Rare Daily Staff

Viela Bio said it entered into a collaboration with Hansoh Pharmaceutical Group to develop and commercialize in China inebilizumab, Viela’s humanized anti-CD19 monoclonal antibody for neuromyelitis optica spectrum disorder (NMOSD) and other potential indications.

NMSOD is a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis.

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.

“Our collaboration with Hansoh Pharma strengthens our ability to commercialize inebilizumab throughout the world,” commented Bing Yao, Viela’s executive chairman and CEO. “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.

“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, president of Hansoh Pharma. “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 NMOSD. Viela expects to file an application with U.S. Food and Drug Administration in mid-2019 for approval to market inebilizumab.

Photo: Bing Yao, Viela’s executive chairman and CEO

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