HanAll will receive $81 million, develop the drugs, and have the right to registration and sales milestones, as well as royalties on net sales. HanAll will retain the rights outside of Greater China.
Harbour BioMed will control the market for the drugs in Greater China (including Hong Kong, Macau and Taiwan).
HL161 is an antibody that targets a protein called neonatal Fc receptor (FcRn). HL161 alleviates the flare-up in pathogenic IgG-mediated autoimmune diseases such as myasthenia gravis, pemphigus, immune thrombocytopenia purpura, and neuromyelitis optica. Ig-G is a type of antibody that, in these diseases, is turned against the body’s own cells and tissues.
HL161 targets FcRn, a protein that rescues antibodies from their destruction inside cells, keeping their levels high in the blood. By blocking FcRn, harmful antibodies, called autoantibodies, are destroyed.
A Phase I clinical study of HL161 is planned for late 2017, testing its subcutaneous injectable formulation, which patients can inject themselves, giving it an edge over competitors’ intravenous formulations that must be given by a healthcare professional in an appropriate health facility.
The other drug, HL036, is an eye drop for the treatment of dry eye disease (DED) and other inflammatory diseases of the eye. The HL036 eye drop was shown to be safe in a Phase 1 clinical trial. HanAll submitted an investigational new drug (IND) application for HL036 in preparation for a Phase 2 clinical study for dry eye disease planned for November 2017 in collaboration with Ora Inc. in the U.S.
“We are delighted to be able to work with Harbor BioMed’s team who have demonstrated outstanding capability in the discovery and development and commercialization of novel antibody therapeutics within the immunology field and deep expertise in China,” Seung Kook Park, PhD, CEO of HanAll Biopharma said in a press release. “This collaboration will enable us to accelerate the development and commercialization of our pipeline products in other countries, too, especially in the U.S. and European countries.”
“There are great unmet medical needs that these two innovative compounds can address for Chinese patients,” said Jingsong Wang, MD, PhD, CEO of Harbour BioMed. “We are looking forward to collaborating with HanAll Biopharma to develop them in Greater China.