Shengshi Tech's Generic Teriflunomide Approved in China for Relapsing Forms of Multiple Sclerosis

By Medicine Perspective

On January 5, the official website of China's National Medical Products Administration (NMPA) announced that CGeneTech's generic drug Teriflunomide tablets had been officially approved in China. According to the priority review announcement by the Center for Drug Evaluation (CDE) under the NMPA, the approved indication for this drug is relapsing multiple sclerosis. Teriflunomide is an immunomodulator with anti-inflammatory effects, originally developed by Sanofi and already approved for marketing in China. The approval of CGeneTech’s generic version of Teriflunomide will provide new treatment options for patients with multiple sclerosis.

Screenshot source: NMPA official website

Multiple Sclerosis (MS) is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system, which disrupts the normal function of the brain, optic nerves, and spinal cord through inflammation and tissue damage. The clinical manifestations of MS are diverse, affecting a wide range of areas, and repeated attacks can eventually lead to disability or even death. In May 2018, MS was included in China's First List of Rare Diseases.

Public information shows that teriflunomide is an immunomodulator with anti-inflammatory properties, which can inhibit dihydroorotate dehydrogenase, a mitochondrial enzyme involved in the de novo synthesis of pyrimidines. Studies suggest that the mechanism of action of this drug in treating MS may be related to the reduction in the number of activated lymphocytes in the central nervous system.

Previously, the original research drug teriflunomide from Sanofi has been approved globally for multiple indications, including Clinically Isolated Syndrome (CIS), Relapsing-Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis with relapses (SPMS), and more. In July 2018, the original research drug teriflunomide was approved for marketing in China for the treatment of Relapsing Multiple Sclerosis. In August 2020, the drug was also approved in China for the treatment of CIS.

In March 2020, CGeneTech submitted two marketing applications for its generic teriflunomide in China, with dosages of 7mg and 14mg. These two applications were subsequently granted priority review by the CDE on the grounds of being designated for a rare disease, with the proposed indication being: relapsing multiple sclerosis.

Image Source: CDE Official Website

It is worth mentioning that, in recent years, China has approved multiple MS treatment drugs, including selective immunosuppressants and potassium channel blockers that can improve walking dysfunction in MS patients. Moreover, several of these products have been included in the National Medical Insurance Catalog through negotiations, which is expected to benefit more patients.

References:

[1] Information on drug approval certificates pending collection from the National Medical Products Administration (NMPA) of China on January 5. Retrieved Jan 5, 2022, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220105143701157.html

[2] Heavyweight | Aubagio® – The First Oral Treatment for Multiple Sclerosis Approved in China. Retrieved July 25, 2018, from https://mp.weixin.qq.com/s/QLKAKeuJocOb5nuhADskRw

[3] This report release 2.0: Rare, Strong, and Proud. Retrieved Feb 27, 2021, from https://mp.weixin.qq.com/s/4T3-W_FGxjsqS3vhfMWoSg

[4] Negotiated Drugs During the Agreement Period. Retrieved Dec 3, 2021 from http://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=cdcba5a2f0d74afc945c11296f0f8d87.pdf

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