Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced that it has received its first market approval from the National Medical Products Administration (NMPA) in China for Mounjaro (tirzepatide). The drug is indicated for the treatment of type 2 diabetes mellitus (T2DM) in patients who have poor blood glucose control despite treatment with metformin or sulfonylurea drugs. The approval specifies that Mounjaro should be used in conjunction with dietary modifications and physical activity.
Tirzepatide, the first dual GIP/GLP-1 receptor agonist to reach the market, has been approved in the US for the treatment of T2DM in May 2023 and obesity in December 2023. In China, the drug is marketed under the brand name Zepbound for obesity indications and is administered via subcutaneous injection.
The Chinese approval is supported by the positive results from the global pivotal Phase III SURPASS 1-5 study in T2DM patients, as well as the Asia-Pacific pivotal Phase III SURPASS-AP-Combo study, which included a significant portion of Chinese participants (83.4%). Both trials demonstrated that tirzepatide can significantly reduce HbA1c levels and average weight in T2DM patients, with an overall safety profile in the Asia-Pacific population consistent with the global population, and without any new safety signals. Additionally, the molecule is currently under regulatory review in China for long-term weight management.- Flcube.com
