
On March 13, the CDE website showed that the clinical application of Eli Lilly's Class 1 new drug LY3549492 tablets was accepted by the CDE. This is the first time that the drug has been submitted for clinical trials in China.LY3549492 is a glucagon-like peptide-1 receptor(GLP-1R)Non-peptide Agonists(NPA), and a double-blind Phase II clinical trial is currently being conducted overseas.(NCT06683508), to compare the effects of using LY3549492 once daily versus placebo onObese or Overweight Adult SubjectsThe effect of weight management.
Source: CDE Official WebsiteOralGLP-1 Is the new high ground of competition in the current weight-loss drug field. Although Novo Nordisk's oral version of semaglutide was approved for marketing long ago, it still belongs to peptide drugs, and its bioavailability still has room for improvement. In addition, cost and production capacity are also drawbacks of traditional peptide drugs.Compared with traditional peptide GLP-1R agonists,GLP-1R Non-Peptide Small Molecule Agonists Have Many Advantages,Including: Can be administered orally, improving patient compliance; higher bioavailability; high chemical stability, more stable during storage and transportation, not easy to degrade; low production cost, easier to achieve large-scale production, etc. Therefore, oral small molecule GLP1 has become a current research and development hotspot.Eli Lilly has long been established in this field. In addition to LY3549492,Orforglipron developed by Eli Lilly(LY3502970)Also a non-peptide oral GLP-1R small molecule agonist, this drug can be regarded as the pioneer of small molecule GLP-1R drugs. Orforglipron was initially developed by Chugai Pharmaceutical Co., Ltd., a Japanese company, and in 2018, Eli Lilly and Company acquired its global development and commercialization rights with an upfront payment of 50 million US dollars.Currently, Orforglipron is undergoing Phase III clinical trials for the treatment of obesity, type 2 diabetes, and obstructive sleep apnea.It is the GLP-1R small molecule agonist with the fastest research progress.。In China, Hengrui(HRS-7535), Wentai Pharmaceuticals/Jixing Pharmaceuticals(VCT220)Small molecules of GLP-1R have also entered Phase III.Global Small Molecule GLP-1 Research Landscape

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