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On March 9th, the CDE official website showed that the application for the listing of the 4 generic generic drug teriflunomide tablets by Chenxin Pharmaceutical was accepted.
The original research Teriflunomide (Teriflunomide) is an oral pyrimidine synthase inhibitor and immunomodulator developed by Sanofi.
Multiple sclerosis (MS) is a serious, lifelong, progressive, and disabling demyelinating disease of the central nervous system.
At present, MS cannot be cured, but acute hormone shock therapy and disease modification therapy (DMT) can be used to control the inflammatory response and inhibit the activity of immune cells, so as to reduce the number of relapses, delay the progression of the disease, and improve the prognosis.
Teriflunomide is easy to use and only needs to be taken once a day.
In China, teriflunomide was approved by the NMPA for the treatment of relapsing MS in July 2018, and its trade name is Aubage, becoming the first oral DMT drug approved for marketing in my country.
At present, teriflunomide has been recommended as the first-line oral treatment drug in DMT by the "Chinese Multiple Sclerosis Expert Consensus" (2018 edition).
It is reported that the price of a box (14mg*28 tablets) of teriflunomide is 8,290 yuan, which is still not a small burden for MS patients who need long-term medication.
In addition, it is worth mentioning that, with the country’s emphasis on rare diseases and the reform of the approval system, my country has approved a number of oral DMT drugs in recent years, such as fingolimod (trade name: Jelingya) and Sinimod Germany (trade name: Wan Li Neng) and teriflunomide, among which Fingolimod and Sinimod were successfully shortlisted for 2020 medical insurance.
However, there are currently 4 MS drugs included in the "Clinical Urgently Needed Overseas New Drugs List", and three other MS drugs have not been approved.
It is reported that only 10% of MS patients in my country use standard DMT treatment, which is far lower than the DMT use rate (86%) in European and American countries.
