Multiple sclerosis (MS) is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system. It often involves periventricular, near cortical, optic nerve, spinal cord, brainstem and cerebellum. The lesions are characterized by spatial and temporal multiple lesions. Most of them were young and middle-aged people aged 20-40. Female patients were about 1.5-2 times of male patients. At present, more than 2 million 300 thousand people worldwide have multiple sclerosis, with an incidence rate of about 0.03%. The prevalence in Europe and America is higher than that in Asia.
Currently, 325000 patients with multiple sclerosis (MS) are receiving treatment in the United States, of which 75% are relapsing remitting multiple sclerosis (RRMS); there are 15000 new cases each year.
Due to the lack of large-scale epidemiological data, our country is expecting more than 30 thousand patients (referred to the incidence rate in Asia, Japan and South Korea), and relatively rare diseases. We expect to see more accurate figures in the near future. In May 2018, multiple sclerosis was included in the first batch of rare diseases list in China.
In December 2015, all patients with multiple sclerosis were enrolled in the study. With this approval, genmab received a $30 million milestone payment from Novartis.
Attachment:
Domestic innovative pharmaceutical enterprises in the field of multiple sclerosis include: hmpl-523 (Syk inhibitor targeting spleen tyrosine kinase) of Hutchison Whampoa, cbp-307 (S1P1 regulator) of kangnaide biology, zd03 of Zhendong Pharmaceutical (a new type of small molecule drug derived from natural products), bat-4306f (CD20 monoclonal antibody) of baiaotai biological, and S1P1 regulation of Beijing Fulong Kangtai biological Co., Ltd Fp-253 / fp-264 and so on. The future of multiple sclerosis needs to target the international market.
reference resources:
NMPA/CDE；
Drug melting circle data;
FDA/EMA；
Public disclosure of related companies;
https://www.novartis.com/news/media-releases/fda-approves-novartis-kesimpta-ofatumumab-first-and-only-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis；
https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptance-ofatumumab-novel-b-cell-therapy-patients-relapsing-forms-multiple-sclerosis-rms；
https://www.novartis.com/investors；
https://www.ocrevus.com/；
https://novartis.gcs-web.com/FDA-approves-Novartis-Kesimpta-ofatumumab-the-first-and-only-self-administered-targeted-B-cell-therapy-for-patients-with-relapsing-multiple-sclerosis?_ga=2.159214778.1426438003.1597997053-1015316644.1586843555；
https://novartis.gcs-web.com/static-files/45572026-e420-4ed7-9f22-2655836a9748；
Multiple sclerosis tissue, https://www.nationalmssociety.org ;
https://www.mssociety.org.uk ;
International Federation of multiple sclerosis, https://www.msif.org ;
Chinese Journal of neuroimmunology and neurology, 2018 (06): 387-394; https://www.cn-healthcare.com/article/20190103/content-513294.html ; and so on.
