Qilu Pharmaceutical Secures First-to-File Status in China for Ixazomib Citrate Capsules, a 500-Million-Yuan Market Opportunity
Qilu Pharmaceutical
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The CDE official website shows,Qilu PharmaceuticalSubmitted Category 4 Generic Chemical DrugIxazomib Citrate CapsulesThe marketing application has been accepted. Currently, it is the first marketed application in China.IxazomibGeneric drugs are expected to secure the first generic approval.
Source: CDE official website
Ixazomib（Ixazomib）Is an orally administered, highly selective proteasome inhibitor, developed byTakedaQilu Pharmaceutical Co., Ltd.'s Millennium Pharmaceutical Research and Development obtained the U.S. Food and Drug Administration on November 20, 2015.（FDA）The marketing approval was granted by the European Medicines Agency on November 21, 2016. In 2011, it received orphan drug designation from the US FDA and EU EMA for the treatment of multiple myeloma. The drug was further approved by Japan's Pharmaceuticals and Medical Devices Agency on March 30, 2017.（PMDA）Approved for marketing, obtained approval from the China National Medical Products Administration on April 12, 2018.（CFDA）Approved for marketing under the trade name Ninlaro®/恩莱瑞®.
According to the PharmaCloud database,IxazomibSince its launch, sales have increased significantly, reaching a peak in 2021.RMB 540 million, followed by a slight decline.Currently, this variety is only approved for production by the original research company, and no other generic drugs have been approved yet.
Screenshot source: Pharma Intelligence China Hospital Sales Database
According to the data from PharmaCloud, Qilu Pharmaceutical is the first company in China to apply for the marketing of a generic version, and no other companies have entered the market yet.
Qilu Pharmaceutical has had 28 drugs pass the consistency evaluation this year, among whichOlaparib Tablets, Injectable Octreotide Acetate Microspheres, Pazopanib Tablets, Dolutegravir Sodium Tablets, Probucol Tablets, and Injectable Ertapenem SodiumAll 6 products are the first to pass the evaluation. Overall, as of now, Qilu Pharmaceutical has a total of 141 products that have passed the consistency evaluation, of which 54 are the first in China.
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