On 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 (Press release, HanAll Biopharma, MAR 21, 2024, View Source [SID1234641358]).
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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.
"2023 marked a significant milestone as we celebrated our 50th anniversary. We have delivered record-high sales performance, with continued advancements in our R&D programs by adding the Parkinson’s disease program, completing the VELOS-3 study in dry eye, and securing meaningful outcomes from the Phase 1 study of HL161ANS, our second anti-FcRn asset," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.
"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.
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.
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.
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.
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
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.
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).
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.
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.