Hansoh Pharma Submits NDA for Inebilizumab, a First-in-Class CD19-Targeting Therapy for NMOSD

China Economic Net, February 28 (Reporter Guowang Zhu) February 28 this year marks the "International Rare Disease Day," with this year's theme being "Share Your Colors." The reporter learned from Hansoh Pharma that the biologic drug Inebilizumab Injection, introduced by Hansoh Pharma, has completed its market application and is expected to be approved for marketing soon. This is the world’s first and only CD19+B cell-depleting drug for treating the rare disease Neuromyelitis Optica Spectrum Disorder (NMOSD), and it has been granted breakthrough therapy designation by the U.S. FDA for NMOSD treatment.

The World Health Organization defines diseases with an incidence rate between 0.65‰ and 1‰ as rare diseases. Currently, more than 7,000 rare diseases have been identified globally. The latest definition of rare diseases in China refers to diseases with an incidence rate of less than 1 in 10,000 newborns, a prevalence rate of less than 1 in 10,000, and fewer than 140,000 patients. Due to China's large population base, there are approximately 20 million rare disease patients in the country. Limited clinical diagnostic awareness has led to significant difficulties in diagnosing rare disease patients, resulting in serious cases of misdiagnosis and missed diagnosis. Among confirmed rare diseases, less than 1% of patients in China have access to treatment options, and patients with neuromyelitis optica spectrum disorder (NMOSD) will be among this fortunate 1%.

NMOSD is a serious and rare autoimmune disease, with a global prevalence of 1.82 per 100,000. The disease is more commonly seen in Asian patients, with an average age of onset between 32.6 and 45.7 years, and it occurs more frequently in women. Patients constantly worry about disease relapses, each of which could lead to loss of vision, mobility, or even life, imposing significant financial and psychological burdens on both patients and their families.

Hansoh Pharma is a leading innovation-driven pharmaceutical company in China, dedicated to improving human health through continuous innovation while bringing globally leading diagnostic and therapeutic technologies and treatment drugs to more patients. In October 2020, Hansoh Pharma filed for the market approval of Inebilizumab Injection in China, making it the first CD19 monoclonal antibody to be submitted for marketing in the country.