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- ​Financial results for the first quarter ended with revenue of KRW 28.8 billion, up by 20 percent compared to the same period in 2022

- ​HanAll made a strong start to 2023 with positive Phase 3 study results of anti-FcRn asset batoclimab for the treatment of generalized myasthenia gravis in China, setting a monumental milestone for anti-FcRn developers in the global market

- ​HanAll is on track with its ongoing pivotal Phase 3 clinical study of tanfanercept (VELOS-3) in dry eye disease in the first half of 2023

Rockville, MD, Seoul, KR – April 28, 2023​

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

HanAll’s financial data demonstrated a strong momentum in the start of 2023, with revenues of KRW 28.8 billion, representing a 20 percent sales growth mainly driven by pharmaceutical sales from the first quarter of 2022. The company reported a net loss of 1.3 billion won due to continued investment in R&D.  

Following the previous statement from the 2022 full-year financial report, HanAll expects to secure top-line data from the tanfanercept Phase 3 clinical study in dry eye disease in the first half of 2023 and plans to initiate a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan this year.

“The recent positive top-line result from gMG Phase 3 study by Harbour BioMed suggests the potential of batoclimab as the first anti-FcRn treatment to be commercialized in China, reinforcing our confidence to develop batoclimab in an array of autoimmune diseases. With a strong focus on collaboration and innovation, we will continue to push forward with our R&D programs to deliver groundbreaking medicines that will make a difference in the patients’ lives,” said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

First Quarter 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 and targeted indications, along with developmental phase.

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 and inhibit FcRn, which plays a role in recycling IgG, thus leading to a reduction in IgG antibodies.

l  Harbour BioMed, a licensed partner of HanAll in China, announced the first positive Phase 3 top-line results for batoclimab in generalized myasthenia gravis (gMG) subjects in March 2023. Data from the trial met the primary endpoint as well as key secondary endpoints. Batoclimab treatment was also found to be overall safe and well-tolerated, without any new significant safety signals identified. Harbour BioMed plans to submit a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) for batoclimab together with its sub-licensee CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited (CSPC Pharmaceutical), based on the study results. Batoclimab is also being developed for study in China in an array of other autoimmune disorders including thyroid eye disease (TED).

l  HanAll is progressing towards initiation of a Phase 3 clinical study of batoclimab in gMG in Japan this year. Additionally, HanAll is exploring options for developing batoclimab in TED and chronic inflammatory demyelinating polyneuropathy (CIDP) in Japan.

l  Another licensed partner, Immunovant in the U.S. and Europe, is conducting global Phase 3 trials with batoclimab in gMG and TED. Additionally, the initial data readout for a Phase 2 trial in Grave’s disease (GD) is anticipated in the second half of 2023 and an initial Phase 2b results in CIDP is expected in the first half of 2024.

HL161ANS

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG, designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.

l  Immunovant anticipates initial results from a Phase 1 trial for HL161ANS, a new FcRn inhibitor (Immunovant project designation: IMVT-1402), in the second half of 2023. Immunovant also plans to evaluate HL161ANS in multiple autoimmune diseases, based on strategic portfolio considerations.

OPHTHALMIC DISEASE PROGRAMS

Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF alpha, a key mediator of ocular inflammation

l  HanAll Biopharma and Daewoong Pharmaceutical are progressing with the second Phase 3 (VELOS-3) study in the U.S. in subjects with moderate to severe DED to examine the safety and efficacy of tanfanercept. Study enrollment is complete and the top-line results from the VELOS-3 study are expected in the first half of 2023.

l  Harbour BioMed, a licensed partner of HanAll in China, closed its Phase 3 China study in DED, based on the Independent Data Monitoring Committee’s (IDMC) evaluation of the efficacy data from the second interim analysis. The HanAll U.S. study (VELOS-3) differs from the Harbour Chinese study in a number of ways including key inclusion criteria, primary endpoints, as well as subject demographics. The future development plans for tanfanercept in China are under discussion.

ONCOLOGY PROGRAMS

HL187/ HL186

Monoclonal antibodies that respectively target T cell immunoreceptors with Ig and ITIM {Immunoreceptor tyrosine-based inhibitory motif} domains (TIGIT) and T cell immunoglobulin and mucin domain-3 (TIM-3) are being developed in collaboration with Daewoong Pharmaceutical. as potential oncology treatments

l  HanAll is continuing with the pre-clinical development of HL187 asset and plans to evaluate the further development of HL186 based on the strategic portfolio review.  

FINANCIAL HIGHLIGHTS (CONSOLIDATED) 

Key Highlights 

Sales recorded 28.8 billion won in the first quarter of 2023, a 20 percent increase compared to the first quarter of 2022. Pharmaceutical sales remained strong with major products including Normix, Eligard, along with the newly launched products such as Abcito and Glucofree. 

Research and development expenses for the first quarter ended March 31, 2023 were 5.9 billion won, up 88 percent from 3.1 billion won for the three months ended March 31, 2022. The increase was primarily due to continued progress in VELOS-3 study, along with the investment to the ongoing oncology projects.

Net loss for the three months ended March 31, 2023 recorded 1.3 billion won from the 0.1 billion won for the same period in 2022.  

About HanAll Biopharma Co., Ltd. 

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients’ lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 50 years.   

HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology 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-alpha 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 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 2023 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 law and regulations.