Zai Lab and Regeneron Enter $190M Strategic Collaboration for Exclusive Rights to CD20xCD3 Bispecific Antibody REGN1979 in Greater China

Zai Lab and Regeneron Announce Strategic Collaboration for the Development and Commercialization of REGN1979, a CD20xCD3 Bispecific Antibody, in Mainland China, Hong Kong, Taiwan, and Macau

This collaboration will support the global clinical development of REGN1979, including an ongoing Phase II clinical study in B-cell non-Hodgkin lymphoma (B-NHL) that may serve as a registrational trial. Furthermore, upon regulatory approval of REGN1979 in China, Zai Lab will leverage its own commercialization team to advance the product’s commercial launch within the agreed-upon territories. REGN1979 is the most clinically advanced bispecific monoclonal antibody developed using Regeneron’s bispecific antibody platform. It is designed to kill cancer cells by binding to CD20, a protein on B-cell tumors, and CD3, a receptor on immune system T cells.

Under the agreement, Regeneron will receive a $30 million upfront payment and may be eligible for up to $160 million in regulatory and sales milestone payments. Zai Lab will share a portion of the global development costs for REGN1979 and will obtain exclusive rights to develop and commercialize the product in the oncology field in mainland China, Hong Kong, Taiwan, and Macau. In addition, Regeneron will receive a share of future revenues from the commercialization of the product. Meanwhile, Regeneron will be responsible for the manufacturing and supply of REGN1979 for its development and commercialization within the agreement territory.

Dr. Israel Lowy, Senior Vice President and Head of Oncology Clinical and Translational Science at Regeneron, stated, “Zai Lab is our ideal partner, as their past achievements align closely with our vision. We are committed to leveraging the power of science to continuously deliver innovative therapies to patients suffering from serious diseases. Zai Lab’s support will not only help accelerate the global development of REGN1979 but also enable this promising therapeutic candidate to reach patients in this important region more rapidly.”

Dr. Ying Du, Founder, Chairwoman, and Chief Executive Officer of Zai Lab, stated, “Regeneron is a global leader in innovative drug development. We are pleased to collaborate with Regeneron on REGN1979, thereby establishing Zai Lab’s hematology-oncology product pipeline. Leveraging our expertise in regulatory affairs and clinical development, along with our commercial footprint across Mainland China, Hong Kong, Taiwan, and Macau, Zai Lab aims to drive the success of REGN1979. We will work closely with Regeneron to expand its global business and deliver innovative therapies to patients with unmet medical needs.”

REGN1979 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). REGN1979 is currently being evaluated in a Phase 1 clinical study and a Phase 2 clinical study, which may serve as a registrational trial, in patients with advanced follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and other lymphomas. Positive results from the Phase 1 clinical study of REGN1979 were presented at the 2019 American Society of Hematology (ASH) Annual Meeting.

About Regeneron’s Bispecific Antibody Platform

All bispecific antibodies designed by Regeneron resemble natural human antibodies and can bind to two distinct targets. They are derived from Regeneron’s proprietary next-generation VelocImmune® technology, which utilizes a proprietary genetically engineered mouse platform with a humanized immune system to generate optimized fully human antibodies, followed by further engineering of the corresponding antibodies using the company’s Veloci-Bi® platform. These technology platforms enable the creation of bispecific antibodies without linkers or artificial sequences. Furthermore, the production method for Regeneron’s bispecific antibodies is similar to that of human antibody drugs, exhibiting pharmacokinetic properties comparable to those of human antibody therapeutics.

VelocImmune has been used to develop multiple antibodies, including Dupixent® (dupilumab), Praluent® (alirocumab), Libtayo® (cemiplimab-rwlc), and Kevzara® (sarilumab), which have been approved in numerous countries worldwide. Regeneron previously utilized this technology to rapidly develop a therapeutic treatment for the Ebola virus, which is currently under review by the FDA. Furthermore, this technology is now being applied to the research and development of preventive and therapeutic agents for COVID-19.

Currently, up to six Regeneron bispecific antibodies under development are undergoing clinical studies for various hematologic malignancies and solid tumors. These bispecific antibodies are currently categorized into three classes:

CD3 Bispecific Antibodies: Designed to bridge T cells and tumor cells. At the tumor site, they activate T cells via their CD3 receptors and promote T cell-mediated killing of cancer cells. Investigational candidates include:

CD20xCD3 (REGN1979), for non-Hodgkin B-cell lymphoma;

Two distinct BCMAxCD3 bispecific antibodies (REGN5458 and REGN5459) for multiple myeloma;

MUC16xCD3 (REGN4018) for Ovarian Cancer

CD28 Co-stimulatory Bispecific Antibodies: Designed to bridge T cells and tumor cells. At the tumor site, they co-stimulate T cells via the CD28 receptor and may exert synergistic effects with PD-1 inhibitors and/or CD3 bispecific agents. Investigational candidates include:

PSMAxCD28 (REGN5678), in combination with Libtayo, for prostate cancer.

Tumor-Targeting Bispecific Antibodies: Designed to target proteins exclusively on cancer cells, thereby modulating various signaling pathways to impair cancer cell survival and proliferation. Investigational candidates include:

METxMET (REGN5093), for non-small cell lung cancer driven by MET mutations and/or amplification. REGN5093 targets two distinct regions of the MET receptor on cancer cells to degrade the receptor and block its ability to trigger cell proliferation.

Current Status of B-Cell Non-Hodgkin Lymphoma (B-NHL) Treatment in China

Non-Hodgkin Lymphoma (NHL) encompasses a diverse group of cancers originating from B lymphocytes, T lymphocytes, and natural killer (NK) cells. In 2018, the annual number of new cases and deaths in China exceeded 88,000 and 48,000, respectively. B-cell non-Hodgkin lymphoma (B-NHL) accounts for 85% of all NHL cases, with the two most common subtypes being diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Diffuse large B-cell lymphoma (DLBCL) is a highly aggressive form of B-cell non-Hodgkin lymphoma (B-NHL). Nearly 50% of patients with advanced-stage disease experience disease progression (i.e., relapse or refractoriness) after first-line therapy. For patients with relapsed or refractory (R/R) DLBCL, current treatment options are limited and the prognosis remains poor.

Follicular lymphoma (FL) is a slow-growing (indolent) B-cell non-Hodgkin lymphoma (B-NHL), with most cases diagnosed at an advanced stage. Although the median overall survival for patients with advanced-stage FL ranges from 8 to 15 years, current treatments are not curative, and most patients experience relapse within 5 years regardless of the treatment regimen employed. In certain cases, FL transforms into diffuse large B-cell lymphoma (DLBCL), which is typically managed according to DLBCL treatment protocols.

Responsible Editor: Meng Meng

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