August 5, 2021

Inebilizumab has been approved in South Korea
for Neuromyelitis Optica Spectrum Disorder
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President &Representative Director, CEO: Hiroaki Ueno), announced today that Mitsubishi
Tanabe Pharma Korea (MTPK) (Head Office: Hwaseong, Gyeonggi-do, South Korea;
President & Representative Director, CEO: Osamu Yomogida), MTPCʼs subsidiary inSouth Korea obtained the regulatory approval of UPLIZNA® injection (generic name:inebilizumab (genetically modified), Japan names: UPLIZNA Ⓡ for I.V. Infusion100mg) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) on
August 5, 2021.
UPLIZNA is a drug for the treatment of NMOSD with a new mechanism of which
MTPC obtained license from Horizon Therapeutics plc (Horizon). Horizon received
approval in the U.S. in June 2020. In Japan, MTPC received approval in March 2021
and has been marketing since June 2021.
It has been reported that the prevalence of NMOSD in South Korea is relatively highamong Asian countries. In recent years, the number of patients has been increasing
as diagnostic techniques have improved and there is a growing interest in diseases1.
Because of the convenience of a dosing interval of once every six months, UPLIZNA
enables treatment tailored to the lifestyle of patients, and it can be provided as a
new treatment option for NMOSD patients in the relapse prevention period.
Since its establishment in 1989 by MTPC, MTPK has been conducting businessactivities in South Korea for more than 30 years. In South Korea, MTPK are focusing
on the central nervous system and have marketed Radicut, a drug for the treatmentof amyotrophic lateral sclerosis since 2016. In 2020, MTPK filed an application forapproval of Valbenazine (MT-5199) for the treatment of tardive dyskinesia. Throughfurther expansion of the product lineup with the approval of UPLIZNA, MTPK will
strengthen our business base in the central nervous system area.
By bringing treatment options to patients fighting against NMOSD, MTPC will strive
to improving the quality of life of patients.

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1

Kim JE, Park SH, Han K, Kim HJ, Shin DW, Kim SM: Prevalence and incidence of neuromyelitis optica

spectrum disorder and multiple sclerosis in Korea. Mult Scler. 2020; 26(14):1837-1844.

Mitsubishi Tanabe Pharma Corporation
Communication Crossroads Department
Media contacts: TEL: +81 6 6205 5119

About inebilizumab
Inebilizumab is a humanized anti-CD19 monoclonal antibody of which MTPC
obtained license Horizon Therapeutics plc (formerly Viela Bio, Inc.). It binds to aprotein called CD19 which is expressed on B cells including antibody-producing
plasmablasts and plasma cells, and rapidly depletes these cells from the circulation
to prevent relapse in NMOSD.
About Neuromyelitis Optica Spectrum Disorder (NMOSD)NMOSD is a rare, severe, relapsing, autoimmune disease of the central nervous
system that can be fatal. The body's immune system reacts against healthy cells(most commonly in the optic nerve, spinal cord and brain), resulting in NMOSD
attack and severe damage. It may cause pain in the eye and vision loss, severe
muscle weakness and paralysis, numbness, loss of bladder and bowel control andrespiratory failure2. The disease is primarily associated with anti-aquaporin 4(AQP4) antibodies, which are detected in approximately 73%-90% of patients withNMOSD3.
2

National Institute of Neurological Disorders and Stroke, National Institutes of Healthhttps://www.ninds.nih.gov/Disorders/All-Disorders/Neuromyelitis-Optica-Information-Page

3

Chang VTW, Chang HM. Review: Recent advances in the understanding of the pathophysiology ofneuromyelitis optica spectrum disorder. NAN. 2020; 46:199-218.

About Mitsubishi Tanabe Pharma Korea Co., Ltd.
Mitsubishi Tanabe Pharma Korea Co., Ltd. (MTPK) is a South Korean subsidiaryestablished in April 1989 with a 100% investment by MTPC. MTPK is one of the few
foreign-affiliated pharmaceutical companies operating in South Korea withdevelopment, manufacturing and sales functions and is rooted in South Korea.

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