Harbour BioMed (HBM) has recently announced the approval of its IND application for HBM9161 by NMPA (National Medical Products Administration). HBM9161 is a full-human antibody that targets neonatal FcRn (Fc receptor). The approval has been given for conducting the Phase 2/3 clinical trials among GO (Graves’ ophthalmopathy) patients.
HBM9161 has received four IND approvals to date in China, with 2 approvals for this clinical-stage biopharmaceutical company to directly commence the Phase 3 trial under the accelerated development pathway.
According to Dr. Jingsong Wang, M.D., Ph. D[SW1] ., Harbour BioMed’s CEO, Chairman, and Founder, Graves’ ophthalmopathy is a debilitating disease. The recent approval will further the company’s target to offer innovative medicines for GO patients. The company is planning to accelerate the clinical development of HBM9161 in China. The recent approval for clinical trials of HBM9161 among GO patients, alongside rising clinical programs in the region to treat other autoimmune diseases, highlights the ompany’s strategy to create a capable medicinal compound.
Additionally, the monoclonal antibody also has received Investigational New Drug clearances from the NMPA to treat patients with myasthenia gravis, NMOSD (neuromyelitis optica spectrum disorder) and immune thrombocytopenia. The Phase 2 clinical trials of these indications are in progress.
GO, known as Thyroid Eye Disease, is regarded as an autoimmune inflammatory disorder that can lead to the permanent blindness of the patients. Significant unmet medical needs to develop therapeutic solutions are still prevalent due to limited treatment options for serious & disfiguring diseases. HBM9161 can act as a targeted treatment option for GO patients by accelerating the depletion of GO-causing autoantibodies[SW2] .
HBM and HanAll Biopharma formed a license agreement for HBM9161, which offers HBM the right to commercialize, manufacture, and develop the monoclonal antibody in Greater China, including Taiwan, Macau, and Hong Kong. On the other hand, HanAll has the licensed rights to Immunovant in North Africa[SW3] , Middle East, EU, and the Americas. Immunovant revealed positive results of the Phase 2a study of IMVT-1401 in GO patients.