According to the announcement on the CDE official website, recentlyChengdu Hengrui Pharmaceutical Co.,Ltd.Submitted Category 4 Generic Chemical DrugEmpagliflozin TabletsThe listing application has been accepted.

Screenshot source: CDE official website

In the field of diabetes medications, in addition to the recently reported production of Empagliflozin Tablets, Hengrui Pharmaceutical also hasAcarbose TabletsAndVildagliptin TabletsTwo generic drugs are under review for production.According to the PharmaCloud database, Hengrui Pharmaceutical currently has 10 active approvals for diabetes medications, involving 7 different types.

So far, Hengrui Pharmaceutical has a total of at least 16 new diabetes drugs, of which 2 have been launched.(SGLT2 inhibitor Hengrui Steglatro andDPP-4 InhibitorRimeglibin Phosphate Tablets），Class 1 New DrugHengruiGlyburide Metformin Tablets (Ⅰ)/(Ⅱ)Currently under review for market approval, there are two Class 2 new drugs in the application stage for market launch, respectively.Proline Hengrui Pharmaceutical Tablets(2.4 Category)AndHengrui Pharmaceutical's Hengli Jing + Metformin Compound Preparation(2.3 Category)In addition, more than 10 new drugs have entered the clinical stage.

Empagliflozin isBoehringer IngelheimAndEli LillyThe collaborative project involves an oral, once-daily, highly selective sodium-glucose cotransporter 2（SGLT2）Inhibitor. It can both prevent the reabsorption of sugar by the kidneys through SGLT2 inhibition and block salt reabsorption, increasing salt excretion in the body. In 2022, the global revenue of empagliflozin reached 8.2 billion US dollars.

In China, the hospital sales revenue of Empagliflozin Tablets in 2022 was 3.48 billion yuan, increasing by 42% year-on-year, and it still maintained a stable growth trend in 2023.

Screenshot source: PharmaCloud China Hospital Sales Database

On August 17, 2020, the China National Intellectual Property Administration issued the "Decision on the Review of the Invalidity Declaration Request" for empagliflozin, ruling its compound patent invalid. As a result, many domestic generic drug companies have entered the market. Currently, there areHausen(First to pass the review), Kelun Pharmaceutical, Zhengdatianqing, Wanbang Pharmaceutical, AosaikangEleven local pharmaceutical companies, including Hengrui Pharmaceutical, have received approval for Empagliflozin Tablets and passed the consistency evaluation.AnotherGanli Pharmaceutical, Jiudian Pharmaceutical, Zhejiang Nuode Pharmaceutical, Sinopharm GroupSeveral pharmaceutical companies, including Hengrui Pharmaceutical, have submitted generic drug applications for Empagliflozin Tablets, all of which are currently under review and approval.

In addition, in the field of diabetes medications, apart from the recently reported production of Empagliflozin Tablets, Hengrui Pharmaceutical also has...Acarbose TabletsAndVildagliptin TabletsTwo generic drugs are under review for production.

China is a "diabetes大国", with over 140 million people suffering from diabetes, of which approximately 72.83 million cases have not yet been diagnosed. As diabetes requires lifelong medication, the market for treatment drugs has an enormous demand.According to the PharmaCloud database, the in-hospital sales revenue of diabetes chemical drugs/biologics in China increased from 20 billion yuan in 2014 to 34.3 billion yuan in 2021, with an annual compound growth rate of 7.99%.

Screenshot source: PharmaCloud China Pharmaceutical Sales Database

From the perspective of enterprises, the domestic market in the diabetes drug field is currently still dominated byNovo Nordisk, Sanofi, AstraZenecaOccupied by multinational pharmaceutical companies, while local pharmaceutical companies focus onHangzhou Zhongmei Huadong Pharmaceutical,Ganli Pharmaceutical, Tonghua DongbaoTaking the lead. Hengrui Pharmaceutical is making a strong push into the diabetes field, striving to secure a significant position. It can be said that the company has now taken its first step in the commercialization of new diabetes drugs.

Hengrui's Currently Marketed Diabetes Medications

Data Source: PharmaCloud China Drug Approval Database

According to the PharmaCloud database, Hengrui Pharmaceutical currently has 10 active approvals related to diabetes medications in use, involving 7 different types, of whichPhosphate Reglitinib Tablets, Proline Hengrulinib TabletsAndRosiglitazone TabletsExclusive variety.

It is worth mentioning that Renglitinib and Henglitinib are Class I new drugs independently developed by Hengrui Pharmaceutical. According to the Hengrui official website, a Phase III clinical trial for the treatment of type 2 diabetes using Renglitinib + Henglitinib + Metformin is currently underway.

Hengrui Pharmaceutical has innovative drugs in multiple therapeutic areas, with a particularly broad layout in diabetes that is already showing initial results. Currently, there are two new diabetes drugs on the market.(SGLT2 inhibitor Hengrui Steglatro andDPP-4 InhibitorRimegline Phosphate Tablets）, Class 1 New DrugHengruiGlyburide Metformin Tablets (Ⅰ)/(Ⅱ)Currently under review for market approval, there are two Class 2 new drugs in the application phase for market entry, respectively.Proline Hengrui Pharmaceutical Tablets(2.4 Category)AndHengrui Pharmaceutical's Hengliujing + Metformin Compound Preparation(2.3 Category)In addition, more than 10 new drugs have entered the clinical stage.

Data Source: PharmaCloud Database, Corporate Official Website

In the biologics field, Hengrui Pharmaceutical has developed long-acting insulin.INS068、GLP-1 AnaloguesNoliglapeptide; Ultra-fast-acting insulinHR011408Has also entered Phase I clinical trials; in the current hot research direction of GLP-1/GIP dual-target agonists in the hypoglycemic field, Hengrui Pharmaceutical has similarly made a strategic layout.

In fact, in recent years, pharmaceutical companies in China have shown great enthusiasm in the research and development of diabetes drugs. Currently, several new drugs have entered Phase III clinical trials, and there are...Shiyao GroupTheDBPR108、SalubrisTheFugluretin、Four Rings PharmaceuticalsGaglinet Tablets、SystexTheSeng列汀、Novo Nordisk'sSemaglutide TabletsAwaiting submission of the marketing application in China,Worth paying attention to.

Whether it is insulin or non-insulin drugs, they are expected to be launched soon, providing more options for patients with diabetes.

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