Frontier Biotechnologies (688221) announced that on December 22, 2025, the company submitted an Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) for FB7013. Developed in-house, FB7013 is a targeted siRNA drug designed to inhibit MASP-2, a key protein in the lectin pathway of the complement system. On December 31, 2025, the company received the official notice confirming that the application has been formally accepted.
FB7013 injection is intended for the treatment of primary immunoglobulin A nephropathy (IgAN) and possesses first-in-class potential. According to preclinical data, FB7013 demonstrated potent and long-lasting inhibition of the target protein in healthy cynomolgus monkeys, achieving a maximum knockdown rate of over 95%. In IgAN models, FB7013 showed significant efficacy, with dose-dependent improvements in both total urinary protein and glomerular filtration rate (GFR), alongside a favorable safety profile.
In the first three quarters of 2025, Frontier Biotechnologies reported a revenue of 103 million RMB and a net loss attributable to the parent company of 160 million RMB.
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