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- SEOUL, South Korea and SHANGHAI and CAMBRIDGE, Mass., Sept. 12, 2017

HanAll Biopharma Co., Ltd.(009420.KS) and Harbour BioMed announced today that they have entered into a strategic collaboration and license agreement to develop, manufacture and commercialize in Greater China (including Hong Kong, Macau and Taiwan) HanAll\'s two novel biologics, the anti-FcRn monoclonal antibody, HL161, for the treatment of pathogenic IgG-mediated autoimmune diseases, and the anti-TNF ophthalmic solution, HL036, for dry eye and other inflammatory diseases.  

HanAll Biopharma will receive up to $81 million 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.

"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," said Seung Kook Park, PhD, MBA, CEO of HanAll Biopharma. "This collaboration will enable us to accelerate the development and commercialization of our pipeline products in other countries too, especially in the US 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. This collaboration is aligned with our strategy to leverage our global and regional clinical development expertise by in-licensing clinical stage compounds that are complementary to the internal portfolio we are building through our industry leading, transgenic mouse platforms for generating fully human antibodies."

About HL161

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 and alleviates the flare-up in wide array of pathogenic IgG-mediated autoimmune diseases such as myasthenia gravis, pemphigus, immune thrombocytopenia purpura, neuromyelitis optica, and etc. HanAll discovered HL161 by using transgenic animal producing fully human monoclonal antibodies. The company 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.

About HL036

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. The HL036 eye drop shows no drug-related adverse effects and systemic exposure from Phase I studies in healthy volunteers. HanAll submitted an Investigational New Drug (IND) application for HL036 to initiate the Phase II clinical study for dry eye disease in November 2017 in collaboration with Ora Inc in the US. In addition to DED, HanAll is developing a new HL036 formulation for the inflammatory ocular diseases in posterior regions such as diabetic retinopathy and wet age-related macular degeneration, in collaboration with an undisclosed Japanese company.

About HanAll Biopharma

HanAll BioPharma Co., Ltd. (009420.KS), a subsidiary of Daewoong Pharmaceutical Co., Ltd., is a fully integrated biopharmaceutical company based in South Korea focusing on the discovery and development of innovative biological therapeutics in the areas of autoimmune diseases and immuno-oncology. HanAll\'s lead pipeline assets are 1) HL161, a fully human monoclonal antibody targeting neonatal Fc Receptor (FcRn) for the treatment of pathogenic-IgG mediated autoimmune diseases, 2) HL036, anti-TNF ophthalmic solution for the treatment of dry eye diseases, and 3) two novel immuno-oncologic projects. HanAll\'s ambition is to be a leader in the area of immunology providing new therapeutics to patients with severe immune disorders in cooperation with specialized groups in each research field and through open innovation.

About Harbour BioMed

Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer, with a focus on immuno-oncology, and immunological diseases. The company\'s discovery and development programs are built around its two patented transgenic mouse platforms (Harbour Mice) for human antibody discovery. The company is building its proprietary pipeline through its innovative internal discovery programs, and through in-licensing clinical stage assets that strategically fit its internal portfolio. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.