Eli Lilly’s Tirzepatide approved by NMPA in China, boosting market position

New Delhi: Eli Lilly’s obesity drug, tirzepatide (marketed as Mounjaro), has recently received approval from the National Medical Products Administration (NMPA) in China for the treatment of obesity.

This marks a significant milestone as tirzepatide becomes the first dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist to gain such approval in the country. The decision follows positive results from the SURMOUNT-CN clinical trial and is expected to strengthen Eli Lilly’s position in the competitive obesity treatment market.

Sasmitha Sahu, Pharma Analyst at GlobalData, highlights, “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.”

GlobalData estimates that the number of prevalent obesity cases in China will surpass 45 million by 2024. In response to this growing health challenge, the National Health Commission of China has launched a three-year “Weight Management Year” campaign as part of its broader Healthy China Action (2019-2030) initiative. This campaign aims to improve public awareness and access to obesity management interventions.

Tirzepatide’s approval comes at a time when the obesity market in China is becoming increasingly crowded. Benemae Pharmaceutical’s benaglutide injection (Feisumei) was the first innovator drug for obesity to be approved in July 2023, followed by Novo Nordisk’s GLP-1 receptor agonist, semaglutide (Wegovy), which received approval in June 2024. Both benaglutide and semaglutide are available as once-weekly subcutaneous injections, with semaglutide also offered in a daily oral form.

In addition to international competition, Chinese pharmaceutical companies are exploring opportunities in the obesity market by developing GLP-1 biosimilars. Huadong Medicine’s biosimilar of Novo Nordisk’s liraglutide, approved in July 2023, is one such example, with additional liraglutide biosimilars in development. Moreover, eight semaglutide biosimilars are preparing for market entry post-2026, following the patent expiration of semaglutide in China. Tirzepatide, however, holds a US patent until 2036 with no known biosimilars in development.

Furthermore, benaglutide injection (Feisumei) was recently added to China’s “Recommended Catalogue of Innovative Pharmaceutical and Medical Device Products,” which could enhance its visibility 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 favorable government attention, present a promising opportunity for its success in the market.”