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- Full-year 2023 net revenue reaches 135 billion KRW, driven by strong sales growth.
- R&D momentum persisted with promising
developments in anti-FcRn antibodies HL161ANS and batoclimab, positioning them
as potentially best-in-class treatments for lgG-mediated autoimmune diseases.
- Anticipates the initiation of tanfanercept
Phase 3 VELOS-4 study in dry eye disease in the first half of 2024 and top-line
data results from HL192 Phase 1 study for Parkinson’s Disease in the second
half of 2024.
ROCKVILLE, Md. and SEOUL, South Korea, March 21, 2024
HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for 2023 and provided business updates.
HanAll delivered a strong full-year performance, with a 23 percent increase in sales compared to 2022, demonstrating continued innovation momentum through multiple meaningful data readouts for anti-FcRn assets and the dry eye disease program.
Total revenues for 2023 were 135 billion Korean won (KRW), mainly driven by strong sales growth from key products. Operating income for the year recorded 2.2 billion KRW.
“As we
anticipate further advancements in 2024, including the VELOS-4 study in dry eye
and additional data readouts from the anti-FcRn assets and Parkinson’s program,
we will continue to focus our efforts to serve patients,” he added.
Full-Year 2023 BUSINESS
UPDATE
Pipeline Development
Highlights
A
comprehensive update of HanAll’s pipeline development below includes an overview
of research along with lists of compounds, targeted indications, and
developmental phases.
AUTOIMMUNE DISEASES
PROGRAMS
Batoclimab (HL161BKN)
A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies.
º Immunovant, HanAll’s licensed partner in the United States and Europe, has reported positive initial results from a Phase 2 proof-of-concept trial evaluating the safety and efficacy of batoclimab in patients with Graves’ disease. The study demonstrated that batoclimab achieved response rates exceeding 50% in patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks. Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose. Consistent with studies of batoclimab in other indications, the subcutaneous administration of 680 mg batoclimab showed an impressive reduction of up to 87% in IgG levels, with a mean IgG reduction of 81% after 12 weeks of treatment. Batoclimab was generally well tolerated with no new safety signals identified from the initial data set. Immunovant plans to assess the development of the second anti-FcRn, ‘HL161ANS (IMVT-1402)’, for Graves’ disease, with details expected to be unveiled later in 2024.
º Harbour BioMed, a licensed partner in China, provided updates on the progress of the Biologics License Application (BLA) submission for batoclimab, intended for the treatment of generalized myasthenia gravis (gMG). In line with the clinical study protocol, the company is currently in the extension period of the Phase 3 clinical trial to gather additional long-term safety data. Harbour BioMed plans to include the supplementary long-term safety data and aims to re-submit the BLA for batoclimab to the National Medical Products Administration (NMPA) in the first half of 2024. BLA submission for batoclimab for the treatment of gMG was made in June 2023, prompted by a positive topline result obtained from the Phase 3 clinical trial.
º HanAll and Immunovant are progressing a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan. Clinical trial notification (CTN) was approved to initiate a Phase 3 clinical study of batoclimab in thyroid eye disease (TED) in Japan.
HL161ANS
Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.
º Immunovant announced positive initial Phase 1 600 mg MAD results for HL161ANS (IMVT-1402) in November 2023. In the study, four once-weekly subcutaneous injections of 600 mg HL161ANS reduced total IgG level by a mean of 74%, demonstrating comparable potency to batoclimab 680 mg, which reduced IgG by 76% after four weekly doses. Overall, HL161ANS consistently demonstrated a significant reduction in IgG levels with potency similar to or greater than that of batoclimab, with no significant decrease in serum albumin or significant increase in LDL-cholesterol levels at day 29 (peak pharmacodynamics impact) from baseline (p-values > 0.05).
OPHTHALMIC DISEASE
PROGRAM
Tanfanercept (HL036)
A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation
º HanAll Biopharma and Daewoong Pharmaceutical successfully concluded discussions with the FDA in the second half of 2023, finalizing the Phase 3 VELOS-4 study design and development plan. The anticipated initiation of the VELOS-4 study is set for the first half of 2024.
º The concluded Phase 3 VELOS-3 study revealed a significant improvement in the unanesthetized Schirmer test, a secondary efficacy endpoint measuring changes in tear volume from baseline in individuals treated with tanfanercept 0.25% compared to the vehicle. This improvement, assessed at week 8, demonstrated a highly statistically significant outcome (p=0.002). Furthermore, a noteworthy proportion of participants in the tanfanercept group (13%) exhibited a Schirmer test improvement of at least 10 mm from baseline at week 8, which was statistically significant (p=0.011) compared to the vehicle group (4%). It is worth mentioning that, according to the FDA's 2020 Draft Guidance on Dry Eye Drug Development, achieving a statistically significant difference in the percentage of patients with a minimum 10 mm increase in the Schirmer test is considered an acceptable primary efficacy endpoint. The FDA has also outlined an alternative approval pathway, requiring the demonstration of a statistically significant difference in an objective predefined sign of dry eye and, additionally, at least one subjective predefined symptom of dry eye. However, this second pathway often involves increased complexity, necessitating additional studies.
NEUROLOGY PROGRAM
HL192 (ATH-399A)
A pipeline candidate originated from NurrOn Pharmaceuticals that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).
º HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals are progressing with the Phase 1 clinical trial of HL192 in healthy participants. The results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024.
ONCOLOGY PROGRAMS
HL187/ HL186
HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.
º HanAll is currently advancing the pre-clinical examination of HL187 (anti-TIGIT) and concurrently evaluating the prospects of HL186 (anti-TIM-3) as part of the ongoing strategic portfolio review.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in billion) |
2023 |
2022 |
% change |
Sales |
135 |
110 |
+22.7% |
Gross Profit |
75 |
62 |
+21.3% |
Selling, marketing and administrative expenses |
49 |
44 |
+11.5% |
Research and development expenses |
24 |
16 |
+45.1% |
Operating income |
2.2 |
1.5 |
+46.9% |
Net Income |
3.5 |
0.3 |
+1295.2% |
Sales generated 135 billion KRW in 2023, a 22.7% increase compared to 2022. Sales remained strong with its major products including Normix, Eligard, and Biotop.
R&D expenses, reported as 24 billion KRW, a 45.1% increase compared to 2022.
Operating income was 2.2 billion KRW, a 46.9% increase compared to the same period in 2022.
Net income was 3.5 billion KRW, compared to 300 million KRW in 2022.
About HanAll Biopharma
HanAll Biopharma (KRX: 009420.KS) is a
global biopharmaceutical company with a presence in Korea, the USA, Japan, and
Indonesia with a mission of making meaningful contributions to patients' lives
by introducing innovative, impactful medicines to address severe unmet medical
needs. HanAll has been operating a portfolio of pharmaceutical products in the
areas of endocrine, circulatory, and urologic diseases for over 50 years.
HanAll has also expanded its focus to
immunology, oncology, neurology, and ophthalmology to discover and develop
innovative medicines for patients with diseases for which there are no effective
treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn
antibody, is being developed in Phase 3 and Phase 2 trials across the world for
the treatment of autoimmune diseases including myasthenia gravis (MG), thyroid
eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP),
and Graves’ disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF
inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and
China for the treatment of dry eye 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 2024 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 update or revise the information in this press release,
including any forward-looking statements, except as may be required by Korean
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