South Korean company, HanAll Biopharma reported an 11% year-on-year increase in Q3 2023 revenue, reaching KRW 33 billion. The company attributed this growth to robust sales from pharmaceutical products such as 'Normix', 'Eligard', and 'BioTop'. The net profit for the quarter was KRW 300 million with an operation income of KRW 100 million.
In the field of research and development, HanAll has been making strides with several pipeline developments. The company's HL161ANS showed potential in Phase 1 trials as an anti-FcRn asset for IgG-mediated autoimmune diseases. HL192, developed in collaboration with Daewoong Pharmaceutical and NurrOn Pharmaceuticals, is aimed at treating Parkinson's Disease (PD). The initial results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024.
In addition to these developments, HanAll is anticipating Phase 2 results for batoclimab in Graves' disease and multiple ascending dose (MAD) study results for HL161ANS 600 mg in Q4 2023. The Biologics License Application (BLA) for batoclimab in treating generalized myasthenia gravis (gMG) was accepted in June 2023 based on positive Phase 3 clinical trial results.
The company has also partnered with Immunovant (NASDAQ:IMVT) to develop a FcRn inhibitor for autoimmune indications including Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Thyroid Eye Disease (TED), with key milestones expected in Q4 2023 and the first half of 2024.
In collaboration with Daewoong Pharmaceutical, HanAll is working on tanfanercept, a treatment for ophthalmic diseases, specifically dry eye disease (DED). The companies plan to discuss the VELOS-4 study design with the FDA based on the completed Phase 3 VELOS-3 study data within the second half of 2023 and commence the next study in 2024.
Lastly, HanAll and Daewoong Pharmaceutical are developing monoclonal antibodies HL187 and HL186, targeting TIGIT (T cell immunoreceptors with Ig and ITIM domains) and TIM-3 respectively, as potential oncology treatments. The companies are currently conducting pre-clinical studies for these treatments. In the MAD portion of the study, HL161ANS achieved a 63% lgG reduction from the baseline, with top-line results from the gMG Phase 3 study expected in the second half of 2024.
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