Novo Nordisk to seek approval soon to sell Wegovy pill in China
Regulatory Plans and Competitive Landscape in China
By Andrew Silver
Novo Nordisk’s Strategy for Wegovy Pill Approval
BEIJING, June 16 (Reuters) - Novo Nordisk plans to seek Chinese regulatory approval for its Wegovy weight-loss pill "very soon," its CEO said on Tuesday, as it moves to catch up with rival Eli Lilly in the world's second-largest pharmaceutical market.
Market Potential for Weight-Loss Pills
Denmark's Novo and U.S.-based Lilly believe weight-loss pills could attract patients reluctant to use injections and are racing to expand use of drugs that have transformed obesity treatment and reshaped the global pharmaceutical industry.
CEO Statement on Submission Timeline
"We will be submitting oral Wegovy...for regulatory approval very soon...I would say a few months," Mike Doustdar, on his first visit to China since becoming Novo's CEO in August, told reporters.
Competition and Patent Landscape
Competition in China has intensified in recent years, with Pfizer and local firms including Innovent Biologics entering the market.
Doustdar said he expected competition from generic drugmakers from the second quarter of next year.
The patent for semaglutide, the active ingredient in Novo's blockbusters Wegovy and Ozempic, expired in China in March, though the company has regulatory data protection until early next year.
Barriers to Entry for Competitors
"One barrier to entry for the (weight-loss) tablet will also be the scaling of this, in the way that we're able to do. And I would think not many of our competitors will be able to that level, have the capabilities," he said.
Global and Local Approvals of GLP-1 Drugs
Novo has received early approval in the U.S. and Britain for its Wegovy pill and launched it in the U.S. this year. Lilly followed quickly, securing U.S. approval in April for its oral drug orforglipron.
In China, Lilly has moved first. The company said in March it submitted a marketing application for once-daily orforglipron to the Chinese regulator at the end of 2025.
Overview of GLP-1 Medicines
The rival drugs belong to a class known as GLP-1 medicines.
Market Share and Sales Data
The market share of weight-loss drugs in China is opaque, with firms including Innovent and Lilly not disclosing sales figures.
Sales of GLP-1 treatments in China through major e-commerce platforms Alibaba and JD.com totalled about 1.4 billion yuan ($207 million) in the first quarter, according to Jefferies.
(Reporting by Andrew Silver; Editing by Miyoung Kim, Mark Potter and Jacqueline Wong)
