Another Rare Disease Drug Approved for Neuromyelitis Optica Spectrum Disorder (NMOSD)

　　【Pharmaceutical Network Product Information】Neuromyelitis Optica Spectrum Disorder (NMOSD) is an inflammatory demyelinating disease of the central nervous system, characterized by high recurrence and high disability rates, and it predominantly affects women. Data shows that in 2020, the patient population with neuromyelitis optica spectrum disorder in China was approximately 48,900 people, and it is estimated that by 2025, the patient population in China will reach 51,200 people.
 

Studies have shown that over 90% of patients with this disease experience a relapsing course; approximately 60% of patients relapse within one year, and 90% relapse within three years. Most patients are left with severe visual impairment (blindness), limb dysfunction (paraplegia), and urinary and fecal dysfunction. Therefore, there is a significant unmet treatment need for reducing relapses and improving prognosis in these patients. The disease was included in China's first national list of 121 rare diseases in May 2018. With the continuous advancement of medicine and the acceleration of new drug review and approval, pharmaceutical companies are increasingly focusing their efforts on the NMOSD field.
 

Currently, in China, medicines for treating this disease include Roche's Tocilizumab (Satralizumab), which was approved for marketing in China in May 2021, becoming the first NMOSD treatment drug in China. Recently, there has been news of another new drug being approved.
 

On March 11, information from the National Medical Products Administration showed that Inebilizumab Injection has been approved. This drug is the first innovative biologic introduced by Hansoh Pharma, used for treating adult patients with "Neuromyelitis Optica Spectrum Disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies."
 

It is reported that on May 28, 2019, Hansoh Pharma and Viela Bio announced a collaboration to develop inebilizumab injection, an anti-CD19 monoclonal antibody, in China for the treatment of NMOSD, autoimmune diseases, and hematologic malignancies. According to the agreement, Hansoh Pharma will pay Viela Bio over US$220 million in upfront and commercial milestone payments.
 

Inebilizumab injection is also the world's first humanized anti-CD19 monoclonal antibody approved for the treatment of AQP4 antibody-positive NMOSD adult patients, with no current competitors. The product was granted Orphan Drug Designation by the US FDA and the European Medicines Agency in 2016 and 2017, respectively, and received Breakthrough Therapy Designation (BTD) from the US FDA. In June 2020, it received approval from the US FDA for marketing, and in March 2021, it obtained marketing approval from Japan’s Ministry of Health, Labour and Welfare.
 

In October 2020, the product initiated its application process in China, becoming the first anti-CD19 monoclonal antibody to be submitted for marketing authorization in the country. According to available evidence, Inebilizumab injection, as a humanized IgG1 monoclonal antibody, depletes CD19 B cells through ADCC, achieving broader and longer-lasting B cell depletion. This significantly reduces the relapse rate of NMOSD while maintaining reliable safety, providing comprehensive benefits to patients. With the approval and market launch of this new drug, it is expected to offer better treatment options for NMOSD patients in China and improve their quality of life.
 

Currently, in addition to imported products, a number of drugs for NMOSD treatment produced by Chinese pharmaceutical companies are on the way to market. For example, on March 2, InnoCare Pharma announced that its Bruton's Tyrosine Kinase (BTK) inhibitor, orelabrutinib, used for the treatment of NMOSD, has passed the Investigational New Drug (IND) review by the China National Medical Products Administration (NMPA) and has been approved to conduct Phase II clinical trials in China. A co-founder of the company stated that, considering the pathogenesis of NMOSD and the mechanism of action of orelabrutinib, they believe orelabrutinib will bring new treatment options for NMOSD.
 

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