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TextPharmaceutical Guanlan
On January 5, the official website of the China National Medical Products Administration (NMPA) announced that Shengshi Taike's generic drug Teriflunomide was officially approved in China
.
According to the priority review announcement of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, the approved indication for this drug is relapsing multiple sclerosis
.
Screenshot source: NMPA official website
Multiple sclerosis (MS) is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system that disrupts the normal function of the brain, optic nerve and spinal cord through inflammation and tissue damage
.
The clinical manifestations of MS are diverse and involve a wide range of sites.
Repeated attacks of the disease can eventually lead to disability or even death
According to public information, teriflunomide is an immunomodulatory agent with anti-inflammatory effect, which can inhibit dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo synthesis of pyrimidine
.
Studies have shown that the mechanism of action of the drug in the treatment of MS may be related to the reduction of the number of activated lymphocytes in the central nervous system
.
Previously, the original teriflunomide drug from Sanofi has been approved for multiple indications worldwide, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), relapsing secondary progressive MS (SPMS) ) and so on
.
In July 2018, the original research drug teriflunomide was approved for marketing in China for the treatment of relapsing MS
.
In March 2020, Shengshi Tech submitted two marketing applications for teriflunomide generic drugs in China, 7mg and 14mg respectively
.
These two marketing applications were subsequently included in priority review by CDE on the grounds of rare diseases, and the proposed indications were: relapsing multiple sclerosis
.
Image source: CDE official website
It is worth mentioning that in recent years, China has approved a number of MS treatment drugs, including selective immunosuppressants, and potassium channel blockers that can improve walking dysfunction in MS patients, and many products have been included through negotiation.
References:
[1] China State Food and Drug Administration's January 5th Drug Approval Document Pending Information.
[3] This report is released 2.
[4] Negotiated medicines during the agreement period.
