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Novo Nordisk Secures Approval in China for Obesity Drug Wegovy

Driving demand up still further, Novo Nordisk has gained approval from China’s National Medical Products Administration (NMPA) for its obesity drug Wegovy, which will be marketed as NovoCare in China and consisting of the same compound, semaglutide, as that used in Ozempic.

In 2022, more than half of China’s adults were overweight or obese, with more people with type 2 diabetes and obesity than any country in the world. But with Novo’s patent on semaglutide set to expire within a couple of years, the company will have to maximize sales before a series of GLP-1 biosimilars enter the market.

Elsewhere, Novo has invested $4bn to expand its manufacturing and production site in Raleigh, North Carolina, to increase output of its weight-loss drugs. The investment will fund a new 1.4mn sq ft facility, doubling its current capacity from 2027.

The following article originally appeared in Fierce Pharma.

On the market for three years in China, Novo Nordisk’s diabetes drug Ozempic (semaglutide) is racing toward blockbuster sales in the world’s second most populous country. With that success in place, the Danish company looks to double down with its obesity treatment Wegovy.

On Tuesday, China’s National Medical Products Administration (NMPA) blessed Wegovy with marketing approval to treat people with a body mass index (BMI) of at least 30 or between 27 and 30 for those with one weight-related risk factor.

It will be marketed as NovoCare in China. The drug is the same compound, semaglitude, as that used in Ozempic.

In response to the nod, Novo’s share price increased by 3%.

Obesity is a growing problem in China. In 2022, more than half of the country’s adults were overweight or obese. China has more people with type 2 diabetes and obesity than any country in the world. In approving Wegovy, the NMPA cited its ability to achieve an average weight loss of 17% and the associated benefits it provides.

"Up to now, there is still a lack of effective clinical drug treatments for obese patients in China, and there is a huge medical need to be met," Chen Wei, of the Peking Union Medical College Hospital, said in a release: "In view of the clinical situation that there are very limited drugs approved for the treatment of obesity in China in the past 20 years, new medical weight loss drugs can provide patients with safe, effective and convenient treatment options."

Novo will have to act quickly to maximize sales of Wegovy in China however, as its patent on semaglutide is set to expire there in just two years—or even sooner if an upcoming court ruling goes against the company. As a result, drugmakers in China are set to flood the market as at least 15 GLP-1 biosimilar candidates are in development, according to a story reported earlier this month by Reuters.

In Europe and the United States, Novo has exclusive rights to semaglutide until 2031 and 2032 respectively.

The approval comes three months after Novo revealed that it was investing 4 billion yuan ($556 million) in its 30-year-old flagship manufacturing site in Tianjin, China., with the upgrades due for completion in 2027.

Last year, Novo more than doubled its China sales of Ozempic to 4.82 billion kroner ($693 million). The company now faces competition in the indication as last month the NMPA signed off on Eli Lilly’s dual action GLP-1/GIP diabetes drug Mounjaro (tirzepatide). The commercial name for the treatment in China is MuFengDa.

For more, please find the original story source here.