Qilu Pharmaceutical Secures China's First Generic Approval for Tafamidis Meglumine Soft Capsules, a $3.3 Billion Blockbuster Rare Disease Drug
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On June 18, according to the official website of NMPA,Qilu PharmaceuticalSubmitted Generic Drug Class 4Patisiran Soft CapsulesApproved for production, as the first generic + the first to pass the evaluation in China. From 2024 to date, Qilu Pharmaceutical has had five products become the first to pass the evaluation.
Screenshot source:NMPA
Chlorbenzazole(Vyndaqel)Original Research fromPfizerIt is a rare disease medication that prevents the breakdown of transthyretin, thereby inhibiting the formation of amyloid fibrils and slowing the progression of neuropathy. It is suitable for transthyretin amyloidosis polyneuropathy.(ATTR-PN)Treatment.Once Pfizer's original drug was launched, its sales quickly expanded. According to the Pharma Intelligence Cloud database,ChlorbenzazoleGlobal sales of the product exceeded $2 billion in 2022. Pfizer's financial report shows that Vyndaqel generated sales of up to $3.321 billion for Pfizer in 2023.
Currently, in the Chinese marketPatisiran Soft Capsules, Patisiran Sodium Soft CapsulesOnly Original ResearchPfizerApproved. Qilu Pharmaceutical, Nanjing Chia Tai Tian Qing PharmaceuticalTafamidis Methylglucamine Soft CapsulesIn January and February 2023, generic drug applications were successively submitted. This time, Qilu Pharmaceutical Co., Ltd.Tafamidis Methylglucamine Soft CapsulesSuccessfully approved, achieving the first domestic generic + first to pass the evaluation in China.
In terms of generic drug layout, Qilu Pharmaceutical Co., Ltd. has submittedDasatinib Tablets, Riociguat Tablets, Ixazomib Citrate Capsules, Carfilzomib for InjectionThe generic applications for 63 varieties, including [drug names], are all under review and approval.
In addition, Qilu Pharmaceutical(Including Subsidiaries)More than 160 varieties have passed the evaluation, among whichPatisiran Soft Capsules, Cefpodoxime Proxetil Tablets, Bendamustine Hydrochloride Injection ConcentrateThe 56 varieties, including [specific drug names], were the first to pass the evaluation.
From 2024 to present, Qilu Pharmaceutical(Including subsidiaries)There isChlorbenzazole Ammonium Soft Capsules, Pomalidomide Capsules, Cefotaxime Sodium for Injectionetc. 17 in total（Five Firsts）Product Variety Approval, among whichPatisiran Soft Capsules, Bendamustine Hydrochloride Injection ConcentrateAs the first domestic generic,Pomalidomide CapsulesThe second domestically approved,Eltrombopag Ethanolamine TabletsThe third domestically produced product approved in China.
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