Regulatory bodies in China give approval for the diabetes medication tirzepatide, developed by Eli Lilly.
In a significant development for the treatment of Type 2 diabetes and obesity, Eli Lilly's diabetes drug tirzepatide has been approved for the Chinese market. This dual-target GLP-1 drug, which has become a key competitive point in the GLP-1 market, is set to make waves in the Asia-Pacific region.
The approval is primarily based on the SURPASS series of trials for Type 2 diabetes and the pivotal Phase 3 SURPASS-AP-Combo trial, which was conducted in the Asia-Pacific region. Notably, approximately 83.4% of the participants in the SURPASS-AP-Combo trial were Chinese patients.
In the glucose-lowering indication, tirzepatide was more effective in reducing HbA1c levels than semaglutide for Type 2 diabetes patients with poor glycemic control on metformin. This efficacy has been a significant selling point for tirzepatide, making it the world's first approved dual-target GLP-1 drug.
In the weight loss indication, 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.
However, some industry insiders question whether dual-target drugs like tirzepatide can disrupt the GLP-1 market currently dominated by semaglutide. Semaglutide, which was approved in the US this March for the treatment of adult cardiovascular death, heart attack, and stroke risk, has created a significant lead in the cardiovascular disease direction.
Data analytics company GlobalData predicts that tirzepatide could become the best-selling drug in the obesity and diabetes market, with sales potentially reaching USD 27 billion by 2029. Overseas, the monthly cost of the glucose-lowering version of Mounjaro (a brand of tirzepatide) and the weight loss version Zepbound is USD 1,023 and USD 1,059, respectively.
Besides Eli Lilly, more than ten companies worldwide have advanced GLP-1 dual-target pipelines to the second phase of clinical trials. In China, Innovent Biologics has achieved all primary and key secondary endpoints in its Phase 3 clinical trial for the weight loss indication with mazdutide and is applying for market approval.
However, most other domestic dual-target drugs under development in China have not reached the third phase of clinical trials, showing a significant overall gap. The price of tirzepatide in China has not been determined and will be announced in the fourth quarter of this year. If tirzepatide starts clinical trials now for the same indication, there would be a gap of about 4-5 years.
The development of dual-target drugs, such as tirzepatide, has become a key competitive point in the GLP-1 market. As these drugs continue to advance through clinical trials and gain approvals, the landscape of the diabetes and obesity treatment market is set to change significantly.
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