Core Insights - Novo Nordisk has submitted applications to the FDA for the approval of icodec insulin for the treatment of type 2 diabetes and Mim8 for the treatment of hemophilia A [1] Group 1: Icodec Insulin - Icodec insulin is a long-acting insulin formulation designed based on oral insulin OI338, with a half-life of 196 hours [2] - The design modifications include replacing an 18C fatty acid with a 20C fatty acid to enhance binding affinity to human serum albumin, and substituting Tyr with His at position 16 of the B chain to reduce affinity to human insulin receptors [2] - The initial BLA submission in April 2023 included indications for both type 1 and type 2 diabetes, but the FDA advisory committee found insufficient data for type 1 diabetes, leading to a narrowed indication for type 2 diabetes in the resubmission [2] Group 2: Mim8 - Mim8 is a bispecific antibody developed using Genmab's DuoBody technology, designed to mimic the action of coagulation factor VIIIa (FVIIIa) and bridge factors IXa (FIXa) and X (FX) [3] - It exhibits approximately 15 times the coagulation activity compared to emicizumab [3] - Hemophilia A, affecting around 80%-85% of the estimated 1.125 million hemophilia patients globally, is caused by a deficiency or defect in FVIII [3] Group 3: Hemophilia Treatment Landscape - There are currently 46 approved hemophilia drugs globally, with only 8 being non-factor therapies [4] - Among these, several drugs have been approved specifically for hemophilia A patients, including concizumab, valoctocogene roxaparvovec, emicizumab, marstacimab, and fitusiran [4]