On October 26, Eli Lilly announced that it had submitted a new drug listing application for tirzepatide to the US FDA and the European Union EMA, and attached a priority review voucher when submitting the NDA data to the FDA to expedite the listing of tirzepatide.

Tirzepatide is a new type of GLP-1R/GIPR dual agonist administered subcutaneously once a week, which integrates the effects of two incretins into one molecule. GLP-1 (glucagon-like peptide 1) is a kind of "glucagon" naturally secreted by the mucosa of the human gastrointestinal tract, which can bind to receptors on pancreatic islet cells and stimulate insulin secretion, thereby reducing blood sugar. , And can reduce food intake and delay gastric emptying, which is conducive to weight control. GIP (glucose-dependent insulin-promoting polypeptide) is a hormone that may supplement the effects of GLP-1 receptor agonists. Pre-clinical studies have shown that GIP can reduce weight by reducing food intake and increasing energy consumption. Combined with GLP-1 receptor agonists, it may have a greater impact on patients' blood sugar and weight.

The importance of Tirzepatide to Eli Lilly is self-evident, because this is another trump card of Eli Lilly in the diabetes drug market after dulaglycotide. In the large-scale phase III clinical trials, starting from the ambitious project code named "SURPASS", Eli Lilly has shown its determination to confront its rival's heavyweight smeglutide, not only the design of the phase III trials Similar to the SUSTAIN project of smeglutide, it also includes a phase III trial of "head-to-head" PK directly with smeglutide, and finally proved that Tirzepatide has better blood sugar and weight reduction effects than smeglutide. Peptide.

For Eli Lilly, speeding up the listing of Tirzepatide is also an inevitable choice for Eli Lilly to consolidate its leading position in the hypoglycemic drug market. On the one hand, Trulicity (dulaglycotide) has gradually reduced its market share advantage compared to Ozempic (simeglutide), and simeglutide has a series of oral dosage forms, weight loss, Alzheimer’s disease, NASH, etc. Innovative and breakthrough gameplay improves clinical influence and affects the choice of medications for patients and doctors. Trulicity alone obviously cannot maintain the lead.

On the other hand, Novo Nordisk is also simultaneously developing GLP-1R/GIPR dual agonists and a combination therapy of smeglutide + GIPR. Eli Lilly’s rapid introduction of Tirzepatide to the market also hopes to establish more in this new direction. A solid lead.

According to Eli Lilly's CEO David Ricks in the Q3 financial report disclosure information, Tirzepatide is the best treatment option in the field of diabetes. It can be seen that Eli Lilly has high hopes for this product, and even uses a valuable priority review coupon to get the opportunity to accelerate the listing 4 months in advance. According to the FDA's priority review procedures and timetable, Eli Lilly expects that it will take about 8 months from the submission of the application to the approval of the market, that is, the approval of tirzepatide will be ushered in at the end of June next year.

The cardiovascular outcome of Tirzepatide is expected to be announced in 2024, and clinical trials for obesity, NASH, and HFpEF are also underway. In addition, Eli Lilly is also developing oral GLP-1R agonist LY3502970 (Phase II), GIPR/GLP-1R/GCGR triple agonist LY3437943 (Phase II).