Biopharmaceutical company HanAll Biopharma Co Ltd stated on Monday that it plans to develop, manufacture and commercialise its two novel biologics HL161 and HL036 for dry eye and inflammatory ocular diseases in Greater China (including Hong Kong, Macau and Taiwan), under a collaboration and license agreement with Harbour BioMed.
Under the terms of the agreement, HanAll will receive up to USD81m in total upfront, development, registration, and sales milestones, as well as royalties on net sales. The rights outside of Greater China are reserved for HanAll. Additional terms were not disclosed.
HL161 is a fully human monoclonal antibody targeting neonatal Fc receptor (FcRn). The FcRn rescues IgGs from intracellular degradation and maintains the high serum levels, even pathogenic auto-IgGs. Blocking the FcRn-IgG interaction accelerates the degradation of autoantibodies in pathogenic IgG-mediated autoimmune diseases, including myasthenia gravis, pemphigus, immune thrombocytopenia purpura, neuromyelitis optica, and etc.
Based in South Korea, HanAll discovered HL161 by using transgenic animal producing fully human monoclonal antibodies. It is planning a Phase I clinical study of HL161 in late 2017 as a subcutaneous injectable formulation that differentiates it from the competitors' intravenous formulations.
HL036 is a TNF receptor fragment which has been molecularly engineered to enhance tissue penetration efficiency and TNF-neutralizing potency for the best topical anti-TNF peptide. HanAll has developed the HL036 eye drop for the treatment of dry eye disease (DED) and other inflammatory ocular diseases.
In conjunction, the HL036 eye drop shows no drug-related adverse effects and systemic exposure from Phase I studies in healthy volunteers. HanAll has submitted an Investigational New Drug (IND) application for HL036 to initiate the Phase II clinical study for dry eye disease.
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