29 May 2019 - - US-based biotechnology company Viela Bio, Inc and China-based biopharmaceutical company Hansoh Pharmaceutical Group Company Ltd have forged a collaboration focused on development and commercialisation of inebilizumab Viela's humanized anti-CD19 monoclonal antibody in China for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential inflammation/autoimmune and hematologic malignancy indications, the companies said.

Under terms of the collaboration, Viela will receive an up-front collaboration fee and additional payments contingent on certain development, regulatory, and commercial milestones, totaling potentially more than USD220 m, plus tiered royalties on net sales.

Hansoh Pharma will be responsible for leading development and commercialization of inebilizumab in China.

Viela recently presented positive results from a pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Inebilizumab is not yet approved for sale in either the United States or China.

Viela expects to file for a Biologics License Application with the US Food and Drug Administration in mid-2019.

Inebilizumab is a humanised monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation.

Inebilizumab is an investigational new drug for which there is no marketing authorization in the United States or China.

Hansoh Pharma is a biopharmaceutical company in China.

Founded in 1995, Hansoh has fully integrated research and development, manufacturing and commercial capabilities, supporting a leadership position in CNS, oncology, infectious diseases, and diabetes, among others.

Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.