Can "Slimming God medicine" cure kidney disease? Novo Nordisk announces promising new GLP-1 drug development
Lily8911
发表于 2023-10-11 21:38:13
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On October 10, Novo Nordisk announced that the Phase 3 clinical trial of Simeaglutide to treat kidney failure and chronic kidney disease in patients with type 2 diabetes was stopped nearly a year early after an interim analysis showed the trial was successful - the interim data was summarized by the Independent Data Monitoring Committee (IDMC) overseeing the study. The efficacy has reached the predetermined target of early termination of the trial, so it is recommended to stop FLOW clinical. Clinical results for Novo Nordisk are still blind, and data are expected to be available in the first half of 2024.
The trial is a randomized, double-blind, parallel-to-group, placebo-controlled efficacy trial that was launched in 2019 and has been conducted in more than 400 study sites in 28 countries with a total of 3,534 participants to test whether the drug semaglutide can delay the progression of chronic kidney disease and reduce the risk of death from kidney and heart problems.
The drug used in the trial was Ozempic, a weight loss drug made by Novo Nordisk that uses semaglutide as its active ingredient.
▌ Diet pills are a panacea?
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which can stimulate insulin secretion, inhibit glucagon secretion, delay gastric emptying and reduce appetite, and ultimately achieve the effect of lowering blood sugar and weight loss. The active ingredient of Novo Nord's two diet drugs Ozempic and Wegovy is Semaglutide, and both have been approved in Europe and the United States for hypoglycemic and weight loss indications.
In addition to cardiovascular protection, Semaglutide is also being explored for additional indications. In addition to kidney trials, Semaglutide has previously shown promising results in stage 3 heart failure trials. It is also exploring indications for non-alcoholic steatohepatitis, Alzheimer's disease, peripheral artery disease, and whether it can treat alcohol addiction.
Among them, the study of whether Semaglutide has an effect on Alzheimer's disease has attracted the most attention. A related literature review in 2022 indicated that GLP-1 receptor agonists, including Semaglutide, reduce the most common neuroinflammatory and oxidative stress responses in Alzheimer's disease and provide neurotrophic effects in animal models of Alzheimer's disease. The authors note that these conclusions need to be confirmed in clinical trials.
In addition, GLP-1 has been shown for years in preliminary clinical studies to reduce drug and alcohol intake in animals, and researchers are testing whether Novo Nordisk's Ozempic can extend these results to humans.
Novo Nordisk's "rich country" capacity shortage may persist this year
Last year, Simeiglutide injection sales reached $10.8 billion, accounting for nearly 44% of Novo Nordisk's total annual sales, and the high price of the drugs themselves (currently 0.25mg/0.5ml*4 boxed Wegovy injection costs about $1,300), the creator of Simeiglutide, the Danish pharmaceutical company Novo Nordisk is now "rich."
The market value of Denmark's largest company has risen by more than a third so far this year, with Novo Nordisk's (NVO.US) worth more than $415 billion at press time, while Denmark's 2022 gross domestic product (GDP) is about $405.5 billion, according to the latest data from China's foreign ministry.
The Simeaglutide diet drug exploded, exacerbating its supply shortage. Novo Nordisk stopped some advertising of the drug in the United States in May; In September, Novo Nordisk extended the initial dose limit for Wegovy. Weight-loss drugs such as Wegovy are likely to remain hard to come by this year as demand outstrips manufacturers' ability to produce them.
▌ Weight-loss drug stocks remain active
In the secondary market, the concept stocks of diet drugs are still active, and since the National Day, Changshan Pharmaceutical and Haofan Biology have risen by more than 10%. Today, as of the close of noon, Uningwei, Baihua Pharmaceutical, Huasen Pharmaceutical rose more than 10%.
Compared with concept stocks such as Uningwei, there are some listed companies that have clearly entered the diet drug industry chain or diet drugs have been approved today's stock price performance is "dwarfed".
From the industry side, Nuotai Biology has applied for the registration of Simeiglutide apis, Wuxi Apptech (He Whole Pharmaceutical), Kelaiying's peptide research and development platform heavy projects continue to promote, Shengnuo Biology is also a leader in peptide drug research and development and production, Jiuzhou Pharmaceutical is also actively expanding the relevant business layout.
In addition, the Chinese patent of Simeaglutide will expire in 2026, and a number of companies have been developing related generic drugs, and Lizon Group has been following up research and development. In addition, the Chinese patent of Liraglutide, another GLP-1 drug that occupies a larger market share, has expired, and Huadong Medicine, Hanyu Medicine, and Tonghua Dongbao have submitted marketing applications, among which Huadong Medicine has submitted marketing applications for obesity indications.
Sinolink Securities analyst Wang Ban said that GLP-1 drug market prospects, after a preliminary calculation, GLP-1 drugs in diabetes patients in the application of the market space is expected to exceed 25 billion yuan, GLP-1 drugs in obesity patients in the application of the market space will exceed 20 billion yuan.
It is foreseeable that with the further expansion of the scope of indications, GLP-1 drugs represented by Semaglutide will win a broader market space.
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