According to the official website of the NMPA, the handling status of fingolimod’s marketing application has changed to "under approval", which is likely to be marketed this month.
Fingolimod is a new immunosuppressant developed by Novartis, A blockbuster in the MS area.

Only 2 MS drugs in China
MS is an autoimmune disease with the main characteristic of protein inflammatory demyelinating disease of the central nervous system (CNS). There are about 2.50 million people affected by MS in the world, mainly the population aged 20-40, with the number of female patients twice that of male patients. The cause is unknown and generally considered to be relating to inheritance, environment, and autoimmunity, etc.
MS is divided into 4 subtypes, with each having their characteristics.
Subtype | Characteristic |
RRMS | More than 80% newly diagnosed patients belong to RRMS; RRMS patients have defined recurrent clinical events and then experience a complete or partial remission for months or years until next recurrent events |
Secondary progressive MS (SPMS) | If untreated, about 40% RRMS patients will become SPMS patients, accompanied by the increase of the disability degree and reduction of the remission event frequency |
Primary progressive MS (PPMS) | PPMS occurs in about 10% MS patients; there is no defined boundary between the relapsing period and remitting period. PPMS is a very malignant disease and there had been no progress of treatment for dozens of years until the occurrence of ocrelizumab (trade name: Ocrevus) |
Progressive-relapsing MS (PRMS) | PRMS is characterized by clear disease progression and acute relapsing |
(Sorted out according to public data)
There is still no effective therapy to cure MS, and the treatment is still based on disease-modifying therapy (DMT) clinically. Drugs for MS are mainly divided into immunomodulator, immunosuppressor, and anti-inflammatory agent.
According to the Rare Disease Diagnosis and Treatment Guidelines and the public data of the international MS community, there have been 16 MS drugs marketed so far. IFNβ and glatiramer acetate (trade name: Copaxone) are first-line therapies for relapsing MS, administered by subcutaneous injection or intramuscular injection. Natalizumab (trade name: Tysabri) and mitoxantrone (trade name: Novantrone) are mainly used as second-line therapies that shall be administered by intravenous drip with the help of professional medical personnel.
Patients have strong demands for oral drugs of MS as it is a chronic disease that requires long-term medication. There is a total of 3 oral MS drugs marketed in the world, separately Fingolimod Hydrochloride (trade name: Gilenya), Teriflunomide (trade name: Aubagio), and Dimethyl Fumarate (trade name: Tecfidera).
Pharmaceutical product name | Trade name | FDA approval time | NMPA approval time | Indication |
Fingolimod | Gilenya | Sep. 2010 | / | RRMSRead More
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