Qilu Pharmaceutical's First Oral Antidiabetic New Drug QLR12018 Enters Clinical Stage; 11 Antidiabetic Drugs Targeting a 30-Billion-Yuan Market
Qilu Pharmaceutical
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Recently,The CDE official website shows,Qilu PharmaceuticalDeclaredClass 1 New DrugQLR12018 TabletsReceived implied permission for clinical trials, this is Qilu Pharmaceutical's first orally-administered hypoglycemic new drug approved for clinical use. According to PharmaCloud data statistics, the current market for diabetes has reached over 30 billion.
Screenshot source: PharmaOcean China Drug Evaluation
QLR12018 TabletsProduced byQilu PharmaceuticalThe Class 1 innovative drug developed by Qilu Pharmaceutical Co., Ltd. submitted its clinical application on August 29, 2023, and it was accepted. Recently, it has received tacit approval for clinical trials to be used alone or in combination with metformin oral hypoglycemic drugs for type 2 diabetes with inadequate efficacy.(T2DM)Blood Glucose Control in Patients.
11 Hypoglycemic DrugsApproved，Aggressively Targeting the 30 Billion Market
According to the International Diabetes Federation（IDF）According to the survey data, China has become the world's largest diabetes country. In 2021, the number of people aged 20-79 with diabetes reached 141 million, with a prevalence rate as high as 10.6%, and this figure shows an increasing trend year by year. Although diabetes itself does not directly cause death, its severe complications can be fatal. Among them, diabetic peripheral neuropathy（DPN）Is one of the most common chronic complications in patients with diabetes. The occurrence of this complication is closely related to factors such as the duration of diabetes and blood glucose control. The main symptoms of DPN include numbness and pain in the hands and feet. In severe cases, it may lead to limb ulcers or even necessitate amputation, causing significant physical and mental harm to patients.
At present, the treatment of diabetic peripheral neuropathy mainly relies on drugs, and the drug market has great potential.According to the PharmaCloud database, China's diabetes chemical drugs/Biopharmaceuticals in-hospital sales revenue in China from 2014Year20Increased from 0 billion yuan to 34 billion yuan in 2022, with a compound annual growth rate of 7.0%.
Screenshot source: Pharma Intelligence China Pharmaceutical Sales Database
CurrentlyQilu PharmaceuticalEleven diabetes medications have been approved for marketing in China, includingCanagliflozin Tablets, Sitagliptin Metformin Tablets (Ⅱ), Linagliptin Metformin Tablets (Ⅰ), Linagliptin Metformin Tablets (Ⅱ), Linagliptin Tablets, Phosphate Sitagliptin Tablets, Saxagliptin Tablets, Metformin Vildagliptin Tablets (Ⅱ), Nateglinide Tablets, Metformin Hydrochloride Tablets, Vildagliptin Tablets.
Screenshot source:PharmCube China Drug Approval
2023 to PresentQilu PharmaceuticalThere is11 ProductsClass 1 New DrugProceedIND Application andApproved for Clinical Use。Among them, the large molecule drugs includeSeven products, including four small-molecule chemical drugs.
Screenshot source: Pharma Intelligence China Drug Evaluation
In addition,Qilu PharmaceuticalAlso,Empagliflozin and Linagliptin Tablets, Empagliflozin Tablets, Dapagliflozin Tablets, Metformin and Empagliflozin Tablets (I), Metformin and Empagliflozin Tablets (VI), Sitagliptin and Metformin Extended-Release TabletsTablet 6PaymentNew Registration Submitted for Diabetes MedicationClassificationDeclaration，Among themEmpagliflozin and Linagliptin TabletsNo generic drug companies have been approved in China yet, and if successful, it is expected to secure the first generic approval.
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