Kyorin Expands Autoimmune Portfolio with Hinge Bio Deal
Kyorin Pharmaceutical has expanded its autoimmune portfolio by entering into a collaboration and license agreement with Hinge Bio for the Japanese rights to the biotech’s preclinical lupus drug, HB2198. The agreement includes an upfront payment of $10 million, with the potential for milestone payments of up to $95 million for systemic lupus erythematosus (SLE) and additional payments linked to other autoimmune indications.
Innovative B-Cell Depletion Therapy
HB2198, developed by California-based Hinge Bio, is designed to target both CD19 and CD20 for B-cell depletion. The therapy was created using Hinge’s GEM-DIMER multivalent antibody platform. According to Hinge, the program is expected to enter clinical development in the second half of 2025. The therapeutic candidate is aimed at treating B-cell-mediated autoimmune disorders by achieving what the company describes as a reset of the immune system, combining deep and rapid B-cell depletion with the accessibility and safety benefits of an off-the-shelf antibody-based therapy.
Promising Preclinical Data
Preclinical data released by Hinge last year showed that HB2198 achieved deeper and more rapid B-cell depletion than has been reported for other antibody-based therapies. The company has indicated that the approach could enable broader treatment options across multiple autoimmune conditions beyond lupus.
Deal Structure and Collaboration
As part of the deal, Kyorin will fund development, regulatory, marketing, and commercialization activities in Japan, while also contributing to the global development of HB2198. The two companies have also formed a Joint Steering Committee to oversee and potentially accelerate the program’s progress into additional autoimmune indications.
Executive Commentary
In a statement announcing the collaboration, Kyorin’s President and CEO, Yutaka Ogihara, said, “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.”
Hinge Bio’s Chief Executive Officer, Barry Selick, also commented on the agreement, noting that the collaboration with Kyorin would help expand the development of HB2198 in Japan for SLE and other autoimmune conditions. He described the program as a key example of Hinge’s GEM-DIMER platform driving the creation of antibody-based therapeutics for patients with intractable diseases.
Kyorin’s Growing Pipeline
For Kyorin, the partnership with Hinge adds another asset to its growing pipeline in specialty areas. The company is currently advancing a phase 3-stage pulmonary sarcoidosis drug licensed from aTyr Pharma and a phase 1-stage beta 3 adrenergic receptor agonist for overactive bladder acquired from Merck & Co. In December 2024, Kyorin acquired worldwide rights to Bayer’s ADRA2C antagonist, which had completed a phase 1 trial for sleep apnea, in a deal valued at 15 million euros ($17.6 million). The company has also drawn interest from European partners, with Novartis securing rights to its MRGPRX2 antagonist in a $55 million upfront deal earlier this year.
Global Development Outlook
Under the latest collaboration, Hinge Bio will lead global development activities for HB2198 while remaining eligible for milestone payments and tiered sales royalties. Kyorin’s involvement is expected to advance development of the therapy within Japan while supporting the broader global program.
Additional Insights & Future Directions
With the Kyorin-Hinge Bio agreement in place, several future considerations emerge:
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Regulatory Path in Japan: Kyorin will need to work closely with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to align requirements for clinical trial designs, safety monitoring, and post-marketing commitments.
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Expanding Indications: Although the primary focus is on SLE, HB2198’s mechanism suggests potential in related autoimmune conditions (e.g. rheumatoid arthritis, Sjögren’s syndrome). Kyorin may invest in exploratory studies for these.
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Manufacturing & Safety Scaling: Off-the-shelf antibody therapies bring challenges in scaling up production, ensuring consistent safety, especially for deep B-cell depletion. Kyorin’s experience with biologics will be critical.
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Competitive Landscape: Kyorin will face competition from existing B-cell depletion treatments and newer modalities. Differentiation around speed, depth of depletion, safety, and cost will define success.
This deal not only adds HB2198 to Kyorin’s portfolio but also signals a shift towards more aggressive in-licensing and global collaboration for autoimmunity. It’s a clear indication that Kyorin sees antibody-based, deep B-cell depletion therapies as key to the next generation of autoimmune treatments.
