口服胰岛素上市申请未能成功

Core Viewpoint - The article discusses the unsuccessful application for market approval of the oral insulin capsule by Hefei Tianhui Biotechnology Co., Ltd., which is significant as it is the first oral insulin product submitted for approval globally [4][6]. Group 1: Product Overview - The oral insulin capsule, known as recombinant human insulin enteric-coated capsule, was first submitted for market approval in China in April 2023, aimed at treating type 2 diabetes patients who do not respond well to oral hypoglycemic agents [4][6]. - This product is an introduced product from the Israeli company Oramed [5]. Group 2: Market and Clinical Context - Insulin has been crucial in diabetes treatment, and early initiation of insulin therapy is vital for managing the condition. However, the subcutaneous injection method has led to hesitance among some patients, delaying the start of insulin therapy and affecting blood sugar control [6]. - The development of oral insulin has faced challenges, with major insulin companies experiencing failures in development. The complexity of insulin as a peptide hormone makes oral absorption difficult due to its large molecular weight and susceptibility to enzymatic degradation [7]. Group 3: Clinical Trial and Approval Challenges - The oral insulin capsule faced controversy during its application in China, as the phase III clinical trials conducted abroad had previously failed. In January 2023, Oramed announced that its phase III trial for the oral insulin capsule did not meet its primary and secondary endpoints [7]. - The failure of the market approval application for the recombinant human insulin enteric-coated capsule may impact Tianhui Biotechnology's future investments and strategies [8].