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[Sales Performance and Financial Conditions]

HanAll Biopharma(KRX: 009420.KS) today announced on the 29th that it recorded 22.1 billion KRW, 1 billion KRW, and 3.7 billion KRW in consolidated sales, operating profit, and net profit respectively for the third quarter of 2020.

The company’s total sales, operating profit, and net profit for the third quarter of 2020 are 66.8 billion KRW, 5.5 billion KRW, and 13.5 billion KRW, respectively.

HanAll Biopharma is sustaining a stable financial condition with assets, capital, and liabilities of 207.3 billion KRW, 168.1 billion KRW, and 39.2 billion KRW, respectively, as of the end of the third quarter.

[Status 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 Phase 2 clinical trials in several countries including the U.S. in relation to three rare autoimmune diseases(myasthenia gravis, thyroid eye disease, and warm antibody hemolytic anemia). In August, Immunovant announced the Phase 2 clinical trial top-line results for myasthenia gravis. As HL161 displayed an effect of improvement for symptoms and safety higher than those of the placebo, the potential for its new drug permit has increased. The final Phase 3 clinical trials for the permit are scheduled to commence during the first half of next 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 first quarter and the first half of next year, respectively. Immunovant also announced that it will conduct clinical trials in relation to a total of six autoimmune diseases by adding three indicators for HL161.

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. In addition, it announced the commencement of patient administration for the Phase 2 clinical trials in relation to myasthenia gravis and thrombocytopenia in September.

- HL036(A Novel, Topical anti-TNF Biologic for Dry eye disease)

For the HL036 novel biologic drug for dry eye disease that is being jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, the Type C meeting with the FDA has commenced, and the clinical development strategy will be finalized through this meeting. Separately, in China, Harbour BioMed commenced the Phase 3 clinical trials for dry eye disease to obtain the permit for HL036, and plans to begin patient administration in the fourth quarter.

- HL186/HL187(A Novel Immune-oncology Drug Drug for Cancer Immunotherapy)

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

- HL189(A novel anti-TNF Biologic 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.