On October 17, the National Health Commission issued the "2024 Edition of the Guidelines for the Diagnosis and Treatment of Obesity", which is the first authoritative guide for the multidisciplinary diagnosis and treatment of obesity in China, which is of great significance for standardizing the clinical diagnosis and treatment of obesity in mainland China and improving the homogeneity of obesity diagnosis and treatment in medical institutions.
The most important feature of this guide is that it has four categories of obesity. For a long time, obesity in China was defined as overweight with a BMI of 24 kg/m² and less than 28 kg/m², and obesity at or above 28 kg/m². However, this division is no longer suitable for the current obesity situation in the population. Therefore, the new guidelines continue to subdivide obesity into four grades: mild, moderate, severe, and very severe, so as to facilitate clinical symptomatic treatment.
In addition, due to the emergence of weight loss drugs in recent years, especially the emergence of GLP-1 drugs in the past two years, the new version of the guidelines also specially added a drug treatment part: when overweight and accompanied by at least one weight-related comorbidity, such as abnormal blood glucose, blood lipids, blood pressure, non-alcoholic fatty liver disease, obstructive sleep apnea syndrome, tumors and other diseases, it can be treated with combined use of weight-loss drugs.
This statement clearly lists GLP-1 drugs as one of the necessary drugs for diagnosis and treatment.
The new guidelines recommend a total of 5 drugs for the treatment of obesity. In addition to the traditional orlistat, the four products of liraglutide, benaglutide, semaglutide and tirpatide are all GLP-1 drugs. The Health Bureau noted that the indicators for the use of GLP-1 drugs have been relaxed, which means that more overweight people can use GLP-1 drugs to lose weight.
Expand the scope of application of GLP-1 drugs
BMI is one of the measures of obesity and is calculated by dividing weight (kg) by height (m) squared. In the past, the BMI of the Chinese adult population was carried out according to four grades: low weight, normal weight, overweight and obesity. However, with the improvement of national living standards, this evaluation standard is obviously not in line with the previous standard, and the "Guidelines" once again refine the assessment of obesity.
According to the guidelines, a BMI of 24 kg/m² and less than 28 kg/m² is considered overweight; Mild obesity is considered to be 28.0 kg/m² and less than 32.5 kg/m²; Moderate obesity at and below 32.5 kg/m²; Severe obesity is defined as 37.5 kg/m² and less than 50 kg/m². If the body weight exceeds 50 kg/m², it is considered to be extremely obese.
The Guidelines provide a variety of methods for the treatment of obesity, such as behavioral intervention, psychological intervention, and nutritional therapy, and also focus on drug treatment. It is explicitly mentioned that when overweight is accompanied by at least one weight-related comorbidity, and the goal of weight loss cannot be achieved with lifestyle interventions, bariatric drug therapy can be used in combination with lifestyle interventions.
This means that patients with a BMI of ≥ 24 can be treated with medication. This is slightly different from the previous statement when the State Food and Drug Administration approved the marketing of semaglutide for weight loss indications.
On June 25 this year, Novo Nordisk officially announced that the marketing application for semaglutide weight loss indication in China was approved, which is suitable for overweight and obese patients with an initial BMI of ≥ 30kg/m2, or a BMI between 27-30kg/m2 and at least one weight-related comorbidity (such as: hypertension, hyperglycemia, dyslipidemia, etc.).
Whether the BMI is 27 or 24, the nuances of the numbers can cause a huge difference in the number of people who apply. According to the latest version of the Guidelines, the scope of semaglutide for obesity will be greatly expanded.
The Health Knowledge Bureau noted that on October 14, Aimec issued an announcement that its wholly-owned subsidiary, Beijing Nobot Biologics, obtained the clinical approval for semaglutide injection issued by the State Food and Drug Administration, and the clinical indication was "BMI≥28kg/m2 (obesity) or ≥24kg/m2 and <28kg/m2 (overweight) with at least one overweight-related comorbidity".
This shows that the newly opened semaglutide weight loss clinical trial has actually reduced the scope of application to the line of "BMI24".
If the application scope of GLP-1 drugs is expanded, how many people can be covered? According to the data of the Guidelines, the prevalence of obesity in China in 2023 will be 16.4%, and the proportion of overweight people will be 34.3%. This means that the number of people who are "overweight" but do not reach "obesity" accounts for 17.9% of the total number of people, and the total number is more than that of obese patients.
The slight adjustment of the lower BMI limit from 27 to 24 will open up a huge market space for GLP-1 drugs.
Drug abuse remains serious
A market war is on the horizon
While recommending treatments, the guidelines also suggest side effects in bariatric patients using GLP-1.
According to the content of the guidelines, about two-thirds of patients discontinue the drug within 1 year due to various reasons such as drug side effects, financial burden, health insurance coverage, etc., and some studies have focused on different degrees of weight regain after GLP-1 discontinuation, but continued use of the drug can further reduce body weight.
However, for the "beautiful face" that is widely rumored in the outside world, the "guidelines" clearly point out that "there is no clinical evidence to show the therapeutic effect and potential risks of bariatric drugs on sarcopenia". It is only suggested that these patients should be alert to exacerbations of sarcopenia.
In addition, the guidelines suggest that there are differences in response to drug therapy in patients with obesity: some patients are unable to achieve clinically meaningful weight loss with drug treatment, and it is recommended to discontinue the drug.
In any case, the launch of the new version of the obesity diagnosis and treatment guidelines will greatly promote the clinical application of GLP-1 drugs. There is no doubt that the bariatric indication has led to a dramatic expansion of the GLP-1 drug market. On October 11, Eli Lilly China announced that it will invest in the capacity upgrade of its Suzhou plant to expand the production of innovative drugs for type 2 diabetes and obesity. This is the second GLP-1 weight-loss drug approved in China after Novo Nordisk semaglutide.
Eli Lilly will expand the production of weight-loss drugs in China, also putting pressure on rival Novo Nordisk. Novo Nordisk's GLP-1 drug semaglutide injection has a weight-loss indication earlier than tirpatide was approved in China, and semaglutide tablets have also been approved for marketing.
Not only multinational pharmaceutical companies, but also a number of domestic pharmaceutical companies such as Hengrui and Innovent have also joined the competition for GLP-1 weight loss indications. According to the Insight database, more than 100 new GLP-1 drugs have entered the clinical stage in China. Domestic pharmaceutical companies have also laid out more than 20 products for weight loss indications.
However, the industry generally believes that the position of the market leader of GLP-1 drugs is difficult to shake in the short term, and domestic drugs must make greater efforts if they want to fight their way out of the chaos.
Written by Xiaomi
Editor丨Jiang Yun Jia Ting
Operations|XXIII
Illustration: Visual China
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