The patent of SimiGeluteptide has expired for more than a month, but there is no sign of a "domestic first certificate". Several applicant companies stated that the approval is "temporarily suspended" due to the data protection period.
The patent for the core compound of Simaglutide has expired for more than a month, and there is currently no domestic approval for the production of Simaglutide in China. Journalists recently learned from several domestic Simaglutide manufacturing companies in the capacity of investors that the relevant clauses of the China-Switzerland Free Trade Agreement may be the main reason. Among them, Jiuyuan Genetics stated, "The core reason we have not received approval is that the related data is still under protection," "It is currently just a suspended state, without a decision to approve or not, so it is difficult to draw a conclusion." The securities department of Livzon Group stated that, due to the impact of the China-Switzerland Free Trade Agreement, the approval process for Simaglutide is currently on hold, "From the company's perspective, all the information we submitted has been submitted, and the approval process has reached its final stage." Federal Pharmaceutical also stated, "We are now also waiting for approval, and the reason for not receiving approval is the same for everyone."
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