Qilu Pharmaceutical Secures Dual Approvals for $1.6B Dapagliflozin/Metformin Extended-Release Tablets, Becomes Fourth Domestic Manufacturer
Qilu Pharmaceutical
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On February 13, according to the latest information on the NMPA official website,Qilu PharmaceuticalSubmitted Category 4 Chemical Generic DrugsDapagliflozin Metformin Sustained-Release Tablets (Ⅰ)AndDapagliflozin Metformin Sustained-Release Tablets (Ⅲ)Approved on the same day and deemed to have passed the consistency evaluation, both securing the 4th domestically produced.
Screenshot source: NMPA
$1.6 Billion Compound Antidiabetic Drug, the 4th Chinese-Produced Version Arrives!
Dapagliflozin Metformin Sustained-Release TabletsOriginal Research byAstraZenecaCompany R&D. October 2014,Dapagliflozin Metformin Sustained-Release TabletsApproved by the FDA for marketing, this variety is the first SGLT2 inhibitor approved in the United States.Metformin Hydrochloride Sustained-Release TabletsA once-daily oral combination drug. In June 2023, AstraZeneca'sDapagliflozin Metformin Sustained-Release TabletsApproved by NMPA for the treatment of type 2 diabetes. According to statistics, the global sales volume of dapagliflozin metformin sustained-release tablets is approximately 2 billion tablets, with sales reaching about 1.6 billion US dollars. According to the Mosecure Pharma database, China's diabetes medication market continues to maintain steady growth, and in 2024...（Q1~Q3）Sales in the Chinese hospital market have exceeded 30 billion yuan, with unlimited market potential.
Screenshot source:Mox Entropy PharmaceuticalsNational Hospital Sales Database
Previously,Dapagliflozin Metformin Sustained-Release TabletsIn the market landscape, apart from the original research product, domestically produced alternatives have been approved for Xuantai Pharmaceutical, Nanjing Chia Tai Tianqing Pharmaceutical, and Beijing Fuyuan Pharmaceutical. Among them, Xuantai Pharmaceutical was the first to receive approval in September 2024, becoming the first company in China to obtain qualification for this generic drug variety. Subsequently, Nanjing Chia Tai Tianqing Pharmaceutical became the second Chinese company to gain approval, while Beijing Fuyuan Pharmaceutical followed closely in 2025, securing its position as the third Chinese producer. This time, Qilu Pharmaceutical...Dapagliflozin Metformin Sustained-Release TabletsThe fourth approval in China will further intensify the competition in the domestic hypoglycemic drug market.
Screenshot source:MoxEntropy Pharmaceuticals Approved Drugs Summary Database
As of now, 16 companies, including Jiangsu Wango Pharmaceutical, Shandong Lukang Pharmaceutical, and Cisen Pharmaceutical, have developed generic versions of this drug and entered the application stage for market approval.
Under the centralized procurement policy, the retail market position of metformin remains stable.
MetforminAs a first-line treatment for Type 2 diabetes management and the preferred option for combination therapy, its market size is quite considerable, especially in the field of compound drugs.MetforminThe combination model of "+ other oral hypoglycemic agents" is extremely common, firmly occupying the core position in the market for biguanide and oral hypoglycemic compound drugs. With a clinical application history of over 60 years,Metformin, whose efficacy and safety have been widely recognized. In August 2020,MetforminThe oral immediate-release and extended-release formulations have been included in the third batch of China's national centralized drug procurement list. This move has significantly reducedMetforminThe price, including oral conventional release dosage forms(0.5g specification)The price has dropped significantly from 0.4 yuan per tablet before the centralized procurement to about 0.06 yuan, and the daily treatment cost has also decreased from 1.6 yuan to 0.24 yuan.
Despite the impact of the national centralized procurement policy,MetforminSales in hospitals slightly declined, but in China's national pharmacy retail market, its leading position remains unshakable. 2022,MetforminIn the retail market, sales exceeding 4.2 billion yuan have reached their peak.
Screenshot source:Moxie Medicine China Pharmacy Retail Database
From the overall situation of China's national drug procurement, oral diabetes drugs have been involved in multiple batches:The second batch includes 2 drugs, the third batch includes 2, the fourth batch includes 5, the fifth batch includes 3, the seventh batch includes 2, and the ninth batch includes 1, totaling 15 oral diabetes drugs included in the centralized procurement scope.The implementation of these policies has not only reduced the medication costs for patients but also driven the transformation and development of the diabetes drug market in China.
Qilu Pharmaceutical's recent approval of Dapagliflozin Metformin Sustained-Release Tablets undoubtedly adds new competitiveness to the company in the hypoglycemic drug field. As competition in China's hypoglycemic drug market intensifies, domestic pharmaceutical companies like Qilu Pharmaceutical will face more opportunities and challenges. Meanwhile, the continued deepening of the centralized procurement policy will further drive changes and development in China's diabetes drug market.
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