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 expansion of China's liraglutide generics.

Estimated peak sales of $135 million
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 increase satiety, thereby reducing blood sugar and body weight. Liraglutide was originally developed by Novo Nordisk and launched in the European Union in 2009, followed by Japan and the United States in 2010, and entered the Chinese market in 2011. It was approved for use in adult patients with type 2 diabetes to control blood sugar (trade name: Novo). In recent years, in addition to diabetes, the research areas of liraglutide have also involved obesity, nervous system diseases, and cardiovascular system diseases. In December 2014, liraglutide was approved by the US FDA for weight loss.

Hanyu Pharmaceutical's liraglutide injection formally submitted an ANDA application in September 2021. In June 2024, the product obtained tentative approval from the US FDA. In October 2024, liraglutide injection ushered in large-scale shipments. This order was a RMB 103 million preparation purchase order from Hikma announced by the company in 2023. This liraglutide injection adopts an external licensing cooperation model, and Hanyu Pharmaceutical has obtained a double-digit sales profit share. In addition to this order, Hanyu Pharmaceutical has successively received three purchase orders from Hikma in 2024, with amounts of RMB 72 million, RMB 84 million, and RMB 77 million respectively. In November 2024, Hanyu Pharmaceutical's zero-defect API production base passed the US FDA on-site inspection again. So far, Hanyu Pharmaceutical has successfully passed the US FDA's cGMP standard on-site inspection for both API production bases and preparation production bases, and has continuously received multiple GLP-1 API and preparation overseas commercial batch orders. In addition to the formal approval from the FDA, Hanyu Pharmaceutical said that it had submitted an application for marketing approval of liraglutide injection in China in October 2024 and was accepted; in addition, Southeast Asia, South America, the Middle East and other places will gradually enter the application process.

According to Novo Nordisk's annual report, affected by the tilt of semaglutide production capacity, the sales of liraglutide (Victoza, the glucose-lowering version, and Saxenda, the weight-loss version) in the United States from 2021 to 2023 will be approximately US$1.62 billion, US$1.51 billion, and US$970 million, respectively. Founder Securities said that as the first generic liraglutide drug 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 the peak sales of Hanyu Pharmaceutical's liraglutide generic drugs in the United States are expected to reach US$135 million.

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

Global scale is nearly US$6 billion
According to public data, the global liraglutide terminal market size will be US$5.991 billion in 2023, of which the US terminal market size is approximately US$3.204 billion and the Chinese terminal market size is approximately US$197 million. Liraglutide has shown great commercial potential in the North American market. People in North America have a high awareness of the treatment of diabetes and obesity, and healthcare spending is relatively sufficient. Coupled with the large number of obese people, the demand for the liraglutide market has been driven. It is expected that the market size will continue to grow from 2024 to 2030.

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

China is about to increase its volume
in China 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, China's GLP-1 drug market size for the treatment of type 2 diabetes is expected to reach 15.9 billion yuan in 2026. The number of obese people in China continues to increase, and it is expected that the number of obese people in China 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.

At present, the development of GLP-1 drugs in China is in full swing. For liraglutide alone , more than ten pharmaceutical companies in China have made relevant arrangements. The compound patent of liraglutide in China expired in 2017, leading to a wave of liraglutide generic drug development in the Chinese market. According to public data, as of December 2024, Tonghua Dongbao, China Biopharmaceuticals, Huadong Medicine and other companies have been approved for listing of liraglutide in China . In addition, liraglutide generic drugs from Chenan Bio, United Pharmaceutical and Hanyu Pharmaceutical are in the listing application stage.

Huadong Medicine's Liraglutide: In March 2023, Hangzhou Sino-US Huadong, a subsidiary of Huadong Medicine, announced that it had received the "Drug Registration Certificate" issued by the National Medical Products Administration, approving liraglutide injection (trade name: Liluping) for the treatment of blood sugar control in adults with type 2 diabetes. In July 2023, the product's obesity or overweight indications were officially approved for marketing in China. 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 companies in the Middle East and Africa, granting the latter the development, production and commercialization rights of liraglutide injection products for two indications of diabetes and weight loss in 17 countries in the Middle East and North Africa, including the UAE, Saudi Arabia, and Egypt.

Tonghua Dongbao Liraglutide: In December 2023, Tonghua Dongbao's liraglutide injection's application for marketing approval was approved by the China National Medical Products Administration (NMPA) for the treatment of type 2 diabetes. This product became the second Chinese liraglutide to be launched after Huadong Medicine.

Zhengda Tianqing Liraglutide: In June 2024, NMPA approved Zhengda Tianqing's liraglutide injection biosimilar application for marketing. The company's liraglutide injection can activate endogenous insulin secretion based on glucose, reduce glucagon secretion, slow gastric motility and emptying, reduce appetite and food intake, and control blood sugar while avoiding hypoglycemia and weight gain.

Although longer-acting GLP-1 receptor agonists such as semaglutide and telportide have already occupied a large market space in advance, the global market space of nearly $6 billion still belongs to liraglutide. In the United States, the production capacity and supply of GLP-1 drugs are seriously insufficient, especially GLP-1 weight loss drugs, and liraglutide is still on the US list of drugs in short supply. The launch of Hanyu Pharmaceutical's liraglutide generic drugs in the United States will provide more help to more patients in need, and China's liraglutide will soon be released in the United States.

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