Monday, 2024 June 17

Chinese regulators greenlight Eli Lilly’s tirzepatide diabetes drug

On May 21, the National Medical Products Administration (NMPA) announced that Eli Lilly’s diabetes drug tirzepatide has been approved for the Chinese market. The approved indication is specifically for blood glucose control in adult patients with Type 2 diabetes. Additionally, the highly anticipated application for the weight loss indication was accepted by the NMPA last August.

This approval for the glucose-lowering indication in China is primarily based on Eli Lilly’s SURPASS series of trials for Type 2 diabetes, as well as the pivotal Phase 3 SURPASS-AP-Combo trial conducted in the Asia-Pacific region. In the SURPASS-AP-Combo trial, approximately 83.4% of the participants were Chinese patients. According to the trial results, after 40 weeks of treatment, patients using Mounjaro—a brand of tirzepatide—were not inferior to those using insulin glargine in terms of reducing glycated hemoglobin (HbA1c) levels and weight loss.

Eli Lilly’s “mounjaro” brand tirzepatide injection pen. Image source: Eli Lilly

Eli Lilly told 36Kr that the price of tirzepatide has not yet been determined and will be announced in the fourth quarter of this year when it is launched. Overseas, the monthly cost of the glucose-lowering version of Mounjaro and the weight loss version Zepbound is USD 1,023 and USD 1,059, respectively.

Tirzepatide is the world’s first approved dual-target GLP-1 drug, with its biggest selling point being its efficacy and the comparative trials with semaglutide. In the glucose-lowering indication, based on the results of the SURPASS trials, for Type 2 diabetes patients with poor glycemic control on metformin, the 5-, 10-, and 15-milligram doses of tirzepatide were all more effective in reducing HbA1c levels than semaglutide.

In the weight loss indication, according to a trial announced by Truveta Research at the end of 2023, which included nearly 18,000 overweight and obese patients over a period of almost a year and a half, participants taking tirzepatide were 1.8 times more likely to lose 5% of their body weight and six times more likely to lose 10% of their body weight compared to those taking semaglutide. This potential efficacy has led the market to believe that tirzepatide could potentially surpass semaglutide.

Infographic on GIP and GLP-1 by Eli Lilly.

According to Eli Lilly’s financial report, Mounjaro was first approved by the US Food and Drug Administration (FDA) in May 2022, and its sales in the first quarter of this year have reached USD 1.8 billion. Zepbound, which was first launched in the US in November last year, achieved sales of USD 517 million in the first quarter of this year, exceeding Wall Street’s sales expectations. Combined, the two products contributed 26% of Eli Lilly’s revenue for the first quarter.

Additionally, data analytics company GlobalData predicts that, in the future, tirzepatide could become the best selling drug in the obesity and diabetes market, with sales potentially reaching USD 27 billion by 2029.

Despite the general recognition of tirzepatide’s potential for volume expansion, some industry insiders believe that it remains uncertain whether dual-target drugs can disrupt the current GLP-1 market dominated by semaglutide.

An unnamed founder of a GLP-1 concept company pointed out to 36Kr that one aspect is the market brought by the expansion of indications, such as in the important cardiovascular disease direction, where semaglutide was approved in the US this March for the treatment of adult cardiovascular death, heart attack, and stroke risk. Even if tirzepatide starts clinical trials now, there would be a gap of about 4–5 years.

On the other hand, as GLP-1 products expand into the weight loss market, consumer versions require stricter safety standards. In this context, tirzepatide still lacks comprehensive long-term safety data. Moreover, there are concerns about whether the positive outcomes seen in clinical trials can be consistently replicated in actual scenarios. Additionally, the actual demand for significant weight loss in the general population might influence how many consumers are willing to adopt this treatment. These factors could affect the overall market acceptance and success of tirzepatide.

However, there is no doubt that in the face of a market opportunity that is rare in decades, the development of dual-target drugs has undoubtedly become a key competitive point in the GLP-1 market. According to 36Kr, statistics show that there are nearly 50 GLP-1 and GIP dual agonist drugs under development globally. Besides Eli Lilly, more than ten companies worldwide have advanced GLP-1 dual-target pipelines to the second phase of clinical trials, including Novo Nordisk.

Among Chinese companies, those with faster progress include Innovent Biologics, Hengrui Pharmaceuticals, and BrightGene. Innovent Biologics’ mazdutide achieved all primary and key secondary endpoints in its Phase 3 clinical trial for the weight loss indication disclosed early this year and is applying for market approval. Most other domestic dual-target drugs under development have not reached the third phase of clinical trials, showing a significant overall gap.

KrASIA Connection
KrASIA Connection
KrASIA Connection features translated and adapted high-quality insights published on 36Kr.com, the largest and most influential technology portal in Chinese language with over 150 million readers across the globe.
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