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HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, has officially notified Harbour BioMed of the termination of the licensing agreement for its autoimmune disease treatment, HL161 (INN: batoclimab), in China. Arbitration proceedings have commenced under the International Chamber of Commerce (ICC).

HanAll Biopharma entered into a licensing agreement with Harbour BioMed in 2017, granting exclusive development and commercialization rights for batoclimab in Greater China, including Taiwan, Hong Kong, and Macau. Batoclimab is a novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Given the complex nature of autoimmune diseases, drug developers typically conduct multiple clinical trials to secure approvals across various indications, to help the broadest group of patients in need.

However, while Harbour BioMed has completed Phase 3 clinical trials and has pursued regulatory approval for generalized myasthenia gravis (gMG), there has been no continuing development progress for other key target indications; for example, thyroid eye disease (TED) is currently in a multinational phase 3 clinical trial, yet Harbour Biomed is not actively studying batoclimab as a potential treatment for these patients in need. HanAll has determined that Harbour BioMed has not met its contractual diligence obligations and failed to make "commercially reasonable efforts," as outlined in the agreement.

On January 26, 2025, HanAll formally notified Harbour BioMed of the contract termination. The arbitration proceedings have commenced under the ICC’s New York office, in accordance with the termination procedures stipulated in the agreement.

A HanAll Biopharma representative stated, “'HanAll is committed to prioritizing patients’ needs by ensuring timely access to effective treatment. We remain open to seeking a resolution through arbitration and will continue our efforts to deliver batoclimab to patients living with incurable diseases in Greater China.”

The contract remain valid until the final decision from the ICC is made.

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