Novartis Submits New Drug Application for Fingolimod Hydrochloride in China

According to the official website of the National Medical Products Administration,NovartisFingolimod Hydrochloride submitted its marketing application in China on April 9 and is currently under review and approval, with the acceptance number JXHS1900046. It is understood that the product first applied for import of chemical drugs in June 2011 and obtained clinical trial approval in May 2013.

Fingolimod Hydrochloride byNovartis(Developed by Novartis, it was approved in the United States in September 2010 for the indication of multiple sclerosis (MS). In March of the following year, it was approved in the European Union, initially launched in Germany for the treatment of relapsing-remitting multiple sclerosis (RRMS). In Canada, the drug was approved for MS patients who were non-responsive to, intolerant of, or had failed other MS therapies. It was approved in Japan in September 2011 and launched there in November for the treatment of MS. In July 2014, the European Union further approved its use in patients with relapsing-remitting multiple sclerosis (RRMS) who had not responded to treatment with injectable interferon beta.)

Fingolimod Hydrochloride is a sphingosine-1-phosphate receptor (S1PR1/S1PR3/S1PR4/S1PR5) modulator that promotes the retention of lymphocytes in lymph nodes, thereby inhibitingAutoimmunityEfficacy of the response. This drug is indicated for the treatment of relapsing multiple sclerosis (MS) and can be used to reduce the frequency of clinical exacerbations and slow the progression of physical disability.

Data queries indicate that since its market launch in 2010, sales of fingolimod have continued to grow. In 2012, global sales successfully surpassed the $1 billion mark, reaching nearly $1.2 billion. From 2013 to 2016, sales continued to rise, with global revenues amounting to $1.947 billion, $2.499 billion, $2.803 billion, and $3.147 billion, respectively. Although fingolimod sales have maintained an upward trend thus far, Thomson Reuters predicts that while slight growth may persist over the next two years, sales will decline in the future.BioValleyBioon.com）