Sugar reduction and re-star Tirzepatide reported production in China, and sales are expected to exceed 10 billion US dollars in 2030

On September 7, Eli Lilly's application for the import of "Tilpopeptide Injection" Category 5.

According to the CDE drug clinical trial registration and information publicity platform, Tirzepatide has registered a total of 7 clinical trials in China, with indications related to type 2 diabetes, overweight/obesity, obstructive sleep apnea and ejection fraction reserved heart failure of

In the treatment of type 2 diabetes, in January this year, Eli Lilly announced that Tirzepatide had reached the primary and all key secondary endpoints in a 40-week SURPASS-AP clinical trial (comparing Tirzepatide with dose-titrated insulin glargine), significantly reducing glycosylated hemoglobin and body weight
in patients with type 2 diabetes.

SURPASS-AP is an international multicenter Phase III clinical trial designed to compare the efficacy and safety
of treatment with three different doses of Tirzepatide (5 mg, 10 mg and 15 mg) and dose titration of insulin glargine in patients with type 2 diabetes whose blood glucose is still poorly controlled after receiving stable doses of metformin (with or without sulfonylureas).

The results of the trial showed that compared with the control group of insulin glargine (the average dose was 25.
4 per day at 40 weeks), different doses of Tirzepatide (5 mg, 10 mg and 15 mg) achieved significant reductions in glycosylated hemoglobin and body weight, and up to 86% of patients in the three dose groups achieved less than 7% of glycosylated hemoglobin (the control target recommended by the Diabetes Branch of the Chinese Medical Association).

Image source: Eli Lilly official website

In terms of safety, Tirzepatide's overall safety is similar to that of previously reported SURPASS series trials, in which mild to moderate gastrointestinal reactions are the most common adverse reactions and decrease
with continued administration.
Moreover, the incidence of hypoglycemia below 3.
9 mmol/L (70 mg/dL) in the Tirzepatide three dose groups was significantly lower than in the insulin glargine group
.

The RESULTS of the SURPASS-AP trial are used to support Tirzepatide's application for type 2 diabetes indications in China and other Asia-Pacific regions, and it is expected that in the future, Tirzepatide can be approved for listing in China as soon as possible, benefiting the majority of type 2 diabetes patients
.

In addition, Tirzepatide's strength in weight loss should not be underestimated
.
In April, Eli Lilly announced positive results
in Tirzepatide's global Phase III clinical trial for the treatment of obese or overweight populations, SURMOUNT-1 。 The trial was the first global multicenter, randomized, double-blind, parallel, placebo-controlled trial conducted by Tirzepatide in obese patients, enrolling a total of 2539 obese or overweight patients with at least one disease (hypertension, dyslipidemia, obstructive sleep apnea syndrome or cardiovascular disease, but not diabetes mellitus), and subjects were grouped 1:1:1:1 to receive 5 mg, 10 mg, 15 mg Tirzepatide or placebo.
To assess the difference
in weight loss efficacy and safety between the addition of Tirzepatide and placebo on the basis of a low-calorie diet and enhanced exercise.

The results showed that the weight loss effect at week 72 was significantly better in the Tirzepatide (5 mg, 10 mg, 15 mg) treatment group than in the placebo control group, while the subgroup receiving the highest dose (15 mg) tirzepatide had an average weight loss of 22.
5% (about 24 kg), of which 63% of the subjects lost weight by at least 20%.

It is worth mentioning that Tirzepatide is the first drug
in the Phase 3 clinical trial to reduce weight by an average of more than 20%.

Obesity, like diabetes, has a very large
patient volume.
If the diabetes market is too crowded, the obesity market is expected to be a big boost
for Tirzepatide to reach the top.
It is reported that there are limited similar mechanism drugs that have been approved in the obesity market, and the only approved GLP-1 receptor agonists are Novo Nordisk's liraglutide and smegluotide
.
Among them, liraglutide was approved by the FDA in December 2014 under the trade name Saxenda, and its phase III clinical results showed that 60% of obese patients lost 5% of their body weight after injecting liraglutide, and 1/3 of the patients' weight loss could reach 10%.

Smeglutide was approved by the FDA in August 2021 under the trade name Wegovy, and data from 4 clinical trials in phase IIIa showed that 2.
5 mg of smeglutide was injected subcutaneously once a week, with weight loss of 16.
9%-18.
2%.

Industry insiders said that most of the weight loss effects of diet pills listed in the past hovered in the range of 5%-10%, and the side effects were large and the continuity was poor, if they could lose more than 15% of weight, it would be very promising
.
Judging from the published trial data, Tirzepatide and smegrogotide will stage a fairy fight
in the weight reduction market.
At present, Novo Nordisk has led the two products of Saxenda and Wegovy to the first to enter the game, and has achieved good results
.
It is reported that the sales of these two products in 2021 will reach DKK 8.
4 billion, while the sales of these two products in the first half of this year will reach DKK 7.
045 billion, of which Saxenda 2022H1 sales of DKK 2.
585 billion and Wegovy 2022H1 sales of DKK 4.
46 billion
.
Wegovy's crushing performance after the listing was truly stunning
.

In addition to efficacy, pricing is also an important factor
influencing patient choice.
Tirzepatide (Mounjaro) is currently priced at about $974 per month (4 sticks) in the U.
S.
, while Wegovy is priced at $1349 per month and Saxenda is priced at about $
1,000 per month.
While Mounjaro has yet to be approved for weight reduction, Wells Fargo analyst Mohit Bansal says its lower pricing could open the door
to off-label use.

In addition, Tirzepatide is also expected to be a potential therapy
for diseases such as heart failure (HFpEF) and non-alcoholic steatohepatitis (NASH) with preserved ejection fractions.
Evaluat Vantage had predicted that its sales in 2026 were expected to reach $4.
9 billion, although industry analysts believe that the potential of Tirzepatide is generally underestimated, and Silicon Valley Bank (SVB) believes that its sales may reach $
14.
1 billion in 2030.

However, there is no eternal king in the new drug research and development arena, and there are still many after-waves in the type 2 diabetes and weight loss markets, such as Innovent Bio's GLP-1/GCGR dual-target agonist Mazdutide (IBI362), SCOHIA PHARMA/Huadong Pharmaceutical's GLP-1R/GIPR dual-target agonist SCO-094, Boehringer Ingelheim's GLP-1/GCGR dual-target agonist BI456906, Amgen's GLP-1R/GIPR dual-target agonist AMG133
.

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