Novo Nordisk's Semaglutide - A Breakthrough in Obesity Management

2024-06-26

临床3期上市批准临床结果

Semaglutide, the active ingredient in Novo Nordisk's Wegovy®, is a GLP-1 receptor agonist GLP-1 receptor agonist that works by binding to and activating the GLP-1 receptor, thereby exerting its effects in the treatment of obesity. Given that the GLP-1 receptor is involved in the specific brain regions that regulate appetite, the application of Wegovy® in obese patients can significantly reduce hunger, enhance satiety, and decrease food cravings, thereby assisting patients in reducing caloric intake and achieving weight loss. Moreover, through genetic engineering, Wegovy® has been successful in extending its half-life to 7 days, allowing for a once-weekly dosing regimen, providing Chinese patients with a safe and convenient weight management solution.

Zhangkezhou, the Corporate Vice President of Pharmaceutical Quality at Novo Nordisk Greater China, stated that Novo Nordisk's research in the field of obesity treatment has spanned over 25 years, and the company has established a solid scientific foundation based on GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA therapy. The company is committed to comprehensively addressing the overall health of obese patients and aims to provide them with an integrated treatment plan. Looking ahead, Novo Nordisk will continue to lead the innovative breakthroughs in the field of obesity treatment to meet the diverse medical needs of Chinese patients.

Zhou Xiaping, the Global Senior Vice President and President of Novo Nordisk Greater China, emphasizes that as a global leader in the field of obesity treatment, Novo Nordisk is dedicated to changing the world's perception, prevention, and treatment of obesity. Coinciding with Novo Nordisk China's 30th anniversary, Wegovy® as the company's latest innovative drug introduced to China will effectively address the unmet medical needs in the field of obesity treatment in China. The company is grateful for the support and guidance from the National Medical Products Administration and relevant government departments in accelerating the introduction of innovative drugs to China, as well as the contributions of researchers and participants in the clinical trials.

Novo Nordisk will uphold its mission of "driving change and working together to overcome serious chronic diseases" and focus on patient-centricity, accelerating innovation, and diversifying and comprehensively contributing to the prevention and treatment of chronic diseases in China, supporting the "Healthy China 2030" initiative.

It is hereby declared that the approved Wegovy® (for long-term weight management in adults) and the already marketed Ozempic® (for the treatment of type 2 diabetes in adults) are both prescription drugs, targeting different diseases and cannot be substituted for each other.

About Wegovy® (semaglutide injection for long-term weight management)

Wegovy® is the world's first and currently the only once-weekly GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA GLP-1RA for long-term weight management, providing not only significant weight loss but also multiple health benefits. Wegovy® has been launched in over 10 countries and regions globally.

Wegovy® is indicated for long-term weight management in adults with an initial body mass index (BMI) of:

- BMI ≥ 30 kg/m² (obesity)

- BMI 27 kg/m² to ² (overweight) with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

Wegovy® can achieve an average weight loss of 17% (16.8 kg) and provide multiple health benefits, including reduced waist circumference, decreased visceral fat, improved lipid profile, and delayed progression to type 2 diabetes. In the global STEP clinical trial series covering over 25,000 overweight and obese participants, as well as real-world data studies, Wegovy® has demonstrated good safety and tolerability. Its active ingredient, semaglutide, has up to 94% structural homology with human GLP-1 and has been extensively validated for its safety, used by 5.4 million patients globally. The most common adverse reactions of Wegovy® are mild to moderate transient gastrointestinal events.

About the STEP Clinical Trial Series

The STEP clinical trial series for Wegovy® (semaglutide injection for long-term weight management) started in June 2018 and has completed 14 trials to date, including 12 global Phase 3 trials, 1 regional Phase 3 trial in East Asia, and 1 regional Phase 3 trial primarily in China. These trials have study durations of 11-24 months, with an average maximum treatment period of 34 months, aiming to evaluate the efficacy, safety, and other health benefits of Wegovy® in the long-term weight management of adults. Overall, the STEP clinical trial data have shown that Wegovy® can significantly reduce the weight of adult overweight and obese patients across different regions, ethnicities, ages, and genders, with or without type 2 diabetes, with an average weight loss of 17% (16.8 kg), and has demonstrated good safety and tolerability.