前沿生物：2025年末公司已就FB7013向国家药监局提交IND申请并获受理，FB7013正式进入临床申请审批通道

Core Viewpoint - Frontline Bio's FB7013 is the world's first clinical candidate targeting the key protein MASP-2 via siRNA, showing significant potential as a First-in-Class drug [1] Group 1: Drug Efficacy and Safety - Preclinical data indicates that a single subcutaneous injection in healthy crab-eating macaques resulted in over 95% reduction of serum MASP-2 protein, with effects lasting over 105 days [1] - In an IgA nephropathy model in crab-eating macaques, FB7013 demonstrated a dose-dependent improvement in key metrics such as urine total protein to creatinine ratio (uPCR), urine total protein (uTP), and estimated glomerular filtration rate (eGFR) [1] - After 8 weeks of high-dose treatment, there was a 43% reduction in glomerular IgA deposits and a 36% decrease in mesangial cell numbers, with off-target analysis showing no significant off-target risks, indicating good safety [1] Group 2: Clinical Development and Regulatory Status - As of the end of 2025, the company has submitted an IND application for FB7013 to the National Medical Products Administration, which has been accepted, marking the drug's entry into the clinical application approval process [1] Group 3: Business Development and Collaboration - The company maintains an open attitude towards business development collaborations and actively explores opportunities that align with its product development strategy [1]