On the last day of January, the global pharmaceutical industry once again saw the strong commercial power of GLP-1 drugs.
On January 31, local time, Danish pharmaceutical company Novo Nordisk released its 2023 annual report, which showed that the overall sales revenue of GLP-1 drug Smegglutide was 145.811 billion Danish kroner, approximately 21.2 billion US dollars. However, the sales of weight loss indications for Smegglutide alone surged by 406%, reaching 31.343 billion Danish kroner, approximately 4.6 billion US dollars.
According to incomplete statistics from The Paper, as of January 31st, there have been more than ten significant developments in GLP-1 drugs both domestically and internationally, many of which are related to Chinese pharmaceutical companies. The GLP-1 drug, which has been popular for a year in 2023, will continue to be highly sought after in the pharmaceutical industry in 2024, and competition among pharmaceutical companies will continue to escalate.
GLP-1 drug is making continuous progress domestically: Domestic GLP-1 weight loss drug will submit a marketing application
In 2023, a number of GLP-1 drugs were approved in China for the treatment of diabetes or weight loss, but they are all injection drugs. The development of oral drugs with more convenient use and storage has always been an important research and development direction for GLP-1 track players. In China, oral GLP-1 drugs have been taken the lead by Danish pharmaceutical company Novo Nordisk, directly opening up a new battlefield for oral GLP-1 drugs in the country.
On January 26, the information on the delivery of drug approval documents on January 26, 2024 released by the government affairs service portal website of the State Drug Administration showed that Novo Nordisk GLP-1 receptor agonist Smeglutide tablets were approved, but the indication was adult type 2 diabetes, not including weight loss.
Lilly, a multinational pharmaceutical company known as the "GLP-1 duo" alongside Novo Nordisk, is also increasing its research and development of oral GLP-1 drugs in China. On January 11, according to the clinical trial registration and information publicity platform of the National Drug Examination Center, Orforglipron, its oral GLP-1 agonist, launched a new phase III clinical trial in China, which is aimed at type II diabetes.
Domestic GLP-1 players also disclosed multiple developments in January. In terms of oral GLP-1 drugs, on January 24th, Xianwei Biotech announced that the first phase clinical trial of the long-acting GLP-1 agonist oral enoglutide tablets has been completed, and four trial groups have achieved positive results. Research has shown that the overall safety and tolerability of oral enoglutide are consistent with the known safety characteristics of peptide GLP-1 agonists. Pharmacokinetic studies have shown that oral enoglutide tablets have good absorption.
On January 9th, Xinda Biotechnology (1801. HK) announced to the public that the GLP-1/GCGR dual agonist, Masalidomide (R&D code: IBI362), achieved its primary endpoint and all key secondary endpoints in the first phase III clinical study (GLORY-1) of overweight or obese adult subjects in China. Xinda Biotechnology plans to submit its first new drug marketing application (NDA) for the weight loss indication of Masalidomide in the near future.
Multiple pharmaceutical companies have initiated head to head studies with the original research drug of Smegglutide
As the original research and development enterprise of Smegglutide, Novo Nordisk faces the challenge of producing more domestically produced biologically similar drugs. On January 16, China Biopharma (1177. HK) announced that Smeaglutide injection developed by the Group had launched the third phase clinical study in China, with the indication of type 2 diabetes. This study plans to enroll 492 patients to evaluate the efficacy and safety of smeglutide injection in patients with type 2 diabetes.
It is worth noting that according to the CDE clinical trial registration and information publicity platform, the above phase III clinical trial announced by the Chinese biopharmaceutical official is registered by Zhengda Tianqing Pharmaceutical. The name of this trial is the phase III clinical study on the efficacy and safety of Smeaglutide injection and Novotel in patients with type 2 diabetes. That is to say, this experiment is a head to head study of Smegglutide Injection from Chinese biopharmaceuticals and Novo Nordisk original research drug.
The industry is still discussing GLP-1 drugs, and the US FDA claims that the related drugs are not associated with an increase in suicidal thoughts
According to Frost& According to Sullivan's data, it is expected that the global GLP-1 market size will reach 28.3 billion US dollars by 2025, and the Chinese market size will reach 15.6 billion yuan. Since 2023, multinational pharmaceutical companies such as Roche, AstraZeneca, and Pfizer have been increasing their focus on the GLP-1 track. Merck, which has not yet established a presence, also expressed interest in GLP-1 drugs in January.
According to reports, the CEO of MSD stated at an industry exchange conference during the 42nd JPMorgan Healthcare Annual Conference that MSD is interested in the GLP-1 combination therapy plan and may seek a deal.
Jiang Ningjun, the director and chief strategic officer of Hengrui Pharmaceuticals who also attended the above conference, also mentioned GLP-1 drugs in his speech at the Asia Pacific conference, stating that Hengrui will explore various products such as oral GLP-1/GIP dual agonists and GLP-1/GIP/GCG triple agonists. GLP-1 will become one of Hengrui's next three potential heavyweight assets.
On January 22nd, Jiuyuan Gene in China submitted its application for listing on the Hong Kong Stock Exchange. Although the company's current business support is in the bone repair material market, due to the presence of biomimetic drugs such as Smegglutide in the research pipeline, Jiuyuan Gene has been dubbed a "domestic weight loss drug company".
According to the prospectus, the Phase III clinical study on Smeglutide II diabetes indication of Jiuyuan Gene has been completed, and it is expected to submit NDA in the first half of 2024, and obtain NDA approval for diabetes indication in the second half of 2025. In response to obesity and overweight, the Nine Source Gene's Smegglutide biosimilar drug obtained IND (Clinical Trial Application) approval in January 2024. The company is preparing for a Phase III trial, with patients expected to start the trial in 2024.
The lively GLP-1 is not without hidden worries. In 2023, EU regulatory authorities have successively warned about the association between semaglutide and thyroid cancer, as well as the potential risk of suicide. However, in January, the official statement of the US Food and Drug Administration (FDA) relieved the relevant pharmaceutical companies: preliminary evidence showed that the weight loss and diabetes drug megglutide were not associated with the increase of suicidal thoughts.
In addition to safety, the price of GLP-1 drugs has also become a topic of discussion. It is reported that the price of Ozempic, the diabetes indication of Smeglutide, owned by Novo Nordisk, rose by 3.5% in the United States, resulting in patients spending nearly 970 dollars on the drug every month. On January 23rd, Novo Nordisk China told Paper that this price adjustment is only applicable to the US market and will not affect Novo Nordisk's prices in the Chinese market.