potential clinical dosing schedule of one injection every 4-6 months. In the cynomolgus monkey IgA nephropathy model, treatment for 8 weeks effectively inhibited disease progression. Not only were core indicators like uPCR significantly improved, but renal pathological damage was also markedly reduced, demonstrating therapeutic potential.

Both FB7011 and FB7013 possess novel mechanisms of action. No small nucleic acid drug with a similar mechanism has been approved or entered clinical trials globally, giving them significant differentiated advantages. They are expected to improve the treatment outcomes for IgA nephropathy and can also be used in combination therapies with drugs of different mechanisms to cover a broader patient population.

IgA nephropathy is the most common primary glomerulonephritis worldwide, characterized by a large patient base and a high risk of disease progression. Statistics indicate that the global number of patients will exceed 10.2 million by 2030. In China, there are approximately 4.59 million adult patients, with over 100,000 new cases annually, of which 80% are young and middle-aged adults aged 20-59. More critically, over half of the patients may progress to end-stage renal disease (ESRD) within 20 years of diagnosis, requiring dialysis or kidney transplantation to sustain life. The cost of dialysis is 120,000-200,000 RMB in the first year and 90,000-160,000 RMB annually thereafter. The annual medical insurance expenditure for dialysis patients in China reaches as high as 38.6-39.4 billion RMB, placing a heavy burden on patients' families and the healthcare system.

Currently, treatment options for IgA nephropathy are limited, and there is an urgent need for safe, effective, and convenient etiological treatments, with vast market potential waiting to be tapped. Frontier Biotech will accelerate the clinical development pace of its pipeline products, striving to create the world's first dual-target small nucleic acid drug for the treatment of IgA nephropathy, offering a breakthrough therapeutic solution for this "silent epidemic."