Recently,According toThe CDE official website shows,Qilu PharmaceuticalSubmittedCategory 4 Generic Chemical DrugsDapagliflozin Metformin Sustained-Release Tablets (Ⅰ)/ (Ⅲ)Listing application approvedCDE Acceptance.According to the data from PharmaCloud, the peak sales of diabetes medications in China's hospital market exceeded 30 billion yuan.Currently, there is no such thing in China.Dapagliflozin Metformin Sustained-Release TabletsGeneric Drug Approved.This YearOn November 10, Qilu Pharmaceutical's first oral hypoglycemic agent, QLR12018, received implied permission for clinical trials.Qilu PharmaceuticalAnother Heavyweight Compound Antidiabetic Drug Layout: Competing with Chia Tai Tian Ching, Beijing Fuyuan Pharmaceutical,Jiangsu Xuantai Pharmaceuticaletc.Five Companies in Fierce Competition, Aggressively Pursuing the First Generic.

 Screenshot source:CDE Official Website

Dapagliflozin Metformin Sustained-Release TabletsThe original product is developed byAstraZenecaDevelopment: Dapagliflozin Metformin Sustained-Release Tablets combine two antihyperglycemic drugs with complementary mechanisms of action: dapagliflozin.(Product name: Andatang), a sodium-glucose cotransporter-2（SGLT2）Xigduo XR, an SGLT2 inhibitor, was approved by the FDA on October 30, 2014. Xigduo XR is the first once-daily oral combination medication of an SGLT2 inhibitor and extended-release metformin hydrochloride to be approved in the United States. Xigduo XR can be used as an adjunct to diet and exercise, improving glycemic control in adult patients with type 2 diabetes when dapagliflozin and metformin are used together.

In recent years, the threat of diabetes to human health has been increasing, and the sharp rise in the number of patients undoubtedly imposes a heavy burden on human health and social development. According to the International Diabetes Federation（IDF）It is estimated that by 2030, nearly 500 million people worldwide will suffer from diabetes. According to the PharmaCloud database, the in-hospital sales of diabetes chemical drugs/biologics in China increased from 20 billion yuan in 2014 to 34 billion yuan in 2022, with an annual compound growth rate of 7.0%.

Screenshot source: PharmaCloud China Hospital Sales Database

The competition in the hypoglycemic drug market in China is becoming increasingly fierce.Qilu Pharmaceutical, Nanjing Chia Tai Tian Qing, Beijing Fuyuan PharmaceuticalAndZhejiang Huahai PharmaceuticalWell-known pharmaceutical companies such as Qilu Pharmaceutical Co., Ltd. have joined the fray.This YearFebruary,Nanjing Zhengda TianqingFirst to Report ProductionDapagliflozin Metformin Sustained-Release Tablets, subsequentlyBeijing Fuyuan MedicineAlso reported consecutively on October 13Dapagliflozin Metformin Sustained-Release Tablets(Ⅰ) / (Ⅲ)。In addition,Zhejiang Huahai PharmaceuticalTheDapagliflozin Metformin Sustained-Release Tablets (Ⅰ) 、Dapagliflozin Metformin Sustained-Release Tablets (Ⅲ)、Dapagliflozin Metformin Sustained-Release Tablets (IV)Also on November 8 this year, it was accepted by the CDE for the same type of generic drug production.Qilu Pharmaceutical also rose to the challenge. On November 10 this year, Qilu Pharmaceutical's first oral hypoglycemic agent, a Class 1 new drug named QLR12018, received tacit approval for clinical trials.This timeQilu PharmaceuticalAnother Major Compound Antidiabetic Drug in the Pipeline.According to the statistics from Pharma Intelligence, currently, there are no such products available in China.Dapagliflozin Metformin Sustained-Release TabletsGeneric Drug Approval: Qilu Pharmaceutical Competes with Zhengdatianqing, Beijing Fuyuan Pharmaceutical, and Jiangsu Xuantai Pharmaceutical in a Battle for the First Generic.

Screenshot source: PharmaOcean China Drug Evaluation

Diabetes Medications in 2022(Chemical or Biologic Drug)In the Chinese hospital sales market, the top 10 products all have sales exceeding 1 billion yuan, among whichDagliflozin Tablets, Insulin Aspart 30 InjectionAndInsulin Glargine InjectionIs a super 2.4 billion-level large variety. Among themSemaglutide InjectionRapidly reversing, it has entered the top ten list for the first time. Currently, this product has only one production approval, held by Novo Nordisk.

Screenshot source:PharmCube China Pharmaceutical Sales Database - Comprehensive Analysis

According to the statistics from Pharma Intelligence, since the beginning of this year, diabetes medications(Chemical or Biopharmaceutical)Already have 60 varieties(161 specifications)Approved for Marketing; 37 Varieties of Diabetes Generic Drugs(231 specifications)Submitted generic applications, all currently under review and approval, with fierce market competition.

In addition,2023 to PresentQilu PharmaceuticalThere isOne Class 1 new drug submitted for IND approval and received clinical authorization., withCanagliflozin Tablets, Sitagliptin Metformin Tablets (Ⅱ)Two varieties passed the evaluation.Except for this submissionDapagliflozin Metformin Sustained-Release Tablets (Ⅰ) / (Ⅲ)，Submitted as of 2023Empagliflozin and Linagliptin Tablets, Empagliflozin Tablets, Dapagliflozin Tabletsetc.Six generic applications for diabetes varieties are all under review.

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