China's first liraglutide-like drug is here. The original drug sells more than 12 billion yuan globally a year
On the evening of March 30, Huadong Pharmaceutical announced that its wholly-owned subsidiary Hangzhou Sino-American Huadong received the "Drug Registration Certificate" approved and issued by the State Food and Drug Administration. Liraglutide Injection (trade name: Rilupine) marketing authorization application was approved for use in adult patients with type 2 diabetes to control blood sugar.
As a popular drug in the development of non-insulin antidiabetic drugs, the global market size of GLP-1 receptor agonists has reached tens of billions of dollars, attracting many multinational and local companies. As for liraglutide injection, only Huadong Medicine and the original research company's liraglutide injection have been approved for diabetes indications in China. Huadong Medicine is also the first domestic company to submit liraglutide injection for obesity or overweight indications. Manufacturers applying for listing.
Global sales of original research diabetes drug exceed 12 billion yuan
Liraglutide is a GLP-1 (glucagon-like peptide 1) receptor agonist. GLP-1 products are relatively safe and have the effects of weight loss, hypoglycemic and cardiovascular benefits. They are relatively mature, stable and safe. The target is mainly used in clinical practice to improve blood sugar control in adults with type 2 diabetes, and has been included in many diabetes documents such as the "National Guidelines for the Prevention and Treatment of Diabetes at the Primary Level (2022)", "China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)" Prevention and Control Guide.
As a classic GLP-1-targeting drug, liraglutide injection has maintained rapid growth in sales in both domestic and foreign markets. According to the 2022 financial report data of the original pharmaceutical company Novo Nordisk, the global sales of Victoza (liraglutide diabetes indication product) in 2022 will be 12.328 billion yuan, and the Chinese market sales will be approximately 1.479 billion yuan.
Huadong Medicine's liraglutide injection is a biosimilar of the original drug and adopts a different production process from Novo Nordisk. In June 2021, Huadong Medicine completed the clinical research work of liraru (diabetic indication), submitted a marketing application to the State Food and Drug Administration in August 2021, and was accepted in September of that year.
As a new type of anti-diabetic drug that has been launched in recent years, GLP-1 receptor agonists not only lower blood sugar, but also have the effects of weight loss, lowering blood pressure, and protecting cardiovascular and kidneys. Liraglutide and semaglutide have been approved for the treatment of obesity abroad and are both products of Novo Nordisk. Among them, the original drug liraglutide was approved for weight loss indications in December 2014, and was the first GLP-1 analog approved for weight loss. As of now, the weight loss indication of the original drug has not yet been declared for marketing in China.
Huadong Medicine's liraglutide injection is not only the first domestic drug approved for diabetes indications, but is also expected to be the first to be approved for weight loss indications. On July 13, 2022, Huadong Medicine announced that the marketing authorization application for liraglutide injection for obesity or overweight indications has been accepted. It is the first domestic company to submit a registration application and is expected to come out on top.
20 domestic GLP-1 target innovative drugs are under development
GLP-1 is one of the three popular targets for the development of non-insulin antidiabetic drugs. Global diabetes drug giants such as Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, GlaxoSmithKline, etc. are targeting this One or more innovative drugs have been targeted, and several GLP-1 receptor agonists such as semaglutide, liraglutide, dulaglutide, and exenatide have been launched, forming a tens-billion-dollar market. Sales scale, these drugs compete differentiatedly in terms of hypoglycemic, weight loss, cardiovascular benefits, patient compliance, effectiveness and safety.
In 2022, the GLP-1 market will surpass insulin and become the largest driver of the diabetes market. Taking Novo Nordisk as an example, its GLP-1 receptor agonist revenue exceeded insulin in 2022, with sales reaching US$10.94 billion, a year-on-year increase of 56%; its sales in China were approximately 3.7 billion yuan, a year-on-year increase of 88%.
The huge market has attracted the deployment of many domestic companies, including Huadong Pharmaceutical. In China, there are also Innovent Biologics, CSPC Pharmaceutical Group, I-Mab Biotech, Hengrui Pharmaceuticals, Ganli Pharmaceuticals, Hansoh Pharmaceuticals, Dongguang Biotech, etc. who are developing GLP- 1 receptor agonists, in addition to biosimilar drugs, there are 20 GLP-1 target innovative drugs for type 2 diabetes under development.
Huadong Medicine is one of the earliest pharmaceutical companies in China to deploy GLP-1 targets. It has built a comprehensive and differentiated product pipeline that combines long-acting and multi-target global innovative drugs and biosimilars, including oral and injectable drugs. . In addition to the liraglutide biosimilar approved for marketing this time, the R&D pipeline also includes the GLP-1 receptor agonist HDM1002, TTP273 (oral small molecule GLP-1 receptor agonist), GLP-1R/GCGR/ There are many drugs under development including DR10624, a multiple agonist of FGF21R target, and semaglutide injection (biosimilar drug).
In the field of diabetes, Huadong Medicine has completed the overall layout of innovative targets and differentiated generic drugs. The existing and subsequent upgraded products include -glycosidase inhibitors, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 receptor body agonists, as well as GLP-1 receptor and GIP receptor dual agonists, insulin and its analogs and many other mainstream clinical targets. Huadong Medicine stated that in the future, it will still regard diabetes medication as an important core area, continue to expand its layout, continue to promote the research and development and industrialization process of new drugs under research and introduction, and actively promote the international business process, gradually transforming from a domestic leader to a global leader in diabetes. Pharmaceutical companies are developing rapidly.
GZR18, a GLP-1 receptor agonist weekly preparation independently developed by Ganli Pharmaceuticals, is also undergoing clinical trials for indications of type 2 diabetes, obesity and overweight weight management. Nuotech's new, long-acting GLP-1 peptide analogue SPN0103-009 injection was approved for clinical trials in July last year. It is intended to be used to treat type 2 diabetes and obesity, and will eventually be expanded to non-alcoholic medicines for which there are no drugs. Fatty Liver Disease and Alzheimer's Disease.
Since GLP-1 receptor agonist drugs are still in their infancy in China, their market share lags significantly behind other regions around the world. Statistics from CICC Enterprises show that China's GLP-1 receptor agonist drug market will expand at a compound annual growth rate of up to 57%, reaching 15.6 billion yuan in 2025. As GLP-1 receptor agonists are gradually included in the national medical insurance catalog, the average annual treatment cost has dropped significantly, and its penetration rate will further increase.
