Qilu Pharmaceutical Files for China's First Generic of $300M Global Blockbuster Mirogabalin Besylate Tablets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On November 26, according to the announcement on the CDE official website,Qilu Pharmaceutical (Hainan)SubmittedMirogabalin Besylate TabletsThe listing application has been accepted.According to the statistics from the Mosentropy Medical Database, 2023Mirogabalin Besylate TabletsInGlobal sales have approached $300 million.
Screenshot source: CDE
Milnacipran Besylate TabletsIt is an original research product of Daiichi Sankyo, a new-generation calcium ion channel modulator, indicated for diabetic peripheral neuropathic pain (DPNP). In January 2019, the drug was approved for the first time in Japan, and its application covers the treatment of peripheral neuropathic pain (PNP). As an imported drug that is urgently needed in clinical practice,Mirogabalin Besylate TabletsSince its launch, global sales have continued to grow rapidly. According to statistics from the Mosec Pharma database, in 2023Milnacipran Besylate TabletsInGlobal sales have approached $300 million, with a year-on-year increase of 12.26%.
Screenshot source:Moxie Medicine Global Drug Research and Development Database
Currently, apart from the original research enterprise, no other pharmaceutical companies in China have obtainedMirogabalin Besylate TabletsProduction License. In the generic drug field, only Nanjing Chia Tai Tianqing Pharmaceutical and Qilu Pharmaceutical (Hainan) have submitted Class 4 new generic drug registration applications. Among them, Nanjing Chia Tai Tianqing Pharmaceutical was the first to complete the bioequivalence trial for this drug, moving into the market application stage from September to November 2023, showcasing extremely high efficiency. Meanwhile, Qilu Pharmaceutical (Hainan) followed closely, initiating a similar trial in July, which means that the first generic drug is likely to emerge from one of these two pharmaceutical companies.
Screenshot source:Moxie Medicine China Drug Approval Database
Since the beginning of this year, Qilu Pharmaceutical has also submittedBrexpiprazole Orally Disintegrating Tablets, Sodium Rabeprazole for Injection, Micafungin Sodium for Injection, Siponimod Tabletsetc. 26 products(Including subsidiaries)Generic applications, whereMilnacipran Besylate Tablets, Fluticasone Propionate Nasal Spray, Brexpiprazole Orally Disintegrating Tablets, Brexpiprazole Tablets, Clevidipine Butyrate Injectable Emulsion, Beclomethasone Dipropionate Tablets, Lifitegrast Eye Drops, Lusutrombopag Tablets, Siponimod Tablets, Palonosetron Hydrochloride Soft Capsules, Aripiprazole for Injection, Olanzapine for InjectionTwelve products have not yet received approval for domestically produced generic drugs, and the company is expected to compete for the first domestic generic drug approval in China.
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