Qilu Pharma Submits ANDA for Dapagliflozin/Metformin Extended-Release Tablets as Oral Antidiabetic Market Expands

Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the marketing application for the generic version of Dapagliflozin Metformin Sustained-Release Tablets submitted by Qilu Pharmaceutical Co., Ltd. has been accepted by the CDE, and it is expected to compete for the first generic approval of this drug.

 

 

The original research of Dapagliflozin Metformin Sustained-Release TabletsEnterpriseIt is AstraZeneca. On November 22 this year, the launch meeting and satellite symposium for this original drug (brand name: Andas) were successfully held at the 2023 Chinese Medical Association Diabetes Branch Conference. Andas is a compound formulation for the treatment of type 2 diabetes. It is currently the only fixed-dose compound oral formulation in China that requires only one oral administration per day, combining an SGLT2 inhibitor with extended-release metformin hydrochloride. The two glucose-lowering components, metformin and the SGLT2 inhibitor, have complementary mechanisms of action, enabling more potent and sustained blood glucose control. Additionally, the extended-release formulation reduces the number of medications patients need to take, further enhancing blood glucose management. Moreover, this medication can achieve good glycemic control while also providing protection.HeartAnd KidneysHealth, making the therapeutic effect more comprehensive.

 

Data from Zhongkang Kaosi shows that, in 2022, oral hypoglycemic drugs in China...HospitalWith retail market sales reaching 27.88 billion yuan, another new oral hypoglycemic combination drug has officially entered the Chinese market, intensifying competition in China's hypoglycemic drug market.

 

　　01、The Number of Diabetes Patients Continues to Rise Oral Hypoglycemic Drug Market Size Expands Rapidly

 

According to data from the International Diabetes Federation (IDF), in 2021, there were 537 million adults aged 20 to 79 with diabetes worldwide, and this number is expected to increase to 783 million by 2045. China has the largest number of diabetes patients globally, with the number increasing from 90 million in 2011 to 141 million in 2021, a rise of 56%. Diabetes has become one of the significant public health issues in China. Diabetes is divided into Type 1 and Type 2, with Type 2 being more common.

 

In the process of addressing this challenge, effective treatment methods are crucial. Currently, oral hypoglycemic agents are roughly divided into biguanides, α-glucosidase inhibitors, thiazolidinediones, SGLT2 inhibitors, sulfonylureas, glinides, DPP-4 inhibitors, and GLP-1 receptor agonists, among others.

 

Data from Zhongkang Kaosi shows that in the first three quarters of 2023, the market size of oral hypoglycemic drugs in graded hospitals reached 12.852 billion yuan. There were three drugs with sales exceeding 1 billion yuan, ranking first was Dapagliflozin, with sales reaching 2.451 billion yuan.

 

Top 10 Oral Antidiabetic Drug Sales in Chinese Tiered Hospitals, Q1-Q3 2023

 

In the retail market, the market size of oral hypoglycemic drugs in the first three quarters of 2023 was 8.728 billion yuan. Two drugs had sales exceeding 1 billion yuan, with metformin ranking first in sales, surpassing 2.2 billion yuan.

 

Top 10 Oral Hypoglycemic Drug Sales in China's Retail Market Q1-Q3 2023

 

　　02、Compound Oral Hypoglycemic Agents: A New Frontier in Diabetes Treatment

 

The UK Prospective Diabetes Study found that three years after the initial treatment of diabetes patients, about 50% require combination therapy to achieve blood glucose control targets. This figure increases to 75% after nine years of treatment, especially for newly diagnosed patients with high blood sugar levels, who usually need combination therapy. Therefore, combination therapy has become an indispensable key method for diabetic patients to control their blood sugar, and the development of compound drugs has provided more options for treatment.

 

In recent years, the diabetes treatment market in China has seen a surge in innovative combination drugs. Multiple companies have shifted their focus to the development of combination therapy products in pursuit of better clinical outcomes. As metformin is the first-line medication for controlling hyperglycemia in patients with type 2 diabetes and serves as a fundamental drug in combination therapies, it remains a consistent part of the treatment regimen for these patients unless contraindicated. As a foundational drug, combination oral formulations are typically composed of "metformin + other oral hypoglycemic agents."

 

Some domestically researched compound hypoglycemic agents in China

 

Data shows that the overall market size of compound formulations of biguanides and other oral hypoglycemic drugs is increasing year by year. In the first three quarters of 2023, the sales of compound formulations of biguanides and other oral hypoglycemic drugs in hospitals exceeded 2 billion yuan, a year-on-year increase of 31.2%, while the sales in the retail market were 713 million yuan.

 

2017-2023 (Q1-Q3) Sales Situation of Biguanides and Other Oral Antidiabetic Drugs Compound Preparations in China

 

It is worth mentioning that on November 13 this year, Hengrui announced that its subsidiary, ShengdiPharmaceuticalsNew Drug Application for HR20031 Tablets, a Compound Oral Hypoglycemic Agent, Submitted and Accepted. Currently, most oral compound hypoglycemic drugs are composed of two types of hypoglycemic medications. However, Hengrui's HR20031 tablets consist of three components: one is metformin, and the other two, developed by Hengrui, are sodium-glucose co-transporter 2 (SGLT2) inhibitor Henglijiang and DPP-4 inhibitor Reeglitan. Henglijiang, an SGLT2 inhibitor, was approved for marketing by the NMPA in December 2021. It lowers blood sugar by reducing glucose reabsorption in renal tubules and increasing urinary glucose excretion. Reeglitan, a DPP-4 inhibitor, received NMPA approval in June 2023. It works by increasing GLP-1 levels to promote insulin secretion and inhibit glucagon secretion, thereby exerting its hypoglycemic effect. HR20031 tablets lower blood glucose through three distinct mechanisms. Additionally, this drug is a sustained-release formulation designed for once-daily oral administration, which reduces dosing frequency, simplifies treatment regimens, and is expected to improve patient adherence to therapy.

 

　　03、Conclusion

 

Under the trend of a continuously increasing number of diabetes patients worldwide, the field of diabetes treatment is witnessing innovation. Combination therapy has become a key method for blood sugar control in diabetes patients, and the market size for compound oral hypoglycemic drugs is rising year by year. Compound preparations lower blood sugar through different mechanisms, providing patients with more innovative and effective treatment options that meet the needs of different patient groups. This pushes diabetes treatment towards a more personalized and comprehensive direction, offering new hope for the future of diabetes care.