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Harbour BioMed Announces Dosing of First Patient of Batoclimab Phase II Trial in Patients with Thyroid Eye Disease

October 19, 2021

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Harbour BioMed Announces Dosing of First Patient of Batoclimab Phase II Trial in Patients with Thyroid Eye Disease

October 19, 2021

Cambridge, MA, Rotterdam, NL, Suzhou, CN— October 19, 2021


Harbour BioMed (“HBM”, HKEX: 02142) announced that, the clinical trial of its anti-FcRn antibody, batoclimab (HBM9161), has completed the first dosing of first patient in phase II trial for the treatment of thyroid eye disease (TED). This clinical study aims to assess the efficacy and safety of batoclimab in patients with TED in China.


HBM is developing batoclimab as a pipeline in a product to treat multiple pathogenic-IgG mediated autoimmune diseases with significant unmet medical needs. TED is among the first wave of such multiple indications for which HBM is developing drug candidates in China.


“TED may severely impact the quality of life. However, current treatments are unsatisfactory and very limited, relying mainly on high doses of corticosteroids with limited efficacy and severe side effects, especially for clinical symptoms such as proptosis and strabismus, which can result in serious long-term consequences. HBM’s clinical research of batoclimab is bringing new hope for TED treatment, which directly targets the pathogenesis of TED.” said Dr. Xiaoxiang Chen, Chief Development Officer of Harbour BioMed.



About Batoclimab (HBM9161)


Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. Phase 2 study in myasthenia gravis showed that batoclimab can quickly and significantly alleviate patients’ symptoms and improve quality of life. Earlier studies demonstrated that batoclimab is well tolerated​ and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases. HBM licensed batoclimab (HBM9161) from HanAll Biopharma and has the right to develop, manufacture and commercialize in Greater China (including Hong Kong, Macau and Taiwan).


About Thyroid Eye Disease 


Thyroid eye disease (TED), also called Graves' ophthalmopathy (GO) and thyroid- associated ophthalmopathy (TAO), is the major extrathyroidal manifestation of Graves’ disease (GD), and may less frequently occur in patients with chronic autoimmune thyroiditis. Clinical features of TED include swelling and redness of the lids and conjunctiva, eyelid retraction, bulging of the eyes (proptosis or exophthalmos), and misalignment of the eyes with double vision. Impairment or loss of vision can be found in the severe form of TED, secondary to compressive optic neuropathy or corneal defects (including exposure keratopathy and ulceration). Orbital decompression or other ophthalmic surgeries may be considered in sight-threatening cases.


In moderate-to-severe active TED, which has sufficient impact on patients’ daily life but not sight-threatening, intravenous high-dose corticosteroids are considered the main treatment option. However, corticosteroids do not reverse the underlying long-term alteration of orbital tissues measured as improvement in proptosis or strabismus. Furthermore, they often have substantial side effects. Second-line immunosuppressive therapies such as rituximab and tocilizumab have limitations in terms of side effects, pricing, and availability, etc. Significant unmet needs still exist for moderate-to-severe active TED treatment.



About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.
The Company’s proprietary antibody technology platforms Harbour Mice® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.  


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