Breaking News! Lilly's "Slimming Injection" has been approved in China, is Simay's strongest competitor here?

On the 19th, the indication of "long-term weight management" for the star drug Tesofensine Injection was approved by the National Medical Products Administration.

In the first quarter, the total revenue of Tesofensine reached $2.324 billion, accounting for 26% of Eli Lilly's total revenue. Together with Semaglutide's performance of over $6 billion in the first quarter, the GLP-1 receptor agonists represented by these "dual giants" have continued to be popular for several years.

Under the name of "weight loss injections," these "dual giants" have been popular in China for many years. Since Tesofensine was approved in China for lowering blood sugar on May 21 and Semaglutide was approved for weight loss on June 25, the approval of Tesofensine for weight loss indications in China has been highly anticipated.

With the approval of this weight loss indication, the "dual giants" have finally officially entered the weight loss market in China.

Popular Worldwide, with an Average Weight Loss of 26.6%

Tesofensine is currently the first and only approved glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist.

GLP-1 is an incretin that promotes insulin secretion in a glucose-dependent manner, inhibits glucagon secretion to lower blood sugar, and can also delay gastric emptying, thus having weight loss effects. Tesofensine can bind to and activate GIP receptors and GLP-1 receptors to regulate appetite, reduce food intake, lower weight, and decrease fat mass.

The approved weight loss indication this time is for long-term weight management in adults with the following requirements based on controlling diet and increasing exercise: BMI ≥28 kg/m² (obesity), or ≥24 kg/m² (overweight) with at least one weight-related comorbidity (such as hypertension, abnormal blood lipids, high blood sugar, obstructive sleep apnea, cardiovascular disease, etc.).

Tesofensine was first approved by the U.S. Food and Drug Administration (FDA) in May 2022 for improving adults with type 2 diabetes, and subsequently approved in the EU, Japan, and other regions. In November 2023, FDA's approval officially allowed Tesofensine to enter the chronic weight management market On May 21st this year, the National Medical Products Administration approved the use of Tirzepatide for glycemic control in type 2 diabetes patients based on 5 global Phase III studies - the SURPASS series clinical trials, and a Phase III study in the Asia-Pacific region - SURPASS-AP-Combo clinical trial (83.4% of subjects were Chinese patients) [2].

Results from SURPASS 1-5 studies

In terms of weight loss, Tirzepatide achieved an average weight reduction of 21.1% over 72 weeks in Phase III clinical trials. By 84 weeks (72 weeks + 12 weeks of intensified lifestyle intervention), the total average weight loss with Tirzepatide treatment reached a significant 26.6% (29.2kg) [3,4].

On May 31st, the results of the first Chinese multicenter study on the efficacy and safety of Tirzepatide in the treatment of overweight and obesity (SURMOUNT-CN) were also published in JAMA.

SURMOUNT-CN included overweight (BMI≥24kg/m²) Chinese adults with obesity (BMI≥28kg/m²) or at least one comorbidity. The study compared the efficacy and safety of Tirzepatide with placebo in weight loss, based on a low-calorie diet and increased physical activity.

Image source: Reference [5]

The results showed that at week 52, the average weight reductions in the 10mg group and 15mg group were 13.6% (12.3kg) and 17.5% (16.1kg) respectively, both superior to the placebo group's 2.3% (2.1kg). The average waist circumference reductions from baseline were 11.4cm and 14.5cm, superior to the placebo group's 2.6cm.

In terms of safety, the most common adverse events during treatment were gastrointestinal reactions, mostly mild to moderate, with few events leading to treatment discontinuation (<5%).

Furthermore, cardiovascular metabolic indicators in the treatment group, including fasting blood glucose, insulin, very low-density lipoprotein cholesterol, triglycerides, systolic and diastolic blood pressure, all showed significant improvements compared to the placebo group.

A Hundred Billion Dollar Market, Just the Beginning of Competition

Phenomenal drugs often lead to the rise of a field. Last year, Morgan Stanley predicted that driven by the "double giants" Semaglutide and Tirzepatide, the annual sales of such drugs would exceed $100 billion by 2030. Just half a year later, BMO Capital Markets raised the expectation to $150 billion [6].

Image Source: Reference 6

With such a huge population base, the Chinese market is a battleground. According to Frost & Sullivan's forecast, the market size of GLP-1 drugs in China will exceed 50 billion RMB by 2030.

Currently, the domestic pricing of Tirzepatide has not been disclosed, while the monthly treatment price in the United States (4 pens) is about $974 (approximately 7,047 RMB). In the first quarter of this year, Novo Nordisk's Semaglutide products sold over $6 billion, and Eli Lilly's Tirzepatide also generated a total revenue of $2.324 billion, accounting for 26% of Eli Lilly's total revenue.

From Liraglutide, Dulaglutide to Semaglutide, and Tirzepatide, the hot road of GLP-1 receptor agonist drugs, the leading "double giants" are undoubtedly the biggest beneficiaries at present.

Now, the market for GLP-1 receptor agonist drugs in China is not only dominated by the "double giants".

In addition to Eli Lilly and Novo Nordisk, domestic companies are also actively entering the GLP-1 drug market, including Jiangsu Hengrui Medicine, CSPC Pharmaceutical Group, Innovent Biologics, and Huadong Medicine. In May of this year, Hengrui Medicine just announced its exclusive rights to develop, produce, and commercialize GLP-1 innovative drugs with independent intellectual property rights globally outside Greater China, completing an overseas transaction at a high price of $6 billion.

With rivals ahead and new players lurking, the approval of Tirzepatide for weight loss indication is just the beginning: in China's hundred billion dollar "weight loss injection" market, the "double giants" gather, and domestic drugs compete.

How the legend continues remains to be seen.

Planning: Yun Ye | Supervision: carollero, gyouza

Image Source: Reference 7

References:

[1] https://mp.weixin.qq.com/s?__biz=MzAxMjM5NDU5OQ==&mid=2649721210&idx=1&sn=fadb7a1bfe34cc270ea989bdba4b19f5 [2] https://www.lilly.com.cn/index.html#/?path=new_release&aid=358

[3] Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial [published online ahead of print, 2023 Oct 15]. Nat Med. 2023;10.1038/s41591-023-02597-w. doi:10.1038/s41591-023-02597-w

[4] https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-shows-additional-211-weight-loss-after-12

[5] Zhao L, Cheng Z, Lu Y, et al. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA. Published online May 31, 2024. doi:10.1001/jama.2024.9217

[6] https://www.biospace.com/article/obesity-market-to-reach-150b-as-demand-grows-supply-stabilizes-reuters/

[7] https://mp.weixin.qq.com/s_biz=MzAxMjM5NDU5OQ==&mid=2649721210&idx=1&sn=fadb7a1bfe34cc270ea989bdba4b19f5

Author: Jack Ma, Source: DXY， Original Title: "Major News! Eli Lilly's 'Weight Loss Injection' Receives Latest Approval in China, Is Simcere's Strongest Competitor Here?"