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- Full-year 2025 net revenue reaches 155 billion KRW, driven by double-digit growth in pharmaceutical sales.

- R&D momentum remained strong, supported by positive clinical results and multi-indication expansion of anti-FcRn assets.

- Five data readouts expected in 2026 across three core assets, reinforcing HanAll's position as an innovative global biopharma company.

HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for 2025 and provided business highlights.

Total revenues for 2025 reached 155 billion Korean won (KRW), primarily driven by strong sales growth from key products. Operating profit reflected higher SG&A expenses during the period, resulting in weaker profitability.

Pharmaceutical sales recorded 133 billion KRW, delivering 13% year-over-year growth, supported by a focused portfolio across key therapeutic areas—probiotics, hair loss, and urology-all maintaining steady sales growth in their respective categories. This reflects HanAll’s continued focus on core strengths and disciplined execution since 2023, resulting in three consecutive years of double-digit growth.

R&D momentum continued, with clinical data underscoring the strong potential of R&D programs. Batoclimab, an anti-FcRn therapy being developed for autoimmune diseases, reported clinically meaningful results in the Phase 3 study of myasthenia gravis (MG) and Phase 2b study of Chronic inflammatory demyelinating polyneuropathy (CIDP). Batoclimab also provided evidence of durable disease-modifying potential through six-month off-treatment data from a Phase 2 proof-of-concept study in Graves’ disease (GD).

Meanwhile, the next-generation anti-FcRn asset HL161ANS (IMVT-1402) progressed into potentially registrational studies in five indications- GD, MG, CIDP, Difficult-to-treat Rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD) and a proof-of-concept study in Cutaneous lupus erythematosus (CLE).

Efforts to strengthen corporate governance and operational integrity continued in 2025, resulting in the successful renewal of ISO 37001 anti-bribery certification. HanAll also received government recognition for R&D excellence, including the National Industry Award in R&D and a ministerial commendation from the Ministry of Trade, Industry and Resources (MOTIR).

Looking ahead to 2026, HanAll anticipates multiple key clinical readouts, including batoclimab Phase 3 studies in thyroid eye disease (TED), HL161ANS registrational study in D2T RA, proof-of-concept study in CLE, and tanfanercept VELOS-4 Phase 3 study in dry eye disease (DED). The company also plans to initiate first-in-patient study of HL192 (ATH-399A) in Parkinson’s disease (PD).

“2025 was a year in which HanAll achieved steady growth in its pharmaceutical business while continuing to build meaningful clinical momentum across our pipeline. 2026 is expected to mark a pivotal year for HanAll, with five global clinical readouts anticipated across three assets supporting our continued progress in becoming a globally respected biopharma,” said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.

■ Pipeline Overview

FINANCIAL HIGHLIGHTS (CONSOLIDATED) 

Key Highlights 

* (KRW in billion)

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs.

For over 50 years, HanAll has maintained a portfolio of pharmaceutical products in the endocrine, circulatory, and urologic therapeutic areas. The company has expanded its focus to immunology, oncology, neurology, and ophthalmology, advancing a late-stage pipeline of novel therapies for diseases with limited treatment options.

Key pipeline assets include HL161 (batoclimab and HL161ANS), anti-FcRn antibodies in late-stage development for a range of autoimmune diseases; tanfanercept (HL036), a TNF inhibitor protein in Phase 3 development for dry eye disease (DED); and HL192 (ATH-399A), a Nurr1 activator targeting Parkinson’s disease.

For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).

Disclaimer Statement 

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2026 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.