Qilu Pharmaceutical Files for First-to-File Generic of Siponimod as Novartis' Originator Sees 127% Sales Surge in China
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Recently,Qilu PharmaceuticalSubmitted Category 4 Generic Chemical DrugSiponimod TabletsThe listing application has been accepted by the CDE. Currently, no generic versions of this product have been approved for production in China.
Screenshot source: CDE official website
SiponimodOriginal Research fromNovartis, is a sphingosine-1-phosphate（S1P）Receptor modulator, selective for S1P receptor subtype 1（S1P1）And Subtype 5（S1P5）High-affinity binding prevents lymphocytes from exiting lymph nodes, reducing the number of lymphocytes in peripheral blood. It was first approved by the FDA for marketing in 2019 for the treatment of adult relapsing forms of multiple sclerosis, including SPMS, RRMS, and CIS, making it the first oral drug approved by the FDA for the treatment of SPMS. According to PharmaCloud statistics, siponimod had global sales of $280 million in 2021, representing a year-over-year increase of 65%.
In 2020, the National Medical Products Administration approved a Class 1 innovative drug application from Novartis Pharma AG through the priority review and approval process.Siponimod Tablets(Product name: Wanli Neng)Launched for the treatment of adult relapsing multiple sclerosis.According toAccording to the PharmaCloud database,Siponimod TabletsIn2022China's hospital sales market exceeds50 million yuan, a year-on-year increase of 127%.
Screenshot source: PharmaCloud China Hospital Sales Database
Currently,Siponimod TabletsThe application for replication is very popular. Except Qilu PharmaceuticalQilu Pharmaceutical, Hunan Kelun Pharmaceutical Co.,Ltd.Already atIn February 2023, the company was the first to submit a generic drug marketing application under Category 4, which is currently under review and approval. With the entry of Qilu Pharmaceutical, the first-generic competition between the two leading companies has become increasingly intense.
Screenshot source:PharmCube China Drug Evaluation Database
According to the data from Pharma Intelligence, in 2023Qilu PharmaceuticalSubmittedPomalidomide Capsules, Dasatinib TabletsThe listing applications of 56 generic drugs are all under review and approval. Meanwhile, there are32 ProductsThe drug has been approved and is deemed to have passed the consistency evaluation, in which it has achievedPazopanib Tablets, Injectable Octreotide Acetate Microspheres, Dolutegravir Sodium Tablets, Paliperidone Palmitate Injection, Olaparib TabletsFive first-to-market generics.
Data Source:PharmCube Approval + Passing Data Integration
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