Novo Nordisk’s Wegovy Approved in China: Implications and Future Challenges

Approval in China:
Novo Nordisk's obesity drug Wegovy (semaglutide) has been approved by China's National Medical Products Administration (NMPA) for treating individuals with a BMI of at least 30 or between 27 and 30 with weight-related risk factors.

Market Impact:
The approval is significant given China's growing obesity problem, with over half of the country's adults being overweight or obese in 2022. Wegovy is expected to provide a much-needed effective treatment option.

Competition and Patent Issues:
Novo Nordisk faces a looming challenge as its patent on semaglutide is set to expire in China by 2026. This has prompted several Chinese drug manufacturers to develop generic versions, with at least 15 GLP-1 biosimilar candidates in development.

Market Dynamics:
The entry of generics could drive down prices, making treatments more accessible. Novo Nordisk also faces competition from international firms like Eli Lilly, which has recently received approval for its diabetes and weight loss drug Mounjaro in China.

Investment and Expansion:
Novo Nordisk has invested 4 billion yuan ($556 million) in its Tianjin manufacturing site, with upgrades expected to be completed by 2027. This investment aims to support the increased demand for its drugs in China.

Global Patent Timeline:
Novo Nordisk retains exclusive rights to semaglutide until 2031 in Europe and 2032 in the United States, providing a longer period of market exclusivity in these regions compared to China.

Future Developments:
Novo Nordisk is preparing to file late-phase data for a combination of insulin and semaglutide in the EU and China, but not yet in the US, indicating ongoing research and development efforts to maintain market presence.