Recently, Hanyu Pharmaceutical announced that its independently developed GLP-1 Liraglutide Injection has been approved by the FDA for marketing as the first generic version and has officially landed in the United States.

As we all know, GLP-1 drugs have become the focus of the market in recent years due to their significant efficacy in reducing blood sugar and weight loss. However, precisely because of the skyrocketing demand, this type of drug has repeatedly faced problems of insufficient production and supply.

The launch of Hanyu Pharmaceutical's liraglutide generics in the U.S. market is not only an important breakthrough for Hanyu Pharmaceuticals in the international market, but also marks the imminent release of domestically produced liraglutide generics.

Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog that can activate human GLP-1 receptors, promote insulin secretion, inhibit glucagon secretion, delay gastric emptying, and Increases feelings of fullness, thereby lowering blood sugar and weight. Liraglutide was originally developed by Novo Nordisk and was launched in the European Union in 2009. It was subsequently launched in Japan and the United States in 2010. It entered the Chinese market in 2011 and was approved for use in adult patients with type 2 diabetes to control blood sugar (trade name : Novopower). In recent years, in addition to diabetes, liraglutide research areas have also involved obesity, neurological diseases, and cardiovascular system diseases. In December 2014, liraglutide was approved by the US FDA for weight loss indications.

Hanyu Pharmaceutical's liraglutide injection officially submitted an ANDA application in September 2021. In June 2024, this variety received tentative approval from the US FDA. In October 2024, liraglutide injection will usher in large-scale shipments. This order is a RMB 103 million preparation purchase order from Hikma announced by the company in 2023. This time, Liraglutide Injection adopted an external licensing cooperation model, and Hanyu Pharmaceutical received a double-digit share of sales profits. In addition to this order, Hanyu Pharmaceutical has received three purchase orders from Hikma Company in 2024, with amounts of 72 million yuan, 84 million yuan, and 77 million yuan respectively. In November 2024, Hanyu Pharmaceutical's zero-defect API production base once again passed the US FDA on-site inspection. Up to now, Hanyu Pharmaceutical has successfully passed the on-site inspection of cGMP standards of the US FDA, regardless of its API production base or preparation production base, and has successively received multiple overseas commercial batch orders for GLP-1 APIs and preparations. In addition to the formal approval by the FDA, Hanyu Pharmaceutical said that it has submitted a marketing application for liraglutide injection in China in October 2024 and has been accepted; in addition, Southeast Asia, South America, the Middle East and other countries will gradually enter the application process. .

According to Novo Nordisk’s annual report, due to the impact of semaglutide production capacity tilt, liraglutide (hyperglycemic version Victoza and Saxenda weight loss version) sales in the United States from 2021 to 2023 will be approximately US$1.62 billion and US$1.51 billion, respectively. US$970 million and US$970 million. Founder Securities said that as the first generic drug of liraglutide in the United States, assuming that the price of the product is reduced by 30% after approval, it can occupy about 20% of the market share; the agency predicts that Hanyu Pharmaceutical's liraglutide generic drug will be sold in the United States The peak is expected to reach US$135 million.

In the field of weight loss and hypoglycemic, in addition to liraglutide, Hanyu Pharmaceutical is also actively deploying other GLP-1 blockbuster products such as semaglutide, tilpotide, etc., and expanding through diversified product lines market share.

According to public data, the global liraglutide end market size in 2023 is US$5.991 billion, of which the US end market size is approximately US$3.204 billion, and the Chinese end market size is approximately US$197 million. Liraglutide shows great commercial potential in the North American market. People in North America have high awareness of the treatment of diabetes and obesity, and relatively sufficient health care expenditures, coupled with factors such as the large number of obese people, have driven the demand for the liraglutide market, and the market size is expected to be from 2024 to 2030. will continue to grow.

Currently, the main indications for liraglutide are type 2 diabetes and obesity, but researchers are actively exploring its application in potential therapeutic areas such as cardiovascular disease, non-alcoholic fatty liver disease (MASH), and neurodegenerative diseases. If These indications can be successfully approved, which will further expand the market space of liraglutide. In addition, new dosage forms and combination drugs are also potential points to continue to explore the value of liraglutide products, and some researchers are trying to explore them. In short, liraglutide, as an important drug, plays an important role in the fields of diabetes and obesity, and will continue to expand its value in clinical applications.

The number of diabetic patients in my country ranks first in the world, and the number of patients is expected to reach 150 million in 2025 and 170 million in 2030. Under the huge market demand for hypoglycemic drugs, the market size of my country's GLP-1 drugs for the treatment of type 2 diabetes is expected to reach 15.9 billion yuan in 2026. The number of obese people in my country continues to increase, and it is expected that the number of obese people in my country will reach 329 million by 2030. GLP-1 drugs have shown significant efficacy in weight loss. It is estimated that China's GLP-1 drug market size for treating obesity will reach 12.2 billion yuan in 2026. In addition, the number of patients with potential drug use for diabetes risk factors is expected to reach 69 million to 98 million, and the number of patients with diabetes complicated by cardiovascular disease is expected to reach 60 million. GLP-1 drugs have shown potential therapeutic prospects.

Currently, domestic GLP-1 drug research and development is in full swing. For liraglutide alone, more than ten domestic pharmaceutical companies have made relevant arrangements. Liraglutide’s compound patent in China expired in 2017, leading to a wave of research and development of liraglutide generic drugs in the domestic market. According to public data, as of December 2024, domestic liraglutide companies such as Tonghua Dongbao, China Biopharmaceuticals, and Huadong Medicine have been approved for marketing. In addition, generic drugs of liraglutide from Chen'an Biological, United Laboratories and Hanyu Pharmaceutical are in the marketing application stage.

Huadong Medicine Liraglutide: In March 2023, Huadong Medicine's subsidiary Hangzhou Zhongmei Huadong announced that it had received the "Drug Registration Certificate" issued by the State Food and Drug Administration and approved Liraglutide Injection (trade name: Lilupine) For the treatment of blood sugar control in adults with type 2 diabetes. In July 2023, this product was officially approved for marketing in China for obesity or overweight indications. Huadong Medicine is also actively exploring overseas markets for liraglutide. In June 2022, Huadong Medicine signed a strategic cooperation agreement with Julphar, one of the largest pharmaceutical manufacturers in the Middle East and Africa, granting the latter two indications of liraglutide injection product diabetes and weight loss in the United Arab Emirates, Saudi Arabia, Egypt, etc. Development, production and commercialization interests in 17 countries in the Middle East and North Africa region.

Tonghua Dongbao Liraglutide: In December 2023, the marketing application of Tonghua Dongbao Liraglutide Injection was approved by China’s National Medical Products Administration (NMPA) for the treatment of type 2 diabetes. This product became the first drug after Huadong Medicine to The second domestically produced liraglutide on the market.

Chia Tai Tianqing Liraglutide: In June 2024, NMPA approved the marketing application of Chia Tai Tianqing’s liraglutide injection biosimilar. The company's liraglutide injection can rely on glucose to activate endogenous insulin secretion, reduce glucagon secretion, slow gastric motility and emptying, reduce appetite and food intake, while avoiding hypoglycemia and weight gain. Control blood sugar.

Although longer-acting GLP-1 receptor agonists such as semaglutide and tilpotide have occupied a large market space in advance, the global market space of nearly US$6 billion still belongs to liraglutide. The production capacity and supply of GLP-1 drugs in the United States is seriously insufficient, especially GLP-1 weight-loss drugs, and liraglutide is still on the U.S. Shortage Drug List. The launch of Hanyu Pharmaceutical's liraglutide generic drug in the United States will provide more To provide more help to patients in need, domestically produced liraglutide is about to be released in the United States.

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