Gan&Lee Pharmaceuticals (SH: 603087) announced that its wholly-owned subsidiary, Gan&Lee Pharmaceuticals Shandong Co., Ltd., has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its investigational drug, GZC8072 tablets. This approval permits the company to initiate clinical trials for the new indication of type 2 diabetes mellitus.
GZC8072 is a next-generation, biased, ultra-long-acting oral peptide weekly formulation independently developed by Gan&Lee Pharmaceuticals. This molecule leverages the company's NovaPeptide technology platform and SupOraTide oral peptide technology platform. By enhancing molecular activity and extending half-life, it also significantly improves oral bioavailability, thereby potentially supporting a once-weekly oral dosing regimen.
As of the date of this announcement, no GLP-1 oral weekly tablet formulation for type 2 diabetes has been approved for marketing globally.