T Medicine has been approved in the United States. Will the "Global Medicine King" be coming soon? The only obstacle is production capacity!
Industry analysts predict that Teserbopeptide could become one of the best-selling drugs in history, with annual sales exceeding $50 billion, surpassing Novo Nordisk's semaglutide drugs Ozempic and Wegovy.
On Wednesday, Eastern Time, Eli Lilly announced that its drug Zepbound has been approved by the US Food and Drug Administration (FDA) for long-term weight management in adults and is expected to be launched in the US market by the end of this year.
After the news was announced, Eli Lilly's stock price continued to rise, reaching nearly $626 at the close, a daily increase of over 4%, and ultimately closing up 3.2%, hitting a new all-time high.
Zepbound contains an active ingredient called tirzepatide, which is known domestically as "替尔泊肽". Relevant studies have shown that tirzepatide can produce better weight loss effects than semaglutide, which is known as the "magic weight loss drug".
Industry analysts predict that tirzepatide may become one of the best-selling drugs in history, with annual sales exceeding $50 billion, surpassing Novo Nordisk's semaglutide drugs Ozempic and Wegovy. Novo Nordisk's report shows that by 2022, the total sales of Ozempic and Wegovy will be nearly $10 billion.
The FDA approval of Zepbound this time helps Eli Lilly establish a position on par with Novo Nordisk, but whether it can surpass Novo Nordisk still depends on a key issue - production capacity and supply.
Is tirzepatide the real "king of drugs"?
In fact, Eli Lilly's innovative drug Mounjaro, which was approved for the treatment of type 2 diabetes in May last year, is also a tirzepatide drug. According to previous reports, due to the supply restrictions of Wegovy, some Americans have used Mounjaro for weight loss.
Tirzepatide is a dual receptor agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). It integrates the effects of both intestinal insulin promoters into one molecule and is injected once a week.
GIP can supplement the action of GLP-1 receptor agonists. In preclinical models, it has been shown that GIP can reduce food intake and increase energy expenditure, thereby reducing weight. When combined with GLP-1 receptor agonists, it may have a greater impact on glucose levels and weight.
Relevant trials have shown that tirzepatide has better weight loss effects than semaglutide.
According to the early research results announced by Eli Lilly in late April, Mounjaro helped overweight or obese diabetic patients lose 16% of their body weight, which is more than 34 pounds, in nearly 17 months. Users of semaglutide lost about 15% of their body weight in 16 months. Further research has proven the weight loss effect of semaglutide: non-diabetic patients who injected the drug weekly experienced a 22% reduction in weight. For typical patients taking the highest dose, this means losing over 50 pounds.
Dr. Nadia Ahmad, the Medical Director of Obesity Clinical Development at Novo Nordisk, said that weight loss becomes extremely difficult for individuals with diabetes, making the later-stage research particularly important. She stated, "We have never seen this level of weight loss before."
The final showdown: Production capacity!
With the FDA approval of Zepbound, Novo Nordisk has established a position on par with Eli Lilly, but whether they can surpass Eli Lilly ultimately depends on resolving the critical issues of production capacity and supply.
Due to the enormous demand for weight loss drugs, all three drugs - Wegovy, Ozempic, and Mounjaro - have appeared on the FDA's drug shortage list at different doses.
An article by Wall Street CN titled "FDA Warning: Severe Shortage of Weight Loss Miracle Drug" also mentioned that there has been a global shortage of semaglutide for nearly a year, and the shortage is expected to continue.
Novo Nordisk has limited the supply of lower doses of Wegovy to ensure that those already using the drug can continue to have access, but meeting the demand of existing patients is expected to take several years.
Both Eli Lilly and Novo Nordisk are investing billions of dollars to expand the production capacity of their weight loss drugs.
Eli Lilly is constructing two factories in North Carolina, with an investment of $4 billion, aiming to double the production of GLP-1 receptor agonists containing semaglutide by the end of 2023.
One of the factories is located in the Research Triangle Park in Durham and has already begun production. The factory utilizes high-speed automation, autonomous vehicles, and robotic arms to produce autoinjectors for Mounjaro. The factory is also preparing for product formulation, mixing the active ingredient semaglutide with other components to create finished drugs, which are then injected into the autoinjectors.
Eli Lilly stated that the factory operates continuously, 24 hours a day, 7 days a week, to meet the demand. However, according to Edgardo Hernandez, President of Manufacturing Operations at Eli Lilly, synthesizing semaglutide takes several months as it involves a series of chemical reactions to connect amino acids into peptide chains, as well as purification and quality control.
"We are working towards achieving large-scale production," he said. "We are actively expanding our production capacity."
Lars Fruergaard Jorgensen, CEO of Novo Nordisk, stated in an interview with the media in August, "Due to the shortage, some people may think that we are not producing any products, but we have one of the most popular products in this category, and we are growing by double-digit percentages." "So we are significantly increasing our capacity, and we will be making substantial investments in the coming years." These investments are expected to generate multiple returns. According to BMO Capital Markets, a leading investment firm, it is estimated that by 2035, obesity drugs will generate annual revenues of $100 billion globally.