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Regeneron, Zai Lab Enter Strategic REGN1979 Alliance

Regeneron will receive $30 million upfront and is eligible to receive up to $160 million in additional regulatory and sales milestones.

By: Contract Pharma

Contract Pharma Staff

Regeneron Pharmaceuticals, Inc. and Zai Lab Ltd. entered a strategic collaboration for the development and commercialization of REGN1979 (CD20xCD3 bispecific antibody) in mainland China, Hong Kong, Taiwan and Macau. The collaboration will support global clinical development for REGN1979, starting with the ongoing Phase II program in B-cell non-Hodgkin lymphoma (B-NHL).

If REGN1979 is approved, Zai Lab will leverage its capabilities to commercialize REGN1979 in this region. REGN1979 is the most advanced investigational bispecific monoclonal antibody from Regeneron’s bispecific platform and is designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).

Regeneron will receive a $30 million upfront and is eligible to receive up to $160 million in additional regulatory and sales milestones. Zai Lab will contribute to the global development costs for REGN1979 for certain trials and will receive the rights to develop and commercialize REGN1979 in oncology in mainland China, Hong Kong, Taiwan and Macau. Additionally, Zai Lab will make payments to Regeneron based on sales. Regeneron will be responsible for the manufacture and supply of REGN1979 for development and commercialization in the region.

REGN1979 was granted orphan drug designation by the U.S. FDA for the treatment of follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). REGN1979 is currently being investigated as a treatment for late stages of FL, DLBCL and other lymphomas in a Phase I trial as well as a potentially registrational Phase II trial.

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