Recently, there has been new news in the field of GLP-1 (glucagon like peptide-1) weight loss.
Novo Nordisk announced that the National Medical Products Administration (NMPA) has approved the marketing application of Smegglutide Injection (trade name Novo Nordisk) for long-term weight management. This means that the "weight loss indication" of the original research company Megglutide has been officially approved in China.
According to the announcement, Novoying is suitable for long-term weight management of adult patients based on controlling diet and increasing physical activity. The initial body mass index (BMI) meets the following conditions: ≥ 30kg/m& sup2; (Obesity), or ≥ 27kg/m& sup2; To< 30kg/m& sup2; (Overweight) and the presence of at least one weight related comorbidities, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.
As for Smeaglutide injection, its indications for diabetes were listed in the United States in 2017, approved for listing in China in April 2021 (trade name: Novotel), and included in the national medical insurance catalog through negotiation that year.
Regarding the progress of the product's launch, a reporter from China Business Daily wrote to Novo Nordisk, stating that since the approval of Novo Nordisk, the company has officially launched the relevant process of drug supply according to the plan and will bring this heavyweight product into the Chinese market as soon as possible, benefiting obese patients.
In addition, Novo Nordisk said that the company also solemnly reminded that Novo Plus, which was approved for long-term weight management for adults and has not yet been listed, and Novo Plus, which has been listed in China for the treatment of adult type 2 diabetes, are prescription drugs. These two drugs are used separately to treat two diseases and cannot be substituted for each other. Prescription drugs have a strict approval process, and any indications must be based on rigorous clinical trials and approved by the National Medical Products Administration before they can be marketed.
Biomimetic drugs follow the trend
In terms of indications for obesity or overweight, Smegglutide was approved for marketing in the United States and Europe in 2021. With the overseas listing of weight loss indications and the approval of domestic diabetes indications, the risks and side effects of the use of smeglutide super indications were once alerted and prompted. In addition, in January this year, Novo Nordisk's Smeaglutide tablets for the treatment of type 2 diabetes have been approved for marketing in China.
In the field of weight loss drugs, the market layout and competition are already booming. No matter in the field of diabetes or obesity, all enterprises have already worked hard to develop drugs. In addition, in terms of domestic substitution, in April this year, the official website of the Drug Evaluation Center of the National Medical Products Administration showed that Hangzhou Jiuyuan Genetic Engineering Co., Ltd. submitted an application for the listing of Simeglutide injection "Jiyoutai", which is a domestically produced biological analogue of Simeglutide.
As the expiration date of Smegglutide compound patents approaches in China in 2026, on the one hand, it is the rapid pursuit of biologically similar drugs, and on the other hand, it is the ongoing patent war of Smegglutide.
In 2021, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. submitted an invalid patent application to the China National Intellectual Property Administration; In September 2022, Novo Nordisk Meiglutide GLP-1 compound patent was declared invalid by the China National Intellectual Property Administration, and Novo Nordisk subsequently appealed to the Beijing Intellectual Property Court. Novo Nordisk stated that there is no final conclusion on the invalidation case of the patent for Smegglutide compound, and it is currently being tried by the Intellectual Property Court of the Supreme People's Court. It is not convenient to comment on the specific details.
In November 2023, an article published on the official website of the Beijing Intellectual Property Court analyzed the examination of supplementary experimental data and confirmation of patent technology effectiveness, including the case of Smegglutide.
How to face market competition after the expiration of core patents? Novo Nordisk stated that every innovation breakthrough of the company is aimed at meeting the unmet medical needs of patients. At present, the number of diabetes patients in China is about 140 million, and the proportion of obese adults in China accounts for 16.4%. The current status of diagnosis and treatment is not optimistic, and only a small number of patients have been effectively controlled. For all those working in the pharmaceutical industry, the common aspiration is to help patients through continuous efforts. The company is full of confidence in GLP-1RA drugs. Novo Nordisk is a pioneer and leader in the GLP-1RA field, and will continue to lead innovative breakthroughs to benefit patients with diabetes, obesity and even more diseases.
The strongest opponent closely follows behind
In fact, the sales performance of Smegglutide worldwide is very impressive. According to Novo Nordisk's 2023 financial report, three products of Smegglutide (oral hypoglycemic Smegglutide tablets, weight-loss Smegglutide injection, and hypoglycemic Smegglutide injection) achieved sales of DKK 145.811 billion (approximately USD 20.9 billion) in 2023, of which the sales of weight-loss Smegglutide injection were DKK 31.343 billion (approximately USD 4.5 billion), a year-on-year increase of 407%. According to the Q1 2024 financial report, the total revenue of three products of Smegglutide was 42.2 billion Danish kroner (approximately 6.1 billion US dollars). Among them, the sales of the lightweight version of Smegglutide injection increased by 106% year-on-year, reaching 9.377 billion Danish kroner (approximately 1.3 billion US dollars).
In 2023, the revenue of the Smegglutide series products was second only to that of Merck's Keytruda, and the GLP-1 receptor agonist track products are also considered a strong competitor to the future global "drug king".
Lilly's Telposide has become a major competitor to Smegglutide. In November 2023, the obesity or overweight indication (trade name: Zepbound) of Tilposide was approved by the FDA for sale, priced 20% lower than Smegglutide, with sales reaching $175.8 million in just one month. In addition to the previously approved diabetes indications, the annual sales of Tilpoltide will reach 5.339 billion dollars in 2023.
In November 2023, Truveta, an American electronic health record (EHR) data and analysis company, announced a new comparative validity study. According to research results, the weight loss effect of Lilliputide is better than that of Smegglutide. At present, the indication for type 2 diabetes of tilpoleptide has been approved in China in May this year, and the weight loss indication will be accepted by NMPA in 2023.
In terms of the domestic layout of weight management drugs, Novo Nordisk stated that the approved GLP-1RA weekly formulation is the world's first and currently the only one used for long-term weight management, bringing multiple health benefits beyond weight loss. The oral smeglutide tablets for weight management are currently undergoing phase III clinical registration studies in China and have not yet been approved for marketing. In addition, CagriSema is a compound mixture of Smegglutide and a long-acting amylin analogue called Cagrelinide, and phase III clinical trials have been initiated in China.
Novo Nordisk stated that the company will focus on several directions, continue to improve innovation standards, meet diverse medical needs, explore joint action mechanisms (such as GLP-1/amylin), seek better therapeutic effects, reduce medication frequency, focus on body composition, maintain muscle content, assist in long-term weight management, and provide treatment plans that are both safe and tolerable.
Previously, sales of Smegglutide were once tight overseas, and Novo Nordisk has repeatedly announced the expansion of production capacity both domestically and internationally. On June 24th, Novo Nordisk announced an investment of $4.1 billion to expand its manufacturing capacity in the United States. Among them, the plan is to build a second filling and precision manufacturing plant in Clayton, North Carolina, USA, to enhance its ability to produce semaglutide related drugs.
Novo Nordisk told reporters that currently, Novo Nordisk mainly produces in Denmark. With Novo Nordisk serving an increasing number of patients, the GLP-1 injection product portfolio is facing huge market demand. Each production plant of the company is making every effort to ensure the supply of products that meet the needs of existing patients. From 2023 to 2024, Novo Nordisk will invest a total of over 23 billion US dollars to expand production capacity and respond to growing market demand. This is the largest investment in the history of the company.