Danish pharmaceutical company Novo Nordisk has secured China’s National Medical Products Administration (NMPA) approval for marketing its weight-loss drug Wegovy in China.
Wegovy is indicated for the treatment of people with a body mass index (BMI) of at least 30 or between 27 and 30 for those with one weight-related risk factor.
The weekly injectable drug will comprise semaglitude, the same key compound used in Ozempic, and will be marketed under the new brand name NovoCare in China
According to the Reuters report, Novo has a limited time to operate in the Chinese market, as the company’s patent on semaglutide would expire within two years in China.
Its patent on semaglutide is valid through 2031 in Europe and Japan and 2032 in the US.
Local drugmakers in China are rushing to develop generic or biosimilar versions.
China-based companies Livzon Pharmaceutical Group and Hangzhou Jiuyuan Gene Engineering have already applied to begin commercial sales of Ozempic copies.
Also, Novo is fighting a legal case in China over the patent, and an adverse ruling could force it to lose semaglutide exclusivity even sooner, said the publication.
Danske Bank China economist Allan von Mehren told Reuters: “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. It is hard to say how fast volumes can go up, but the potential should be big.”
Novo is competing rival Eli Lilly, whose diabetes drug tirzepatide received approval from China in May. Both drugs belong to the same class of diabetes drugs, known as GLP-1 agonists.
Both companies are looking to speed up their production in China, where the weight-loss market is estimated to reach up to $100bn by the end of this decade.
Recently, Novo announced its plans to invest $4.1bn in expanding its US manufacturing facility to enhance the production of Wegovy and Ozempic pre-filled injection pens.