Tides Express | Heavyweight! Simiglutide Injection Approved for Weight Loss Indications in China

Edited by the Peptide Biochemical Content Team
On June 25, 2024, Novo Nordisk announced that the new indication for Semaglutide Injection has been approved for marketing by the National Medical Products Administration (product name: Novo Nordisk) ®）， As an adjunctive therapy for a low calorie diet and increased physical activity, it is used in adult patients with an initial body mass index (BMI) of ≥ 30kg/m2 (obesity), or ≥ 27kg/m2 and<30kg/m2 (overweight), accompanied by at least one comorbidity associated with overweight.

The first GlP-1RA weekly formulation for long-term weight management, Novoying ® Approved in China

June 25, 2024 Novo Nordisk China

Beijing, China, June 25, 2024- Recently, the National Medical Products Administration (NMPA) approved the marketing application of Novo Nordisk’s research and production of Novo Nordisk’s Novo Nordisk (Semaglutide Injection for long-term weight management) in China. As the world’s first and currently the only weekly glucagon like peptide-1 receptor agonist (GLP-1RA) used for long-term weight management, Novoying is able to achieve an average weight loss of 17% 1 (16.8kg) 2 and bring multiple health benefits to patients beyond weight loss. Its safety has been widely validated. The approval of this innovative drug will provide a breakthrough healthy weight management plan for overweight and obese patients (with an initial BMI greater than or equal to 30kg/m2; or between 27kg/m2 and 30kg/m2, and at least one weight related comorbidities), opening up a new pattern of obesity treatment in China in a scientific, effective, and safe manner.

Semaglutide is a long-acting GLP-1 receptor agonist. GLP-1 not only promotes insulin secretion in a glucose concentration dependent manner, but also inhibits glucagon secretion; At the same time, it can also delay gastric emptying and reduce food intake through central appetite suppression, which is beneficial for lowering blood sugar and weight loss. Therefore, Smegglutide has multiple effects, including excellent hypoglycemic and weight loss effects, as well as clear cardiovascular benefits.
In August 2022, Novo Nordisk Semaglutide Injection completed the phase III clinical registration of weight loss indications in China (registration number: CTR202040). This study is a randomized, double-blind, international, multi center phase III clinical study, which aims to evaluate the efficacy and safety of smeglutide (2.4mg), which is injected subcutaneously once a week, in overweight/obese patients with or without type 2 diabetes, compared with the placebo group. A total of 300 patients were enrolled domestically, while 375 were enrolled internationally. The experiment was hosted by the General Hospital of the People’s Liberation Army of China, and the research leader was Professor Mu Yiming.
The main endpoints of the experiment were the change in weight from baseline at week 44 (%) and the proportion of patients who achieved a weight loss of ≥ 5% after week 44. Secondary endpoints include achieving weight loss of ≥ 10% and ≥ 15% after 44 weeks, as well as changes in waist circumference, systolic blood pressure, body function score, and body function domain score at 44 weeks.
In December 2017, Semaglutide injection (trade name: Ozempic) was approved by FDA for marketing to treat type II diabetes. In April 2021, Smegglutide Injection was first approved for sale in China (trade name: Novotech) ®）， It is used to assist diet and exercise to improve blood sugar control in patients with type 2 diabetes (T2DM).
In September 2019, Semaglutide oral tablet (trade name: Rybelsus) was approved by FDA to treat type II diabetes, and this dosage form was also approved in China in January 2024 (trade name: Novosi ®）。 In June 2021, the weight loss indication of Semaglutide (trade name: Wegovy) was approved by the FDA for marketing, becoming the first and only weekly GLP-1 receptor agonist used for weight management. This approval is based on the results of the STEP clinical project Phase IIIa, where after 12 weeks of subcutaneous injection of semaglutide once a week, the average weight loss of obese or overweight patients in the 2.4mg dose group was about 6%; Reduce weight by 17-18% at 68 weeks.
In May this year, Novo Nordisk released the latest research data on Wegovy for obese patients. The results showed that Wegovy can maintain significant weight loss for up to 4 years, while improving cardiovascular health regardless of how much weight loss patients experience.
As the best-selling single product in the GLP-1 field, Semaglutide’s three products achieved sales of 145.811 billion Danish kroner (21.201 billion US dollars) in 2023, second only to K Pharmaceuticals (25.011 billion US dollars).
According to the Q1 2024 financial report, three products of Semaglutide generated a total revenue of 42.2 billion Danish kroner (6.132 billion US dollars), with sales of Smegglutide’s injectable hypoglycemic drug Ozempic continuing to climb to 27.81 billion Danish kroner (4.041 billion US dollars), a growth rate of 43%; The sales revenue of Rybelsus, an oral hypoglycemic product, was 5.013 billion Danish kroner (728 million US dollars), a year-on-year increase of 17%; The sales of weight loss drug Wegovy doubled to 9.377 billion Danish kroner (1.363 billion US dollars).
About STEP series clinical trials
Nuoheying ® The STEP series clinical trial of Semaglutide Injection for long-term weight management began in June 2018 and has now completed 14 trials, including 12 global phase 3 clinical trials, 1 regional phase 3 clinical trial in East Asia, and 1 regional phase 3 clinical trial primarily in China. The study duration of the 14 completed STEP series clinical trials is 11-24 months, with an average treatment period of up to 34 months. Based on lifestyle interventions or intensified behavioral therapy, evaluate Novoying ® The efficacy, safety, and other health benefits of long-term weight management in adults. In general, the STEP series of clinical trial data show that no matter whether type 2 diabetes is combined or not, for adults with overweight and obesity in different regions, different races, different ages, and different genders, NovoPlus ® Both can significantly reduce weight, with an average weight loss of 17% (16.8kg), and have good safety and tolerance.
About Novo Nordisk
In December 2017, Semaglutide injection (trade name: Ozempic) was approved by FDA for marketing to treat type II diabetes. In April 2021, Semaglutide Injection was first approved for sale in China (trade name: Novotech) ®）， It is used to assist diet and exercise to improve blood sugar control in patients with type 2 diabetes (T2DM).
In September 2019, Semaglutide oral tablet (trade name: Rybelsus) was approved by FDA to treat type II diabetes, and this dosage form was also approved in China in January 2024 (trade name: Novosi ®）。 In June 2021, the weight loss indication of Semaglutide (trade name: Wegovy) was approved by the FDA for marketing, becoming the first and only weekly GLP-1 receptor agonist used for weight management. This approval is based on the results of the STEP clinical project Phase IIIa, where after 12 weeks of subcutaneous injection of smeglutide once a week, the average weight loss of obese or overweight patients in the 2.4mg dose group was about 6%; Reduce weight by 17-18% at 68 weeks.
In May this year, Novo Nordisk released the latest research data on Wegovy for obese patients. The results showed that Wegovy can maintain significant weight loss for up to 4 years, while improving cardiovascular health regardless of how much weight loss patients experience.
As the best-selling single product in the GLP-1 field, Semaglutide’s three products achieved sales of 145.811 billion Danish kroner (21.201 billion US dollars) in 2023, second only to K Pharmaceuticals (25.011 billion US dollars).
According to the Q1 2024 financial report, three products of Smegglutide generated a total revenue of 42.2 billion Danish kroner (6.132 billion US dollars), with sales of Semaglutide’s injectable hypoglycemic drug Ozempic continuing to climb to 27.81 billion Danish kroner (4.041 billion US dollars), a growth rate of 43%; The sales revenue of Rybelsus, an oral hypoglycemic product, was 5.013 billion Danish kroner (728 million US dollars), a year-on-year increase of 17%; The sales of weight loss drug Wegovy doubled to 9.377 billion Danish kroner (1.363 billion US dollars).
About STEP series clinical trials
Nuoheying ® The STEP series clinical trial of Semaglutide Injection for long-term weight management began in June 2018 and has now completed 14 trials, including 12 global phase 3 clinical trials, 1 regional phase 3 clinical trial in East Asia, and 1 regional phase 3 clinical trial primarily in China. The study duration of the 14 completed STEP series clinical trials is 11-24 months, with an average treatment period of up to 34 months. Based on lifestyle interventions or intensified behavioral therapy, evaluate Novoying ® The efficacy, safety, and other health benefits of long-term weight management in adults. In general, the STEP series of clinical trial data show that no matter whether type 2 diabetes is combined or not, for adults with overweight and obesity in different regions, different races, different ages, and different genders, NovoPlus ® Both can significantly reduce weight, with an average weight loss of 17% (16.8kg), and have good safety and tolerance.
About Novo NordiskNovo Nordisk was founded in 1923 and is a leading global biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to promote change to combat diabetes, obesity, rare blood diseases, endocrine disorders and other serious chronic diseases. To achieve this goal, we lead scientific breakthroughs, expand the accessibility of our company’s drugs, and are committed to preventing and ultimately curing diseases. Novo Nordisk has approximately 47000 employees in 80 countries and regions worldwide, providing products and services to over 168 countries and regions worldwide.