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  • Shaanxi YXchuang Biotechnology Co., Ltd

  •  [Shaanxi,China]
  • Business Type:Manufacturer , Trade Company
  • Main Markets: Africa , Americas , Asia , Caribbean , East Europe , Europe , Middle East , North Europe , Oceania , Other Markets , West Europe , Worldwide
  • Exporter:61% - 70%
  • Certs:COS, HACCP, ISO/TS16949, ISO9001, ISO9002, ACS, EMC, PSE, REACH
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Shaanxi YXchuang Biotechnology Co., Ltd

Home > News > Supply of peptides and polypeptides
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Supply of peptides and polypeptides

There's a lot of new news in the field of diet pills. Lilly's GLP-1 (glucagon-like peptide-1) drug Telpotide was approved for weight loss in the United States on November 10 and will soon go on sale, competing with Novo Nordisk's GLP-1 receptor inhibitor Semaglutide in the weight loss market. Novo Nordisk announced on Nov. 10 that it plans to expand its production capacity in the coming years to include Wegovy, the celebrity weight-loss drug. Corresponding to the expansion of pharmaceutical production capacity, some domestic enterprises are also expanding the production capacity of raw materials. On November 8, Eli Lilly announced that the U.S. Food and Drug Administration approved tilpotide (trade name "Zepbound") for weight loss or obesity. It is the first and only glucose-dependent insulin-stimulating polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (GIP/GLP-1 receptor agonist) and is injected once a week. In terms of diabetes indications, in May 2022, tilpotide was first approved for listing in the United States, and then in the European Union, Japan and other countries. In September 2022, Lilly submitted the application for registration of the drug for the treatment of blood glucose control in adults with type 2 diabetes in China, which is now under review. Eli Lilly disclosed financial data show that tilpotide (diabetes indication) sales of $1.548 billion in the first half of this year, ranked 50th in the global drug sales TOP100 list. In terms of weight loss indications, in October 2022, the FDA granted telpotide fast-track status for indications to improve long-term weight management (based on a low-calorie diet and increased physical activity) in overweight adults who are obese or have at least one comorbid condition, and it was approved for marketing in the United States on November 8 this year. In the domestic market, Eli Lilly also submitted an application for the listing of weight loss indications in August this year. In addition, Lilly is conducting clinical trials for the tilpotide weight loss indication head-to-head emaglutide, positive "hard" emaglutide. Not only that, the price of tilpotide is also 20% lower than Simaglutide, and the battle for "weight reduction medicine king" has been opened. Weight loss drug production capacity is limited, enterprises accelerate the expansion of production in the global market, since the approval of the weight loss indication, Simaglutide has been in the GLP-1 class of drugs fire "circle", once in as long as a year in short supply. Due to the limited supply of Simeaglutide Wegovy (weight loss indication), many obese patients began to use Simeaglutide Ozempic (diabetes indication) as an alternative, resulting in a shortage of medicines for diabetes patients. As a result, Novo Nordisk has had to put in place a number of restrictions that prioritize the supply of the drug to diabetics. Novo Nordisk expects these restrictions to remain in place until 2024. According to Novo Nordisk's third quarter earnings data, Wegovy sales of 21.729 billion Danish kroner (about $3.1 billion), an increase of 481%. In the third quarter in particular, Wegovy grew rapidly, with sales reaching 9.6 billion Danish kroner (about $1.36 billion). Market demand exceeded expectations, capacity constraints prevented rapid product volume, and Novo Nordisk soon announced plans to expand production. In June, Novo Nordisk announced plans to invest DKK 15.9 billion from 2023 to expand the company's existing API manufacturing facility in Denmark to enhance Novo Nordisk's ability to meet future market demand and to position its future product portfolio in the field of severe chronic diseases. Novo Nordisk announced on November 10 that it plans to invest more than DKK 42 billion (about $6 billion) starting this year to expand its plant in Denmark to produce its current and future portfolio of products for serious chronic diseases. This investment will enhance its capabilities for future market demand, including GLP-1 products. However, these construction projects will be completed from the end of 2025 to 2029. With the project years away from production, Novo Nordisk will need to find other ways to expand capacity. In this year's first quarter earnings report, Novo Nordisk made it clear that it will open two new CMO production lines this year. In April, Wegovy's second contract manufacturer also started production, which will boost Wegovy's supply capacity. With Lilly's telpotide approved as a weight loss indication, the drug will compete with Semaglutide in the weight loss market. Although some analysts predict that telpotide could exceed $50 billion in annual sales, it would surpass Novo Nordisk's Semaglutide drugs Ozempic and Wegovy. But to achieve rapid product sales volume, Lilly is bound to have more layout in capacity and supply. In North Carolina, Eli Lilly is investing $4 billion in two plants to double production of parenteral peptides containing tilpotide by the end of 2023, the Wall Street Journal reported. One of the plants has already started production. Lilly said it is actively adding capacity. In the face of the expansion of the production capacity of pharmaceutical companies, domestic API companies are also waiting in the wings. According to the information published by the drug evaluation center of the State Food and Drug Administration, there are four domestic enterprises for the record of Simeaglutide apis, including Tianma Pharmaceutical, Nuotai Biological, Jianxiang biological, Pai peptide biological. When responding to investors on July 24 this year, Nortai Biological mentioned that the production of Simeaglutide apis is mainly carried out by workshop 106, and the phase I project of Workshop 106 has been put into use. The "106 peptide API workshop Technical transformation Project" is currently in progress as planned, and is expected to reach the usable state by the end of October 2023, and the new production line can meet the large-scale production of polypeptide apis such as Simaglutide, the company's key varieties. In addition, a number of companies are deploying semaglutide apis. Prop Pharmaceutical said that Simaglutide has completed technical research and development, and chemical synthesis and biological methods have been laid out. In April last year, Puli Pharmaceutical began to develop the Simeaglutide project, including Simeaglutide excipient SNAC, Simeaglutide apis and Simeaglutide preparations. Hanyu Pharmaceutical replied to investors on September 1, said that Simaglutide apis have been declared in the United States DMF, Simaglutide injections and oral preparations in the United States are actively preparing for the declaration, Simaglutide in the domestic declaration is progressing as planned. Up to now, no enterprise has registered tilpotide API in China. Nortai Biological said on the investor interactive platform on June 9 this year that tilpotide apis were in the pilot stage and did not cooperate with Lilly. Hanyu Pharmaceutical also mentioned in its reply to investors that there is tilpotide in the layout of the peptide weight reduction/glucose reduction pipeline, but it did not mention the specific project progress.
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