The Zhitong Finance App learned that today, the official website of the Drug Evaluation Center of the China National Drug Administration showed that the marketing application for Novo Ying® tablets (simeglutide tablets) submitted by Novo Nordisk (NVO.US) for long-term weight management has been officially accepted.
This registration application is based on an extensive OASIS clinical research program. OASIS is a phase 3 clinical development project for simeglutide tablets, an obesity treatment drug administered once a day. This global phase 3 clinical program included 4 trials and included 1,300 adult patients from multiple countries and regions (including China) who are obese or overweight with at least one related complication.
As a complex chronic disease, obesity requires scientific diagnosis, treatment and long-term management. Different patients have diverse needs in terms of dosage methods and treatment experiences. Simeglutide tablets have achieved oral administration, breaking through the technical barriers that have been difficult for polypeptides to be taken orally for nearly a century. This is due to the absorption enhancer SNAC (N- (8- [2-hydroxybenzoyl] -amino) sodium octanoate). It can raise local gastric mucosal pH, reduce pepsin degradation of simeglutide molecules, and increase cell membrane fluidity to promote simeglutide transcellular transport and help the absorption of simeglutide molecules in the stomach. The absorption promoting effect of SNAC can increase the bioavailability of simeglutide molecules in the oral administration route by about 100 times.
Dr. Cai Yan, senior vice president of Novo Nordisk Global and President of Greater China, said, “After being deeply involved in the field of obesity for more than 30 years, Novo Nordisk continues to lead innovation to meet patients' individualized treatment needs with more diverse treatment options, and promote obesity treatment from focusing on changes in body weight numbers to focusing on overall health and long-term outcomes, and creating long-term health benefits for patients. Novo Ying® tablets are expected to provide patients with more convenient treatment options and help scientific and standardized weight management. We sincerely thank the researchers and test subjects for their contributions, and thank the Drug Administration for their guidance and support. We look forward to the progress of approval of this innovative drug and continue to promote its benefits to Chinese patients.”
Novo Ying® tablets are the world's first oral GLP-1 receptor agonist approved for weight management. They have now been approved for registration in the United States, the United Kingdom, the United Arab Emirates, Bahrain, and the European Union. Since its launch in the US in January 2026, the cumulative number of prescriptions has exceeded 5 million. According to the data, more than 80% of prescriptions are from people who have not previously used GLP-1 drugs [i], bringing new standardized treatment options to more patients.