Viela Bio, Inc. (“Viela”) and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”) today announced a collaboration focused on development and commercialization 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.
“Our collaboration with Hansoh Pharma strengthens our ability to commercialize inebilizumab throughout the world,” commented Bing Yao, Ph.D., Viela’s Executive Chairman and Chief Executive Officer. “Their significant commercial, regulatory and clinical development infrastructure gives us a strong strategic partner in China and also may provide support for our global product expansion and lifecycle plans.”
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 $220 million, plus tiered royalties on net sales. Hansoh Pharma will be responsible for leading development and commercialization of inebilizumab in China.
“We are thrilled to partner with Viela. They have shown that targeting CD19 to achieve sustained B cell depletion is a compelling monotherapy strategy that brings profound benefits to patients with NMOSD, for whom there is no approved therapy,” said Aifeng Lyu, Ph.D., President of Hansoh Pharma. “Viela is a leader in researching and developing breakthrough treatments for inflammation and autoimmune diseases. Together, we will endeavor to advance inebilizumab as quickly as possible for patients in China, as well as seek to broaden the potential of inebilizumab via combination therapies.”
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 U.S. Food and Drug Administration (FDA) in mid-2019.
Inebilizumab is a humanized 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.
ABOUT HANSOH PHARMACEUTICAL GROUP LIMITED
Hansoh Pharma is a leading biopharmaceutical company in China committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders, together with its 8,800 employees.
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. With 1,400 professionals across R&D, Hansoh ranks top 2 in innovation among all biotech and pharmaceutical companies in China based on new molecular entity INDs submitted for clinical development since 2011.
Hansoh Pharma’s 2018 revenue was US$1.1 billion, representing a year-over-year growth of 25%. For more information, please visit www.hansoh.cn/en/
ABOUT VIELA BIO
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.
For more information, please visit www.vielabio.com
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