On September 30, 2025 KYORIN Pharmaceutical Co., Ltd. reported that it has entered into an exclusive license agreement with Hinge Bio Inc. (BURLINGAME, CA, CEO：Harold E. "Barry" Selick, "Hinge Bio") on September 30, 2025, for HB2198, new drug candidate for systemic lupus erythematosus (SLE), discovered by Hinge Bio (Press release, Kyorin, SEP 30, 2025, View Source [SID1234656345]).
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Under the terms of this agreement, KYORIN has obtained the exclusive rights in Japan to develop and commercialize HB2198 for the treatment of SLE and other diseases. KYORIN will make an upfront payment of USD 10 million to Hinge Bio. Hinge Bio is also eligible to receive milestone payments of up to USD 95 million for the SLE indication upon the progress of development, approval and the achievement of certain net sales. For indications other than SLE, and separate payment will be made. In addition, royalties based on net sales will be provided to Hinge Bio, and KYORIN will bear a portion of the clinical development costs incurred by Hinge Bio.
Autoimmune diseases such as SLE are caused by an aberrant immune system that mistakenly identifies the body’s own tissues as foreign, leading to excessive immune responses that cause chronic inflammation and organ damage. Many patients cannot get their symptoms under control with existing treatments and suffer from conditions such as joint pain, skin problems, kidney damage, and central nervous system issues.
HB2198 is a humanized bispecific antibody discovered using Hinge Bio’s proprietary GEM-DIMER technology platform. It aims to "reset" the immune system by simultaneously targeting both CD19 and CD20 molecules on the surface of B cells, which play a major role in the development of autoimmune diseases, and by rapidly and deeply depleting B cells in both the circulating blood and lymphoid tissues. Preclinical in vivo studies have demonstrated HB2198’s deep and rapid B cell depletion activity, and it is expected to provide an excellent new treatment option for patients suffering from autoimmune diseases. A Phase 1 clinical trial for patients with SLE is currently being prepared in the United States.
KYORIN aims to create high-value new drugs that meet medical needs and has prioritized "Expand development pipeline" under its medium-term business plan "Vision 110 —Stage1—". With this agreement, we are committed to advancing the development of new treatment options for patients as soon as possible, contributing to people’s health.
The impact on the consolidated earnings forecast for the fiscal year ending March 2026 is expected to include the upfront payment to Hinge Bio under this agreement, which will be recorded as SG&A expenses (R&D expenses) for the current fiscal year.