Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves’ Ophthalmopathy

HBM9161 Receives Its Fourth IND Approval for Clinical Trials in China

CAMBRIDGE, Mass. & ROTTERDAM, The Netherlands & SUZHOU, China–(BUSINESS WIRE)–Harbour BioMed (HBM) today announced that National Medical Products Administration (NMPA, China) approved its IND application for HBM9161, a full-human antibody targeting neonatal Fc receptor (FcRn), to conduct a Phase 2/3 clinical trial in patients with Graves’ ophthalmopathy (GO). The IND approval is the fourth for HBM9161 in China and the second to allow the Company to proceed directly to Phase 3 under an accelerated development pathway.

“GO is an extremely debilitating disease and with this IND we further our commitment to bringing innovative medicines to patients,” said Dr. Jingsong Wang, M.D., Ph.D., Founder, Chairman and CEO of Harbour BioMed. “We look forward to accelerating HBM9161’s clinical development in China. The approval to conduct clinical trials with HBM 9161 in GO, along with the emerging clinical programs in China for other autoimmune diseases, underscores the potential our strategy to develop this promising compound as a ‘portfolio in a product’.”

HBM9161 has also received IND clearances from NMPA to treat myasthenia gravis, neuromyelitis optica spectrum disorder (NMOSD) and immune thrombocytopenia. Phase 2 studies in all of these indications are getting under way.

Graves’ ophthalmopathy, also known as Thyroid Eye Disease, is an autoimmune inflammatory disorder which may result in permanent blindness. With limited treatment options currently available against this serious and disfiguring disease, there is still a significant unmet medical need to bring therapeutic solutions for patients. By accelerating the depletion of autoantibodies that cause GO, HBM9161 may offer a targeted treatment option for patients.

HBM licensed HBM9161 from HanAll Biopharma and has rights to develop, manufacture and commercialize the antibody in Greater China (including Hong Kong, Macau and Taiwan). HanAll has licensed rights to the antibody to Immunovant for the Americas, European Union, Middle East and North Africa. In March, Immunovant announced positive initial results of a Phase 2a proof-of-concept study of the drug (IMVT-1401) in GO.

About HBM9161

HBM9161 is an antibody targeting the neonatal Fc receptor (FcRn). FcRn expression extends the half-life of IgGs and serum albumin by reducing lysosomal degradation in endothelial cells and bone-marrow derived cells. Blocking the FcRn-IgG interaction accelerates the degradation of autoantibodies and alleviates flare-ups in preclinical models of wide array of pathogenic IgG-mediated autoimmune diseases, including myasthenia gravis, Grave’s ophthalmopathy, neuromyelitis optica spectrum disorder and immune thrombocytopenia amongst others. Harbour BioMed conducted its first anti-FcRn proof-of-concept clinical study earlier this year, for the treatment of NMOSD.

About Graves’ Ophthalmopathy (GO)

Graves’ ophthalmopathy, is a problem that develops in people with an overactive thyroid caused by Graves’ disease, which may result in permanent blindness. Currently, there is lack of adequate effective and safe treatment, acute relapses are mainly treated with large doses of glucocorticoid. However, there are safety problems and the long-term course of the disease cannot be effectively reversed or changed. The disability caused by activity needs to be improved by surgery after the disease.

About Harbour BioMed

Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and immunological diseases. The Company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.

The Company’s internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies, heavy chain only antibodies (HCAb) and HCAb based bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China. For more information, please visit www.harbourbiomed.com

Contacts

Atul Deshpande PhD, MBA

Chief Strategy Officer and Head, US Ops.

Harbour BioMed

Phone: +1-908-210-3347

E-mail: atul.deshpande@harbourbiomed.com