Sanofi is approved the listing of rare disease drugs in China


    Sanofi is approved in China for the treatment of a new drug for relapsing multiple sclerosis, Obajie (Terifluide tablets). The drug is the first oral dosage form approved for multiple sclerosis in China.

    Multiple sclerosis is a lesion in multiple parts of the nervous system that protects the myelin membrane of the central nervous system from attack. Patients with multiple sclerosis are basically young adults aged 20-40 years old, mostly in women, about twice as many as men. The disease is highly prevalent in the West, with a prevalence rate of 1 in 1000 in Europe and the United States, and a lower incidence in Asia. It is estimated that there are more than 60,000 patients suffering from this disease in China.

    Triflurane was developed by Sanofi Aventis under the trade name Aubagio. And on September 12, 2012, the FDA approved the treatment of relapsing multiple sclerosis drugs. The drug is an immunomodulator that blocks the synthesis of pyrimidine by inhibiting dihydroorotate dehydrogenase.

    Triflurane is an in vivo active metabolite of leflunomide. Leflunomide is a treatment for rheumatoid arthritis. Leflunomide can be rapidly and almost completely converted to teriflamine after oral digestion. Currently, teriflamine has become the focus of treatment for multiple sclerosis.

    In the global market in 2014-2017, Obati (Terifluamine) increased from 580 million US dollars to nearly 2 billion US dollars, compound growth rate of more than 50%, the market growth is strong. In recent years, recurrent multiple sclerosis treatment has changed rapidly, and emerging oral and parenteral treatments are being developed and developed. Among them, teriflamine has shown good clinical efficacy and safety as a novel drug for changing disease progression. It has become an eye-catching drug for the current treatment of relapsing multiple sclerosis. And the drug leflunomide adds evidence of long-term good safety to teriflamine.

    This drug not only provides a new treatment option for relapsing multiple sclerosis, but also provides an approved treatment for primary progressive multiple sclerosis for the first time, which is of great significance for patients with multiple sclerosis.