Hinge Bio Announces License and Collaboration with Kyorin Pharmaceutical Co., Ltd. for the Development and Commercialization of HB2198 in Japan for Autoimmune Diseases
Hinge Bio to receive $10 million upfront and is eligible to receive $95 million for the SLE indication and additional payments for other indications; includes contingent R&D investment, tiered sales royalties, and a portion of investment to global development.
BURLINGAME, Calif. and TOKYO, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Hinge Bio, Inc., a privately-held biotechnology company engaged in the discovery and development of innovative medicines, announced it has entered into a collaboration and license agreement with Kyorin Pharmaceutical Co., Ltd (“Kyorin”) for development of Hinge Bio’s multispecific antibody-based therapeutic HB2198 in Japan for multiple autoimmune indications, starting with Systemic Lupus Erythematosus (“SLE”).
Per the terms of the agreement, Hinge Bio is to receive a $10 million upfront payment, is eligible to receive up to $95 million in milestone payments for the SLE indication, additional payments for other indications, and will lead global HB2198 development activities. Kyorin will fund development, regulatory, marketing and commercialization activities in Japan and contribute a portion of investment to global development. The companies have established a Joint Steering Committee (JSC) to accelerate and potentially widen the development of HB2198 to treat multiple B cell mediated autoimmune disorders.
“Hinge Bio is committed to developing life-changing medicines for patients with intractable diseases, driven by our proprietary GEM-DIMER platform,” said Chief Executive Officer Barry Selick, Ph.D. “We are thrilled to establish this validating collaboration with Kyorin to accelerate and broaden development of HB2198 in Japan for multiple autoimmune indications, beginning with SLE.”
“Our company is focused on autoimmune disorders as one of our key strategic therapeutic areas for research and development. We anticipate that this innovative treatment candidate, developed through our collaboration with Hinge Bio, will offer a new therapeutic option for patients suffering from autoimmune disorders,” said Yutaka Ogihara, President and CEO of KYORIN Pharmaceutical Co., Ltd.
Hinge Bio’s lead candidate from its GEM-DIMER™ platform, HB2198, is expected to enter clinical development during 2H 2025. The program seeks to treat B cell-mediated autoimmune disorders by targeting both CD19 and CD20 with enhanced natural killer cell engagement. Pre-clinical in vivo studies have demonstrated deeper and more rapid B cell depletion than has been reported for other antibody-based therapies. The therapeutic goal of HB2198 is to achieve a reset of the immune system through rapid and deep B cell depletion in both circulating blood and lymphoid tissues, with the convenience, accessibility, cost and safety benefits of an off-the-shelf antibody-based therapeutic.
About HB2198
Hinge Bio’s lead program HB2198, from its proprietary GEM-DIMER™ platform, is designed to improve efficacy, safety, and convenience for the treatment of B cell-mediated autoimmune disorders, such as SLE. HB2198 has demonstrated in vivo proof of concept to rapidly and deeply (>99%) deplete of B cells. The therapeutic goal of HB2198 is to achieve a “reset” of the immune system through rapid and deep B cell depletion in both circulating blood and lymphoid tissues, without the challenges and toxicities associated with current treatments. Hinge Bio anticipates opening a clinical trial in 2H 2025 to first treat SLE.
About Hinge Bio
Hinge Bio, Inc. is a privately held development-stage biotechnology company leveraging its proprietary GEM-DIMER™ platform to design and develop the next generation of therapeutics leading to address the problems of inadequate efficacy, resistance, and side effects in the fields of autoimmunity, inflammatory disease, cancer, and other disease. The GEM-DIMER™ technology platform enables the creation of multivalent, multispecific antibody-based therapeutics that are designed to bind their targets cooperatively allowing for dramatically enhanced biological activity and unique functionality. Hinge Bio is advancing a pipeline of programs with an initial focus on autoimmune disease.
About Kyorin
KYORIN operates under the corporate philosophy, "KYORIN continues to fulfil its mission of cherishing life and benefiting society by contributing to better health." Based on this principle, we aim to continuously provide high-value new drugs that meet medical needs, striving to become a company that contributes broadly to people's health. In drug discovery, we focus our research efforts on the therapeutic areas of pain and autoimmune disorders etc., working to create innovative new drugs that meet significant medical needs.
For more information, please visit https://www.kyorin-pharm.co.jp/en/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, include statements regarding the potential therapeutic benefits and applications of our product candidates; our ability to successfully advance our product candidates, undertake certain development activities (such as the initiation of clinical trials, clinical trial enrollment, the conduct of clinical trials and the announcement of top-line results) and accomplish certain development goals, and the timing of such events; the potential benefits of our collaboration with Kyorin; and the scope and strength of our intellectual property portfolio. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our product candidates, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the fact that our collaboration with Kyorin is subject to early termination in certain circumstances, the possibility of unexpected expenses or other demands on our cash resources, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Meru Advisors on Behalf of Hinge Bio:
Patrick Till
ptill@meruadvisors.com or info@hingebio.com
Learn more at www.hingebio.com
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