芬戈莫德
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东阳光药业盐酸芬戈莫德胶囊国内首仿过评,原研药垄断局面被打破
Ge Long Hui· 2025-10-14 10:32
Core Insights - Guangdong Dongyangguang Pharmaceutical has received approval for the first domestic generic version of FingoMod (Fingolimod Hydrochloride Capsules) in China, marking a significant milestone as the first oral immunosuppressant for the company [1][8] - FingoMod, originally developed by Novartis and approved in the U.S. in September 2010, is the first oral treatment for relapsing forms of multiple sclerosis and has been included in China's first batch of urgently needed clinical drugs [5][8] - The global sales of FingoMod were impressive, exceeding $3.3 billion in 2018, with projected sales of over $500 million in 2024 [5] Company Overview - Dongyangguang Pharmaceutical is one of the early entrants in the FingoMod market, having initiated the project in July 2011 and submitted applications in China, the U.S., and the EU [8] - The company has successfully registered 18 products, with seven of them being the first to pass the evaluation process, including FingoMod, which breaks the original manufacturer's monopoly [11] Market Context - The approval of FingoMod comes at a time when only one other product, an import from India, is in the review stage, indicating a unique market position for Dongyangguang [11] - FingoMod was included in the National Medical Insurance Negotiation Directory in 2020 and is now part of the 2024 National Medical Insurance Regular Directory [5]