- Global license agreement to focus on the development of FG-M701, a TL1A antibody, for the treatment of inflammatory bowel disease (IBD)

NORTH CHICAGO, Ill. and BEIJING, June 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and FutureGen Biopharmaceutical (Beijing) Co., Ltd. today announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of IBD currently in preclinical development.

FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation TL1A antibodies with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD.

"The prevalence of IBD continues to increase, and many people living with ulcerative colitis and Crohn's disease do not respond to current therapies," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "AbbVie's mission to raise the standard of care includes the pursuit of transformative therapies that help more patients living with autoimmune diseases achieve remission. We look forward to our collaboration with FutureGen in advancing development of FG-M701 for the treatment of IBD."

"We are very pleased to partner with AbbVie, a world-leader in the development and commercialization of innovative inflammation and autoimmune therapies," said Zhaoyu Jin, Ph.D., founder and chief executive officer, FutureGen Biopharmaceutical (Beijing) Co., Ltd. "We believe that AbbVie is a great partner, with the ability to apply their expertise and global scale to realizing FG-M701's therapeutic potential and rapidly advancing this therapy for patients suffering from IBD. The collaboration with AbbVie also highlights FutureGen's ability to generate potential best-in-class product candidates with our proprietary Structure-based Targeted Evolution Platform (STEP) technology platform."

Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize FG-M701. FutureGen will receive $150 million in upfront and near-term milestone payments and will be eligible to receive up to an additional $1.56 billion in clinical development, regulatory and commercial milestones, as well as tiered royalties up to low-double digits on net sales.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

About FutureGen

FutureGen Biopharmaceutical (Beijing) Co., Ltd. is an innovative biopharmaceutical company committed to providing high-quality innovative biologics for patients with cancer, immune diseases and other diseases. FutureGen has developed the proprietary STEP by integrating structural biology, advanced antibody engineering, and AI technologies to enable highly efficient, rapid and high-throughput drug screening and optimization. FutureGen has utilized STEP to develop CLDN18.2 antibody-dependent cellular cytotoxicity (ADCC) enhanced antibody (FG-M108), a potential best-in-class product with excellent efficacy and superior safety in the first-line treatment of advanced G/GEJ and pancreatic cancer, currently in Phase 3. Additionally, FutureGen possesses several innovative multi-specific antibodies and antibody-drug conjugates (ADC) for immuno-oncology therapy, including a CD40-PDL1 bi-specific antibody in clinical stage. For more information, please visit www.futuregenbiopharm.com.

AbbVie Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie