Hinge Bio has secured a significant partnership with Kyorin Pharmaceutical Co., Ltd. for the development and commercialization of its lead autoimmune therapeutic HB2198 in Japan, marking a major milestone for the biotechnology company's proprietary GEM-DIMER platform technology.
Strategic Partnership Details
Under the collaboration agreement announced on September 30, 2025, Hinge Bio will receive a $10 million upfront payment and is eligible for up to $95 million in milestone payments specifically for the systemic lupus erythematosus (SLE) indication, with additional payments available for other autoimmune indications. The deal structure includes Kyorin funding development, regulatory, marketing and commercialization activities in Japan while contributing to global development efforts.
"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."
The companies have established a Joint Steering Committee to accelerate and potentially expand HB2198 development for treating multiple B cell-mediated autoimmune disorders, with Hinge Bio maintaining leadership of global development activities.
Novel Therapeutic Mechanism
HB2198 represents an innovative approach to treating B cell-mediated autoimmune disorders through its dual-targeting mechanism. The multispecific antibody-based therapeutic targets both CD19 and CD20 with enhanced natural killer cell engagement, a design enabled by Hinge Bio's proprietary GEM-DIMER platform.
Preclinical in vivo studies have demonstrated that HB2198 achieves deeper and more rapid B cell depletion than has been reported for other antibody-based therapies. The therapeutic has shown the ability to rapidly and deeply deplete more than 99% of B cells, representing a significant advancement in the field.
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, while offering the convenience, accessibility, cost and safety benefits of an off-the-shelf antibody-based therapeutic.
Clinical Development Timeline
Hinge Bio anticipates that HB2198 will enter clinical development during the second half of 2025, with the initial focus on treating SLE. The program's development strategy encompasses multiple B cell-mediated autoimmune disorders, positioning it as a platform therapy for various conditions in this therapeutic area.
"Our company is focused on autoimmune disorders as one of our key strategic therapeutic areas for research and development," said Yutaka Ogihara, President and CEO of Kyorin Pharmaceutical Co., Ltd. "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."
Technology Platform Advantages
The GEM-DIMER technology platform enables the creation of multivalent, multispecific antibody-based therapeutics designed to bind their targets cooperatively, allowing for dramatically enhanced biological activity and unique functionality. This platform approach addresses key challenges in current treatments, including inadequate efficacy, resistance, and side effects across autoimmunity, inflammatory disease, and cancer applications.
Hinge Bio's focus on autoimmune disease represents the initial application of this platform technology, with the company advancing a pipeline of programs designed to overcome the limitations of existing therapeutic approaches in this challenging therapeutic area.
