AbbVie and RemeGen Announce Exclusive Licensing Agreement to Develop A Novel Bispecific Antibody for Advanced Solid Tumors

-       RC148 is a novel PD-1/VEGF bispecific antibody being evaluated in multiple advanced solid tumors including certain lung cancers

AbbVie (NYSE: ABBV) and RemeGen today announced an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors.

PD-1/VEGF-targeted bispecific antibodies represent a new class of cancer therapies that aim to help the immune system fight tumors more effectively and potentially overcome tumor resistance mechanisms by blocking both PD-1 and VEGF simultaneously. Additionally, given their potential to modulate both immune suppression and foster a favorable tumor microenvironment for antibody-drug conjugate (ADC) activity, PD-1/VEGF bispecific antibodies are also being explored in combination with ADCs. In early clinical studies, RC148 has shown initial favorable antitumor activity in combination with an ADC.

RC148 further strengthens AbbVie's diverse oncology portfolio. In particular, it may offer new opportunities to explore combination regimens with AbbVie's ADCs such as investigational telisotuzumab adizutecan (Temab-A), across multiple solid tumors with high unmet need including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

"Our partnership with RemeGen reflects AbbVie's commitment to not only advance novel oncology treatments, but also to build strong collaborations with biopharmaceutical innovators globally as an increasingly important source of scientific and clinical progress," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "By combining the immune checkpoint inhibition and anti-angiogenic activity of RC148 together with the targeted cytotoxic activity of ADCs, we have the potential to identify meaningful options for patients across a range of solid tumors."

"This collaboration is a significant milestone for RemeGen, highlighting the innovative potential of RC148 in addressing critical unmet medical needs in cancer treatment," said Dr. Jianmin Fang, chief executive officer of RemeGen. "The deal further underscores RemeGen's commitment to bringing cutting-edge therapies to patients worldwide. Working with AbbVie, we look forward to maximizing RC148's clinical and commercial potential in China and globally."

Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize RC148 outside of the Greater China territory. RemeGen will receive an upfront payment of USD $650 million and is eligible to receive up to USD $4.95 billion in aggregate development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales outside the Greater China territory.

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 including 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 AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

About RemeGen
RemeGen Co., Ltd. is a leading innovative biopharmaceutical company in China focused on the discovery, development, manufacturing and commercialization of proprietary biologics. The company is dual-listed on the Hong Kong Stock Exchange and the STAR Market of the Shanghai Stock Exchange.

RemeGen has built a highly differentiated pipeline across autoimmune, oncology and ophthalmology, with a proven ability to rapidly translate innovative science into clinically and commercially meaningful medicines. Its two flagship products, telitacicept and disitamab vedotin, have received approvals for a total of six indications in China, underscoring RemeGen's strong capabilities in first-/best-in-class biologics discovery, efficient clinical execution and successful commercialization. Additional information is available on the company's website at https://www.remegen.com/

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, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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. 

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SOURCE AbbVie