Obesity drug tirzepatide approval in China strengthens market position amid GLP-1 agonist competition: GlobalData

Eli Lilly’s tirzepatide (Mounjaro) has recently been approved by the National Medical Products Administration (NMPA) for treating obesity. This approval, based on the positive results from the SURMOUNT-CN clinical trial, makes tirzepatide the first dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist approved for obesity treatment in China, which is expected to enhance its market positioning in the country, says GlobalData.

Benemae Pharmaceutical’s benaglutide injection (Feisumei) was the first innovator approved for obesity in July 2023 in China followed by Novo Nordisk’s diabetes therapy semaglutide (Wegovy) in June 2024. Both are GLP-1 receptor agonists. All three drugs are available as once-weekly subcutaneous injections, with semaglutide also available in a daily oral formulation.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments, “The approval of Eli Lilly’s tirzepatide in China is timely, given the rising obesity rates. This innovator treatment can significantly impact obesity management. Tirzepatide’s dual mechanism mimics GLP-1 and GIP hormones, potentially enhancing weight loss and blood sugar control. The back-to-back approvals of anti-obesity medications highlight China’s focus on providing access to innovator treatments to the country’s population.”

According to GlobalData Pharma Intelligence Center Epidemiology database, the total prevalent cases of obesity in China is expected to cross 45 million in 2024.

The National Health Commission of the People’s Republic of China launched a three-year “Weight Management Year” campaign in June 2024 as part of the broader Healthy China Action (2019-2030) and the Implementation Plan for the Prevention and Control of Obesity in Children and Adolescents.

Sahu adds, “China’s multi-faceted programs to improve public awareness and access to novel interventions reflect a strong commitment to both preventing and managing obesity across the country. This approval aligns well with the ongoing public health initiatives and could potentially lead to better health outcomes for many individuals.”

The global obesity market faces supply issues, prompting Chinese pharma companies to leverage the situation to develop GLP-1 biosimilars. In July 2023, China approved Huadong Medicine’s biosimilar of Novo Nordisk’s once-daily subcutaneous GLP-1 agonist injection liraglutide for obesity; a few more liraglutide biosimilars are in the pipeline. Eight semaglutide biosimilars are gearing up for market entry in China post-2026 patent expiry of semaglutide in 2026 in China, despite global validity until 2031. Tirzepatide’s US patent lasts until 2036, with no known biosimilars, even in China.

Moreover, benaglutide injection (Feisumei) was added to the “Recommended Catalogue of Innovative Pharmaceutical and Medical Device Products” in China in June 2024, potentially boosting its visibility, affordability, and accessibility.

Sahu concludes, “With many Chinese biosimilar versions of GLP-1 agonists gearing up to enter the market, the GLP-1 agonist therapies may become more affordable than tirzepatide. Overall, while the obesity competitive landscape in China may pose challenges in terms of domestic players and pricing, tirzepatide’s broader metabolic benefits due to its dual MoA, lack of current biosimilar competition and the growing demand for effective obesity treatments supported by favourable government attention, present a promising opportunity for its success in the market.”

Edits made by EP News Bureau