HanAll Biopharma Co., Ltd. (KRX: 009420.KS) has released its financial results for the third quarter of 2024, showcasing an 11.7% increase in revenue, reaching 36.8 billion KRW, and an operating profit of 430 million KRW. The company also provided updates on its key pipeline programs, particularly in autoimmune diseases, ophthalmology, and neurology.
Autoimmune Disease Programs
Batoclimab (HL161BKN), an anti-FcRn antibody, is under development by Immunovant, HanAll’s licensed partner in the United States and Europe, across four autoimmune indications. Phase 3 studies are ongoing for generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED), with topline results expected in the first quarter and first half of 2025, respectively. Immunovant previously reported positive results from a Phase 2a study of batoclimab in Graves’ Disease, demonstrating a 76% response rate in patients inadequately controlled on antithyroid drugs (ATDs) after 12 weeks of treatment; the ATD-free response rate was 56% at the same time point.
For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Immunovant is enrolling subjects in a Phase 2b study. The data will inform the design of a potential registrational program for IMVT-1402 in CIDP, with initial results from the first period of the Phase 2b study expected in the first quarter of 2025.
HL161ANS (IMVT-1402), another anti-FcRn antibody, is also advancing. Immunovant plans to initiate a pivotal study in Graves’ Disease (GD), leveraging findings from the batoclimab Phase 2a study. The results indicated a significant correlation between IgG level reduction and clinical outcomes, suggesting HL161ANS/IMVT-1402 could be a best-in-class treatment option for GD patients. Immunovant intends to initiate 4 to 5 potentially registrational studies for IMVT-1402 before the end of the first quarter of 2025 and plans to commence studies for IMVT-1402 across a total of up to 10 indications by the end of the first quarter of 2026. The company is also exploring initiating a registrational development in gMG with IMVT-1402.
Ophthalmic Disease Program
Tanfanercept (HL036), a TNF inhibitor protein, is being evaluated by HanAll Biopharma and Daewoong Pharmaceutical in the Phase 3 VELOS-4 study for dry eye disease. Topline results are expected in 2026. The VELOS-4 trial builds on insights from the Phase 3 VELOS-3 study, where tanfanercept showed a statistically significant improvement in tear volume, measured by unanesthetized Schirmer testing, at week 8 (p=0.002). A post hoc analysis revealed that 14% of participants in the tanfanercept group showed significant improvement (≥10mm increase from baseline) in the Schirmer test at week 8, compared to only 4% in the vehicle group (p=0.011).
Neurology Program
HL192 (ATH-399A), a Nurr1 activator targeting Parkinson’s Disease, has completed a Phase 1 study in healthy volunteers. The results are expected in November 2024. This program is being developed in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical.
Oncology Programs
HanAll has discontinued its monoclonal antibody programs targeting TIM-3 and TIGIT, following recent data outcomes and decisions from other global companies. The company is exploring the potential for developing a new asset for a different oncology target.
According to Sean Jeong, MD, MBA, CEO of HanAll Biopharma, the company's focus and execution have positioned it for significant growth, enabling continued R&D efforts through strategic cost optimization. HanAll is committed to expanding its competitive advantage by specializing in key products and strengthening its R&D capabilities to realize its potential as a global company.
