Novo Nordisk's Wegovy weight-loss drug approved in China

By Andrew Silver

SHANGHAI (Reuters) -Novo Nordisk's hugely popular weight-loss drug Wegovy has been approved in China, it said on Tuesday, the world's second-largest economy and the country estimated to hold the highest number of overweight or obese people.

The company will communicate details on pricing and availability when it launches, it told Reuters in a statement. Novo said in March it would initially target Chinese patients willing to pay out-of-pocket for the weekly injectable drug.

Raffles Hospital Beijing, a major hospital in the Chinese capital, might place an order around September, but concrete timing is uncertain, Rose Niu Wei, a marketing manager at the private hospital, told Reuters.

By 1000 GMT on Tuesday Novo's shares were up 1.5%, having earlier touched record highs that valued the company at nearly $490 billion.

The number of overweight adults in China, the world's second most populous country, is projected to reach 540 million by 2030, 2.8 times higher than 2000 levels, a Chinese public health study showed in 2020. Numbers who are obese are seen jumping 7.5 times to 150 million.

But Novo may have a much shorter time in the Chinese market to make the most of its early-mover advantage in weight-loss drugs.

Its patent on semaglutide, the key ingredient in Wegovy and its diabetes drug Ozempic, is set to expire in less than two years in China compared to in 2031 in Europe and Japan and in 2032 in the U.S, and local drugmakers are racing to develop generic or biosimilar versions.

Novo is also in the midst of a legal fight in China over the patent, an adverse ruling in which could make it lose its semaglutide exclusivity even sooner. That would make China the first major market where it is stripped of patent protection for the drugs.

Booming demand for Wegovy has propelled Novo's shares to record highs, and the company last year overtook LVMH to become Europe's most valuable listed company.

But its success has left Novo facing shortages and forced to limit the number of patients taking the once-weekly injection.

"At the moment capacity and not global demand is the main limit on how fast (sales volumes) can grow, and adding a huge Chinese market will only increase the need for more capacity," said Allan von Mehren, China economist at Danske Bank.

"It is hard to say how fast volumes can go up, but the potential should be big."

The group faces competition from rival Eli Lilly, whose diabetes drug tirzepatide received approval from China in May. Some analysts expect Zepound, the U.S. firm's weight-loss drug with the same active ingredient, will be approved in China this year or in the first half of 2025.

Both Eli Lilly and Novo are racing to increase production in a weight-loss market estimated to reach at least $100 billion globally by the decade's end. Both companies' obesity treatments belong to a class of drugs originally developed for diabetes known as GLP-1 agonists.

Novo announced on Monday a $4.1 billion investment to build a U.S. facility to fill injection pens for Wegovy and Ozempic.

Ozempic won approval from China in 2021, and Novo saw sales of the drug in the greater China region double to 4.8 billion Danish crowns ($698 million) last year.

At least two Chinese firms, Livzon Pharmaceutical Group and Hangzhou Jiuyuan Gene Engineering, have already applied to begin commercial sales of Ozempic copies.

Shares in Livzon finished unchanged, while major Jiuyuan Gene shareholder Huadong Medicine closed down 0.3%.

(Reporting by Andrew Silver; Editing by Tomasz Janowski, Miyoung Kim, Edwina Gibbs and Jan Harvey)