Qilu Pharma Submits ANDA for Dapagliflozin/Metformin Extended-Release Tablets, Challenging AstraZeneca's First-to-Market Position

Dec 11, 2023 13:02 CST Updated 13:02

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

AstraZeneca

Pharmaceutical Technology Research and Development Provider

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 hydrochloride sustained-release tablets submitted by Qilu Pharmaceutical has been accepted for review by the CDE, and it is expected to compete for the first generic approval of this drug.

The original research company of Dapagliflozin Metformin Sustained-Release Tablets 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 combination drug for the treatment of type 2 diabetes.It is currently the only compound oral formulation in China that requires only once-daily oral administration with a fixed dose of an SGLT2 inhibitor and extended-release metformin hydrochloride.。The two glucose-lowering components, metformin and SGLT2 inhibitors, have complementary mechanisms of action.Can achieve stronger and longer-lasting blood glucose control, and the sustained-release formulation can reduce the number of medications patients need to take.Further improve blood glucose management outcomes. Additionally, this drugCan also protect heart and kidney health while achieving good blood glucose control., making the therapeutic effect more comprehensive.

Data from Zhongkang Kaisi shows,Sales of Oral Hypoglycemic Drugs in Chinese Hospitals and Retail Markets Reach 27.88 Billion Yuan in 2022，A new type of oral hypoglycemic compound preparation has officially landed in the Chinese market, making the competition in China's hypoglycemic drug market increasingly fierce.

The Number of Diabetes Patients Continues to Rise

The Market Size of Oral Hypoglycemic Drugs is Expanding Rapidly

According to the International Diabetes Federation (IDF) data, 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 important 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.CurrentlyOral hypoglycemic agents are roughly divided into biguanides, α-glucosidase inhibitors, thiazolidinediones, SGLT2 inhibitors, sulfonylureas, glinides, DPP-4 inhibitors, and GLP-1 receptor agonists, etc.

According to data from CKDM-Expanse,In the first three quarters of 2023, the market size of oral hypoglycemic drugs in tertiary hospitals reached 12.852 billion yuan. There were three drugs with sales exceeding 1 billion yuan. The top-ranked drug was dapagliflozin, with sales reaching 2.451 billion yuan.

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

Source: CKDMed System, CIC Industry Research Institute

In the retail market,The market size of oral hypoglycemic drugs in the first three quarters of 2023 was 8.728 billion yuan, with two drugs having sales exceeding 1 billion yuan. The top-selling drug was metformin, with sales surpassing 2.2 billion yuan.

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

Source: CKDMT System, CIC Industry Research Institute

Compound Oral Hypoglycemic Agents: A New Frontier in Diabetes Treatment

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

In recent years,In China, the diabetes treatment market is witnessing a surge of innovative combination drugs, with multiple companies shifting their focus to the development of combination therapy products in pursuit of superior clinical outcomes.Since metformin is the first-line medication for controlling hyperglycemia in patients with type 2 diabetes and a fundamental component in combination therapies, it will continue to be included in the patient's treatment regimen in the absence of contraindications. As a foundational drug, compound oral formulations are typically composed of "metformin + other oral hypoglycemic agents."

Some domestically researched compound hypoglycemic agents in China

Source: Public information, organized by Sino Health Industry Research Institute

The Zhongkang Kaisi system shows that the overall market size of compound preparations of biguanides and other oral hypoglycemic agents is increasing year by year.In the first three quarters of 2023, the sales revenue of compound formulations of biguanides and other oral hypoglycemic agents in tertiary hospitals exceeded 2 billion yuan, a year-on-year increase of 31.2%, while the sales revenue in the retail market was 713 million yuan.。

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

Source: CKDMed System, CIC Industry Research Institute

Notably, on November 13 this year, Hengrui announced that its subsidiary, Shengdi Pharmaceutical, had submitted a new drug marketing application for the compound hypoglycemic oral preparation HR20031 tablets, which has been accepted.Currently, most oral compound hypoglycemic drugs are composed of two types of hypoglycemic medications. However, Hengrui's HR20031 tablet is composed of three components, one of which is metformin, while the other two, Hengliptin and Repaglinide, were both developed by Hengrui.Henggeleijing is an SGLT2 inhibitor, which was approved for marketing by the NMPA in December 2021. It reduces renal tubular glucose reabsorption and increases urinary glucose excretion. Regleletin is a DPP-4 inhibitor, approved for marketing by the NMPA in June 2023. It enhances GLP-1 levels, promotes insulin secretion, and inhibits glucagon secretion to exert its hypoglycemic effect.HR20031 Tablets Lower Blood Sugar Through Three Different MechanismsAt the same time, this drug is also a sustained-release formulation, designed to be taken orally once a day, which can reduce the frequency of medication, simplify the treatment regimen, and is expected to improve patient compliance with the treatment.。

Conclusion

Under the Trend of Increasing Global Diabetes Patients, the Field of Diabetes Treatment is Welcoming Innovation. Combination Therapy has Become a Key Method for Blood Sugar Control in Diabetic Patients, and the Market Size of Compound Oral Hypoglycemic Drugs is Rising Year by Year. Compound Preparations Lower Blood Sugar Through Different Mechanisms, Offering Patients More Innovative and Effective Treatment Options, Meeting the Needs of Different Patient Groups, Promoting Diabetes Treatment Towards a More Personalized and Comprehensive Direction, and Providing New Hope for Future Diabetes Treatment.

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