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[Financial Performance and Highlights]

HanAll Biopharma(KRX: 009420.KS) today announced that it has recorded 88.3 billion KRW, 6.3 billion KRW, and 21.9 billion KRW in consolidated sales, operating profit, and net profit, respectively, for the year 2020.

As a company that is successfully achieving ‘corporate innovation through R&D’, HanAll Biopharma visualized its R&D performance based on the competitive technological capabilities for new biomedicine development, thus increasing net profit by 14.1% despite a drop in sales by 18.5% with the impact of the COVID-19 pandemic last year.

As of the end of last year, HanAll Biopharma’s assets, equity, and liabilities were 222.7 billion KRW, 185.1 billion KRW, and 37.6 billion KRW, respectively. With a debt ratio of 20.3%, the company is continuing with debt-free management. HanAll Biopharma’s assets increased by 31.3 billion KRW from the previous year as a result of an increase in the value of Immunovant and ImmunoMet, the companies in which it has invested.

[Updates of New Drug Pipeline Development]

- HL161(A Novel anti-FcRn Antibody Drug for Autoimmune Diseases)

For the ‘HL161 novel antibody drug for autoimmune diseases’, which is differentiated as a self-administered subcutaneous injection product, Immunovant, HanAll Biopharma’s global partner, is conducting a Phase 2 clinical trial in a number of countries including the U.S. in three rare autoimmune diseases(myasthenia gravis, thyroid eye disease, and warm antibody hemolytic anemia). Starting with a global Phase 3 clinical trial for myasthenia gravis in the first half of this year, pivotal studies to obtain a permit for each disease will be promoted sequentially.

In addition, with three indications added, a clinical trial for a total of six intractable autoimmune diseases will be conducted by August of this year.

The Phase 2 clinical trial results for warm antibody hemolytic anemia and the Phase 2b clinical trial results for thyroid eye disease will be announced in the second and third quarters of this year, respectively.

In China, Harbour BioMed, HanAll Biopharma’s Chinese partner, is conducting Phase 2 clinical trials on HL161 for patients of rare autoimmune diseases such as neuromyelitis optica, thrombocytopenia, thyroid optic neuropathy, and myasthenia gravis. The clinical results for neuromyelitis optica are reportedly set to be announced during the first half of the year.

- HL036(A novel, topical anti-TNF biologic for Dry eye disease)

For HL036, a novel biologic drug for dry eye disease that is being jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, the Phase 3-2 clinical development strategy will be finalized through the Type C Meeting with the FDA sometime in January. Separately, in China, Harbour BioMed has commenced Phase 3 clinical trials for dry eye disease to obtain the permit for HL036.

- HL186/HL187(Novel Antibody Drug for Cancer Immunotherapy)

Over the past three years, HanAll Biopharma has been implementing its HL186 and HL187 immunotherapeutic antibody projects, with new targets other than PD-1 and PD-L1, jointly with Daewoong Pharmaceutical. It is now at the stage of final antibody derivation through animal model testing. With the antibody derived, HanAll Biopharma will conduct preclinical trials this year.

- HL189(Novel biologic drug for Non-infectious Uveitis)

The drug effect has been verified through animal testing for the HL189 project, which is to treat non-infectious uveitis through intravitreal injection of tanfanercept, the principal component of the HL036 eye drop. It is currently in the preparation stage for clinical trials for patients.