GLP-1 drugs have gained significant players in the field of weight loss, with prices 20% cheaper than Nuo and Nordsmiglutide.
On November 8 local time, Eli Lilly, a multinational pharmaceutical giant, announced that Tirzepatide was approved by the U.S. Food and Drug Administration (FDA) for chronic weight management, which is applicable to adult patients with obesity (BMI ≥ 30kg/m2) or overweight (BMI ≥ 27kg/m2), and such patients are accompanied by weight related complications, such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease. When using this medication, patients also need to combine it with controlling their diet and increasing physical activity.
The above Tirzepatide is a GLP-1/GIP dual agonist that is injected once a week. It was approved by FDA for the first time in May 2022 for the treatment of type 2 diabetes, and its trade name is Mounjaro. The newly approved weight loss certificate product name is Zepbound. Lilly mentioned that the US market is expected to have six doses of Zepbound by the end of this year, namely 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg, priced at $1059.87.
Lilly stated in its official press release that the above price is about 20% lower than the 2.4mg injection of Smegglutide, which is also used for weight loss. The company is implementing a commercial savings card program to make it easier for people who may benefit from Zepbound to use it. Specifically, this plan includes that individuals with Zepbound commercial insurance may be eligible to pay as little as $25 for a prescription for one or three months; Individuals who have commercial insurance but have not covered Zepbound may be eligible to pay as low as $550 for a 1-month Zepbound prescription, which is approximately 50% lower than the listed price.
Previously, with diabetes indications, Tirzepatide contributed $483 million in revenue to Lilly in 2022. The latest quarterly report shows that Tirzepatide's total sales revenue for the first three quarters was $2.96 billion, of which the first quarter sales were $570 million, the second quarter sales were $980 million, and the third quarter sales revenue was $1.41 billion. Now that the weight loss certificate has been approved, it is foreseeable that Lilly's performance will further benefit.
This FDA approval is mainly based on positive data from SURBOUNT-1 and SURBOUNT-2 studies. Data from the 72 week clinical trial showed that adults using Zepbound lost an average of 48 pounds at the highest dose. According to public sources, Lilly is also promoting other research on Tirzepatide. On October 18th, Lilly China announced that the detailed results of the SURMOUNT-3 clinical study were recently published simultaneously in Nature Medicine and ObesityWeek 2023. In the SURMOUNT-3 study, after 12 weeks of intensive lifestyle intervention, the average weight loss of subjects after receiving Tirzepatide treatment was 21.1%, and the total average weight loss of subjects during the 84 week trial period was 26.6%.
When will the Tirzepatide officially approved in the United States be approved in China? At present, Tirzepatide has not been approved with any indication in China, and the listing application of diabetes indication was accepted by the drug regulatory department in September 2022. In August of this year, Lilly China also announced that the registration application for Tirzepatide to improve long-term weight management in overweight patients with adult obesity or at least one weight related comorbidities based on a low calorie diet and increased exercise has been officially accepted.
On October 3, Eli Lilly announced the latest research data on Tirzepatide at the 59th annual meeting of the European Association for diabetes Research (EASD). The research results showed that Tirzepatide (10 mg, 15 mg) achieved a common primary endpoint and all key secondary endpoints, achieving significant and clinically significant weight loss in adult obese and overweight patients in China.
At the 6th China International Import Expo, Lilly also displayed information on Tirzepatide at the booth, stating that the drug is the first and only FDA approved GIP/GLP-1 receptor agonist. Novo Nordisk, also known as the GLP-1 Track Star Company, is a single target drug for GLP-1.
It is worth mentioning that in China, Lilly is also collaborating with Xinda Biotechnology to promote the use of IBI362, a GLP-1/GCGR dual agonist. According to the news released by Xinda Biotechnology on October 30th, the Phase II clinical study of high-dose 9mg of Marsdol peptide in Chinese obese subjects completed a 48 week treatment period after reaching the main research endpoint of 24 weeks. The weight loss effect was significant, the safety was excellent, and multiple metabolic benefits were demonstrated, indicating that it is expected to become a potential better alternative surgical option for long-term weight management in moderate to severe obesity populations in China. Xinda Biotech plans to launch a phase III clinical study of 9 mg of Marsdolide in obese Chinese subjects by the end of 2023.
Since the beginning of this year, with the positive progress in weight loss and Alzheimer's disease, Lilly's stock price has surged all the way, becoming the world's highest pharmaceutical company by market value. Affected by the approval of weight loss drugs, as of the close of the US stock market on November 8th, Lilly closed up 3.26% at $619.5 per share, with a market value of $588.1 billion.
It is worth noting that, like Novo Nordisk Smeglutide, which has been warned of risks such as thyroid cancer by EU regulatory agencies, the US approval of Zepbound also mentions its adverse reactions. Adverse reactions include nausea, diarrhea, vomiting, constipation, indigestion, hair loss, gastroesophageal reflux, etc. Lilly stated that in the study, most nausea, diarrhea, and vomiting occurred when people increased their dosage, but the effect usually weakened over time.
In addition, Zepbound's label also contains a black box warning about thyroid C-cell tumors. Patients with a personal or family history of medullary thyroid cancer. At the same time, the label also includes warnings about pancreatitis, gallbladder problems, hypoglycemia (hypoglycemia), acute kidney injury, diabetes retinopathy, and depression or suicidal thoughts in patients with type 2 diabetes.