China regulator accepts Novo Nordisk’s oral Wegovy marketing application

China’s National Medical Products Administration has accepted Novo Nordisk’s marketing application for oral Wegovy, formally beginning review for a weight-management indication but not granting final approval. The filing, based on the OASIS global Phase 3 program involving 1,300 overweight or obese adults, expands the Danish drugmaker’s competition with Eli Lilly in China’s emerging oral GLP-1 market. Novo’s oral semaglutide has also gained an early lead in the United States, with more than 176,000 weekly prescriptions versus 36,620 for Lilly’s competing product in recent market data. Novo reported $855 million in first-half revenue from oral semaglutide, compared with $98 million in first-quarter U.S. revenue for Lilly’s orforglipron. Novo is seeking further differentiation through Zenagutide, a dual GLP-1 and amylin-receptor agonist entering a South Korean Phase 3 trial after producing 14.6% weight loss over 36 weeks in a Phase 2 study of patients with type 2 diabetes. Lilly’s orforglipron offers more flexible dosing as a small-molecule, non-peptide drug, but the FDA has requested supplementary safety data on cardiovascular events, drug-induced liver injury and lactation exposure. Competition in China is expected to intensify if both companies secure approvals, alongside existing rivalry in injectable treatments.

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