A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0% Compared to Vehicle in Participants With Dry Eye Disease (VELOS-4)

The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.

Start Date01 May 2024

Sponsor / Collaborator

HANALL BIOPHARMA Co., Ltd.

NCT05109702 / CompletedPhase 3

A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% Compared to Placebo in Subjects With Dry Eye

The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.

Start Date18 Nov 2021

Sponsor / Collaborator

HANALL BIOPHARMA Co., Ltd.

[+1]

CTR20202142 / Active, not recruitingPhase 3

一项评价HBM9036（HL036）滴眼液（0.25%）与安慰剂相比治疗中国中、重度干眼患者的有效性和安全性的3期、多中心、随机、双盲、安慰剂对照研究

[Translation] A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBM9036 (HL036) eye drops (0.25%) compared with placebo in the treatment of moderate to severe dry eye in Chinese patients

评价HBM9036（HL036）滴眼液（0.25%）与安慰剂相比治疗中国中、重度干眼患者的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of HBM9036 (HL036) eye drops (0.25%) compared with placebo in the treatment of moderate to severe dry eye in Chinese patients.

Start Date25 Feb 2021

Sponsor / Collaborator

BINEX Co., Ltd.

[+3]

100 Clinical Results associated with Tanfanercept

100 Translational Medicine associated with Tanfanercept

100 Patents (Medical) associated with Tanfanercept

2,386

Literatures (Medical) associated with Tanfanercept

01 Dec 2024·International Journal of Surgery Case Reports

Left lateral-aortic paraganglioma in an adolescent: A rare case report

Article

Author: Bouichrat, N ; Derbel, S ; Rouf (Pr), S. ; Rouf Pr, S ; El Yamani, N. ; Derbel, S. ; El Yamani, N ; Assarrar, I. ; Latrech, H. ; Latrech, H ; Bouichrat, N. ; Assarrar, I

INTRODUCTION:

Paraganglioma is a rare neuroendocrine tumor arising outside the adrenal gland from the primitive neural crest cells. The pediatric form is an exceptional entity.

CASE REPORT:

Here we report a case of a 15-year-old boy presenting with hypertensive crisis. Computed tomography scan revealed a left lateral-aortic paraganglioma, with significantly elevated plasmatic catecholamine levels. Preoperative management was conducted in our patient with selective alpha-1 blockers, then complete resection of the tumor was achieved without complications. The histological and immunohistochemical examination confirmed the diagnosis of a paraganglioma.

DISCUSSION:

Paranganglioma management should be started as soon as possible to prevent high blood pressure complications. It is based on preoperative medication with alpha-blocker to prevent adrenegeric discharge, followed by a complete and safe surgical removal of the tumor.

CONCLUSION:

Functional paraganglioma remains a rare entity among pediatric population. Preoperative management is mandatory to avoid postoperative morbidity.

01 Nov 2024·JOURNAL OF INTERNAL MEDICINE

Tadalafil use is associated with a lower incidence of Type 2 diabetes in men with benign prostatic hyperplasia: A population‐based cohort study

Article

Author: Yoshida, Satomi ; Takayama, Atsushi ; Kawakami, Koji

Abstract:

Background:

Tadalafil, commonly prescribed for benign prostatic hyperplasia (BPH), may benefit patients with Type 2 diabetes mellitus (T2DM) for glycemic markers and complications. However, the association between the long‐term use of tadalafil and the incidence of T2DM has not been investigated.

Methods:

We emulated a target trial of tadalafil use (5 mg/day) and the risk of T2DM using a population‐based claims database in Japan. Patients who initiated tadalafil or alpha‐blockers for BPH and had no history of diabetes diagnosis, no dispensing of glucose‐lowering drugs, and no history of hemoglobin A1c levels of ≥6.5% (47–48 mmol/mol) were included. The primary outcome was the incidence of T2DM. Pooled logistic regression was used to estimate adjusted risk ratios (RRs) and 5‐year cumulative incidence differences (CIDs).

Results:

A total of 5180 participants initiated tadalafil treatment and were compared with 20,049 patients who initiated alpha‐blockers. The median follow‐up time for each arm was 27.2 months (interquartile range [IQR], 12.0–47.9) in tadalafil users and 31.3 months (IQR, 13.7–57.2) in alpha‐blocker users. The incidence rates of T2DM in tadalafil and alpha‐blocker users were 5.4 (95% confidence interval [CI], 4.0–7.2) and 8.8 (95% CI, 7.8–9.8) per 1000‐person years, respectively. Initiation of tadalafil was associated with a reduced risk of T2DM (RR, 0.47; 95% CI, 0.39–0.62; 5‐year CID, −0.031; 95% CI, −0.040 to −0.019).

Conclusion:

The incidence of T2DM was lower in men with BPH treated with tadalafil than in those treated with alpha‐blockers. Thus, tadalafil may be more beneficial than alpha‐blockers in preventing T2DM.

15 Oct 2024·Romanian journal of ophthalmology

Floppy iris. How is floppy iris syndrome managed? What do urologists and ophthalmologists say?

Article

Author: Stănilă, Dan Mircea ; Bumbuluț, Bogdan

Introduction:

This study focuses on the effect of chronic treatment on the eye, regarding the so-called Intraoperative Floppy Iris Syndrome (IFIS) or Floppy Iris Syndrome, which can occur during cataract surgery.

Aim:

The study aimed to establish the influence of tamsulosin, used in benign prostatic hyperplasia (BPH) treatment on the iris, during cataract surgery, considering the increased incidence of both conditions in older age.

Methods:

This study included one hundred male patients, operated on for cataracts at the Ofta Total Clinic and Dr. Stănilă Medical Centre, in Sibiu, out of 601 patients operated on for cataracts between February and October 2022. Of the 100 patients, 24 used medication for BPH. 5 patients used prostamol, a phytotherapeutic preparation, which is an extract from Serenoarepens, and the remaining 19 used tamsulosin, which is an alpha-blocker, most commonly used in the treatment of BPH, considered the first-line treatment option.

Results:

In 15 patients, we intraoperatively managed, a medium mydriasis through pharmacological dilation, including intracameral administration of phenocaine and mechanical dilation or stripping. In 4 patients it was necessary to apply iris dilators. Due to the small pupil in 2 patients, we caught the iris in the phacoemulsification probe, and a small, incomplete iris coloboma was formed. Sometimes, there was a turnover of Descemet in 4 patients. The pupil remained semi-dilated and slightly areflective in the patients to whom we applied iris hooks. The patients' visual acuity was satisfactory, between 0.9 and 0.6.

Discussions:

The topic gives rise to many discussions. It seems that stopping the administration of tamsulosin for a short time does not help the occurrence of IFIS, because the iris lesions seem irreversible. Patients at risk of developing cataracts should be evaluated and possibly referred to an ophthalmologist to determine surgery before starting treatment for BPH and to competently assess the administration of this medication.

Conclusions:

Collaboration between urologists and ophthalmologists is required for patients prone to the appearance of cataracts since both conditions are frequently encountered in elderly patients.

News (Medical) associated with Tanfanercept

01 Nov 2024

·www.prnewswire.com

HanAll Biopharma Reports Q3 2024 Financial Results and Provides Business Update

HanAll records revenue of 36.8 billion KRW in the third quarter, with an operating profit of 430 million KRW. Results for the Phase 1 study in healthy subjects for HL192 (ATH-399A), a novel compound targeting Parkinson's Disease, are expected in November 2024. ROCKVILLE, Md. and SEOUL, South Korea, Nov. 1, 2024 /PRNewswire/ -- 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 third quarter of 2024 and provided business updates. HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical sales reached 34 billion KRW from robust sales of key products. In the third quarter, HanAll's anti-FcRn assets demonstrated potential as best-in-class treatments for a range of autoimmune diseases, particularly Graves' Disease. Ongoing studies include a Phase 2b trial in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) as well Phase 3 studies in generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED), with topline results expected in the first quarter of 2025 and first half of 2025, respectively. Additionally, HanAll, in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed the Phase 1 study of HL192 in healthy subjects. Results for the HL192 Phase 1 study are anticipated in November of this year. "This past quarter, HanAll's focus and agile execution have positioned us for significant growth while allowing us to continue our R&D efforts through strategic, value enhancing cost optimization. Looking ahead, we are committed to expanding our competitive advantage by specializing in key products and strengthening our R&D capabilities as we strive to realize our highest potential as a global company," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. Third Quarter 2024 BUSINESS UPDATE Pipeline Development Highlights A comprehensive update of HanAll's public 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, a member of the Roivant group of companies, as well as HanAll's licensed partner in the United States and Europe, is making progress across four autoimmune indications. Phase 3 studies in gMG and TED are advancing, with topline results expected in the first quarter of 2025 and first half of 2025, respectively. Immunovant reported positive results from the Phase 2a study of batoclimab in Graves' Disease. The study demonstrated that a higher dose of batoclimab achieved a 76% response rate in patients who were not adequately controlled on antithyroid drugs (ATDs) by 12 weeks of treatment. The ATD-free response rate for these patients at the same time point was 56%. Immunovant is progressing with subject enrollment in the ongoing Phase 2b study for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The data obtained from this study will also be utilized to refine the study design for a potential registrational program for IMVT-1402 in CIDP. Initial results from the first period of the Phase 2b study are anticipated in the first quarter of 2025. Harbour BioMed, another licensed partner which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in the Greater China region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), resubmitted the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in June 2024, which was accepted by the NMPA in July 2024. The BLA incorporated additional long-term safety data from the Phase 3 study in gMG which concluded in June 2023. HL161ANS (IMVT-1402) 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 plans to initiate a pivotal study in Graves' Disease (GD) leveraging findings from the batoclimab Phase 2a study in GD data. The results from the previous study indicate a significant correlation between the reduction of IgG levels and clinical outcomes, underscoring the potential of HL161ANS/IMVT-1402 as a best-in-class treatment option for patients with GD. Immunovant intends to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the conclusion of the first quarter of 2025. Additionally, the company plans to commence studies for IMVT-1402 across a total of up to 10 indications (in the aggregate) by the end of the first quarter of 2026. The company is also exploring initiating a registrational development in gMG with IMVT-1402. Immunovant will work to optimize the HL161ANS/IMVT-1402 CIDP trial design, drawing insights from the ongoing CIDP Phase 2b trial for batoclimab. 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 are conducting the Phase 3 VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye disease. The topline results for the study are expected in 2026. The Phase 3 VELOS-4 trial builds upon key insights gained from the completed Phase 3 VELOS-3 study. In VELOS-3, tanfanercept demonstrated a statistically significant improvement in the secondary efficacy endpoint of tear volume, as measured by unanesthetized Schirmer testing, in patients treated with tanfanercept compared to those in the vehicle group at week 8 (p=0.002). In addition, a post hoc analysis revealed that a notable proportion of participants in the tanfanercept group (14%) showed significant improvement (p=0.011) in the Schirmer test, with an increase of at least 10mm from baseline at week 8, compared to only 4% in the vehicle group. The 2020 FDA Draft Guidance on Dry Eye Drug Development considers the proportion of participants achieving a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval. NEUROLOGY PROGRAM HL192 (ATH-399A) A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School's Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson's disease (PD). The Phase 1 study of HL192, being developed in collaboration with NurrOn Pharmaceuticals, HanAll Biopharma, and Daewoong Pharmaceutical, has completed dosing with the results expected in November 2024. ONCOLOGY PROGRAMS 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 decided to discontinue its monoclonal antibody programs targeting TIM-3 and TIGIT, following the recent data outcomes and decisions from other global companies to cease their programs. HanAll is exploring the potential for developing a new asset for a different oncology target. FINANCIAL HIGHLIGHTS (CONSOLIDATED) Key Highlights 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. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic 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. One of its lead pipeline assets, 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 generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is being evaluated in multiple indications including GD. Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers, with results to be announced in November 2024. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). 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 law and regulations. SOURCE HanAll Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultPhase 3Financial Statement

26 Jul 2024

·www.prnewswire.com

HanAll Biopharma Reports Q2 2024 Financial Results and Provides Business Update

HanAll reports strong financial performance with second quarter total revenue of 31.6 billion KRW, driven by the strong sales from the key products. HanAll expands collaboration with Turn Biotechnologies through an exclusive licensing agreement for Epigenetic Reprogramming of Aging (ERATM) technology, targeting ophthalmic and otic diseases. Progress in clinical development programs continued including the completion of Phase 1 study for HL192 (ATH-399A) in Parkinson's Disease, with results expected in the second half of 2024 and initiation of VELOS-4 Phase 3 study on tanfanercept for Dry Eye Disease. ROCKVILLE, Md. and SEOUL, South Korea, July 26, 2024 /PRNewswire/ -- 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 second quarter of 2024 and provided business updates. HanAll ended the second quarter with total revenue of 31.6 billion KRW and an operating loss of 3.1 billion KRW. Sales revenue reached 28.1 billion KRW, reflecting a 5.4% increase from the same period in 2023, bolstered by robust sales of key products. The overall profitability for the second quarter turned to a loss due to the absence of milestone revenues from the licensed partner. Within the past quarter, HanAll strengthened its relationship with Turn Biotechnologies, a company founded on licensed technologies from Stanford, culminating in an exclusive licensing agreement to explore the potential of transient epigenetic reprogramming with the use of Yamanaka factors for ophthalmic and otic diseases. HanAll also completed a Phase 1 first in human study of HL192 (ATH-399A) targeting Parkinson's Disease, with results anticipated in the second half of 2024. HanAll's research and development efforts have achieved significant progress with the initiation of the Phase 3 VELOS-4 study investigating tanfanercept for dry eye disease (DED), with the topline results expected in 2026. Progress in anti-FcRn assets continued, with the potential advancement of HL161ANS (IMVT-1402)'s development program. Top-line results are anticipated from the ongoing batoclimab Phase 2b study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Phase 3 study in generalized Myasthenia Gravis (gMG) in the first quarter of 2025. Additionally, the resubmission of the Biologics License Application (BLA) in China for gMG marked a significant milestone, bringing batoclimab one step closer to commercialization. A total of 10 additional studies are being planned for HL161ANS (IMVT-1402). The initiation of studies for the first 4 to 5 potentially registrational studies is slated to begin by the first quarter of 2025. The remaining indications are slated to be initiated by the first quarter of 2026. "HanAll made a meaningful progress in our R&D in the second quarter, including the completion of the HL192 Phase 1 study in PD, the initiation of the VELOS-4 Phase 3 study for dry eye, and the establishment of a licensing agreement with Turn.bio to develop medicines for age-related diseases. We will sustain our investment in R&D through enhancing efficiency of our operations," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. Second Quarter 2024 BUSINESS UPDATE Pipeline Development Highlights A comprehensive update of HanAll's public 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, a member of the Roivant group of companies as well as HanAll's licensed partner in the United States and Europe, is making progress across four autoimmune indications. Results from the batoclimab study in Graves' disease are expected in fall of 2024 from Immunovant. Phase 3 studies in gMG and TED are advancing. Topline data from the Phase 3 study in generalized Myasthenia Gravis (gMG) is also anticipated in the first quarter of 2025. Progress continues in the Phase 3 study for Thyroid Eye Disease (TED), with the top-line results also projected in the first half of 2025. Regarding the ongoing Phase 2b Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) study, Immunovant has decided to extend the duration of the study in order to optimize the study design for IMVT-1402 in CIDP. Following this decision, initial results from period 1 of the Phase 2b study in CIDP are expected in the first quarter of 2025. Harbour BioMed, another licensed partner which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in the Greater China region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), has resubmitted the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in June 2024. The BLA incorporated supplementary long-term safety data from the Phase 3 study in gMG, concluded in June 2023. HL161ANS (IMVT-1402) 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 plans to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the end of first quarter of 2025, following a recent Type B meeting with the FDA (Food and Drug Administration). The company plans to initiate studies on IMVT-1402 in a total of 10 indications before the end of the first quarter of 2026. Immunovant is exploring initiating a registrational development in gMG with IMVT-1402. Immunovant will work to optimize the HL161ANS/IMVT-1402 CIDP trial design, drawing insights from the ongoing CIDP Phase 2b trial for batoclimab. This process involves extending the duration of Phase 2b study in batoclimab in CIDP and incorporating learnings from the previous studies. Immunovant also plans to provide an overview of the development program for HL161ANS/IMVT-1402 in Grave's disease (GD) in the second half of 2024. 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 initiated the Phase 3 VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye. The topline results for the VELOS-4 study is expected in 2026. The Phase 3 VELOS-4 trial builds upon key insights gained from the completed Phase 3 VELOS-3 study. In VELOS-3, tanfanercept demonstrated a statistically significant improvement in the secondary efficacy endpoint of tear volume, as measured by unanesthetized Schirmer testing, in patients treated with tanfanercept compared to those in the vehicle group at week 8 (p=0.002). In addition, a post hoc analysis revealed that a notable proportion of participants in the tanfanercept group (14%) showed significant improvement (p=0.011) in the Schirmer test, with an increase of at least 10mm from baseline at week 8, compared to only 4% in the vehicle group. The 2020 FDA Draft Guidance on Dry Eye Drug Development considers the proportion of participants achieving a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval. NEUROLOGY PROGRAM HL192 (ATH-399A) A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School's Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson's disease (PD). The Phase 1 study of HL192, being jointly developed by HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals, has completed dosing with the results expected in the second half of 2024. ONCOLOGY PROGRAMS 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 continuing with the pre-clinical development of the HL187 (anti-TIGIT) asset and plans to evaluate the further development of HL186 (anti-TIM-3) based on the strategic portfolio review. 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. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic 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. One of its lead pipeline assets, 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 generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). HL161ANS (IMVT-1402), an anti-FcRn antibody targeting multiple indications, is being evaluated in a Phase clinical study (healthy volunteers). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). 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 law and regulations. SOURCE HanAll Biopharma

Phase 1Phase 3Phase 2Clinical ResultLicense out/in

28 May 2024

·www.prnewswire.com

HanAll Biopharma Signs Licensing Agreement with Turn Biotechnologies to Develop Novel Treatments for Eye and Ear Diseases

Exclusive agreement allows HanAll to utilize Epigenetic Reprogramming of Aging (ERATM) technology for ophthalmic and otic diseases. Collaboration aims to leverage HanAll's extensive expertise in ophthalmic and otic diseases and Turn Bio's cellular reprogramming technology to create innovative therapies. Deal value can exceed $300 million USD for the initial product. ROCKVILLE, Md. and SEOUL, South Korea, May 28, 2024 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, has signed an exclusive licensing agreement with Turn Biotechnologies, Inc., a pre-clinical stage biopharmaceutical company focused on cellular repair through epigenetic reprogramming. This agreement expands the relationship between the companies, which began in 2022 when HanAll made an initial investment in Turn Bio. The terms grant HanAll the right to utilize Turn Bio's Epigenetic Reprogramming of Aging (ERATM) technology to research, develop, manufacture, and commercialize medicines for ophthalmic and otic disease. HanAll anticipates leveraging synergies between ophthalmic and otic fields where it has therapeutic expertise and experience, and drawing on Turn Bio's knowledge of cellular reprogramming, mRNAs, and lipid nanoparticles. Aging mitigation and cell reprogramming technologies have been gaining attention for their potential to address the high unmet needs in age-related disorders, particularly in the eye and ear. HanAll has been actively exploring cell reprogramming through open collaborations and a global network. The ERATM technology developed by Turn Bio reverses certain aspects of cellular aging by utilizing a cocktail of mRNA transcription factors specifically designed for transient epigenetic reprogramming. Past attempts at similar technologies have struggled due to the risk of cells differentiating into unforeseen cell types. Turn Bio's technology aims to overcome these challenges by restoring youthful cell function through precise dosing and timing of ERATM while maintaining the original cellular identity, offering promising potential for addressing age-related disorders. Currently, Turn Bio is undertaking pre-clinical research for dermatology and immunology applications. "We're excited to advance into a new phase of development with Turn Bio to explore the potential of its innovative platform in addressing important age-related conditions. This partnership will enhance HanAll's R&D capabilities in mRNA and LNP product development while also providing an opportunity to explore the potential for pipeline expansion," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. "This agreement is a testament to the vast opportunities ahead globally as the world's population grows older," said Turn Bio CEO Anja Krammer. "HanAll's commitment is recognition that our innovative ERA™ technology has the potential to revolutionize treatments for myriad conditions associated with aging." The deal, valued over $300 million USD for the first product, is structured around negotiated milestones. 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. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic 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. One of 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 generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL161ANS, an anti-FcRn antibody targeting multiple indications, and HL192 (ATH-399A), a Nurr1 activator currently targeting Parkinson's Disease, are also being evaluated in Phase 1 clinical studies (healthy volunteers). For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). About Turn Biotechnologies Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level and developing transformative drug delivery systems. The company's proprietary mRNA-based ERA™ reprogramming technology aims to restore optimal gene expression by combatting the effects of aging in the epigenome. This potentially restores cells' ability to prevent or treat disease and heal or regenerate tissue and helps to fight incurable chronic diseases. Turn Bio's eTurna™ delivery platform uses unique formulations to precisely deliver cargo to specific organs, tissues, and cell types. The company is completing pre-clinical research on tailored therapies targeting indications in dermatology and immunology, and developing therapies for ophthalmology, osteo-arthritis, and the muscular system. For more information, see . or contact Jim Martinez, rightstorygroup / [email protected] or +1 (312) 543-9026. 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 law and regulations. SOURCE HanAll Biopharma

Phase 1License out/inPhase 3Phase 2

100 Deals associated with Tanfanercept

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Indication	Highest Phase	Country/Location	Organization	Date
Xerophthalmia	Phase 3	CN	BINEX Co., Ltd.	25 Feb 2021
Xerophthalmia	Phase 3	CN	Harbour Biomed Therapeutics Ltd.	25 Feb 2021
Xerophthalmia	Phase 3	CN	Holopack Verpackungstechnik GmbH	25 Feb 2021
Dry Eye Syndromes	Phase 3	US	HANALL BIOPHARMA Co., Ltd.	10 Mar 2019
Dry Eye Syndromes	Phase 3	US	Daewoong Pharmaceutical Co., Ltd.	10 Mar 2019
Wet Macular Degeneration	Preclinical	KR	HANALL BIOPHARMA Co., Ltd.	27 Jul 2018
Uveitis	Preclinical	KR	HANALL BIOPHARMA Co., Ltd.	17 Jul 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05109702 (VELOS-3, CTgov)	Phase 3	Dry Eye Syndromes	260	0.25% Tanfanercept Ophthalmic Solution (0.25% Tanfanercept Ophthalmic Solution)	bxxcjjoaau(etyxogagdd) = uddlizjiod dxwkwwjxub (ykiewrmsbd, uufynzfmqr - neluxjftdh) View more	-	23 Oct 2023
				Placebo (Placebo)	bxxcjjoaau(etyxogagdd) = pxcfjmdikl dxwkwwjxub (ykiewrmsbd, tyxtyihjdz - wkgpxdhwvy) View more
NCT03846453 (VELOS-2, CTgov)	Phase 3	Dry Eye Syndromes	637	HL036 Ophthalmic Solution (0.25% HL036 Ophthalmic Solution)	yuljrmjtop(dhqonpyldn) = ixjdtjwtiq qaqlhtjyfl (vtpafozrsa, mbjxkmtrzn - nvwtauuapc) View more	-	14 Apr 2022
				Placebo (Placebo)	yuljrmjtop(dhqonpyldn) = ndufjtizoe qaqlhtjyfl (vtpafozrsa, imyaqzeyol - vsopxjcypj) View more
NCT04092907 (Pubmed)	Phase 2	Dry Eye Syndromes	100	Tanfanercept 0.25%	rejxwbuvde(ofefxxanff) = mrtmvldxew utpfheqxyd (smgnfemvmr, 0.62)	Positive	22 Feb 2022
				Placebo	rejxwbuvde(ofefxxanff) = qecewuimvp utpfheqxyd (smgnfemvmr, 0.62)
NCT03334539 (VELOS-1, CTgov)	Phase 2	Dry Eye Syndromes	150	HL036 ophthalmic solution (0.10% HL036 Ophthalmic Solution)	tljxapixig(qeicruiqzs) = dxiuybjwsl xmzjlvjlfj (vhrkuflcrm, icjhtksxbj - zzrmwzvxml) View more	-	26 Jan 2022
				HL036 ophthalmic solution (0.25% HL036 Ophthalmic Solution)	tljxapixig(qeicruiqzs) = ccltgtsuje xmzjlvjlfj (vhrkuflcrm, yqwjyixirl - bfedcejxim) View more
NCT04092907 (CTgov)	Phase 2	Dry Eye Syndromes	100	HBM9036 0.25% Ophthalmic Solution (HBM9036 0.25% Ophthalmic Solution)	mlaqwjyacs(fretoacqtg) = wknheyfejk jqgdnyppat (mngowzakhl, nmgngptjux - hgssjxvvxx) View more	-	11 Aug 2021
				placebo (Placebo Ophthalmic Solution)	mlaqwjyacs(fretoacqtg) = vclnngmrcj jqgdnyppat (mngowzakhl, jjrwssuuvw - ovfwkiilzh) View more
NCT03846453 (VELOS-2, Corporate Publications) Manual	Phase 3	Dry Eye Syndromes	637	HL036	pqgzhldmsp(jiszfhbdwi): P-Value = 0.0624 View more	Positive	28 Jan 2020
				Placebo
EULAR2018	Not Applicable	-	415	anti-tnf-alpha	lbiydvpsmj(fysyicbenq) = nhotegrhxm funohcpgtw (psvbvzkvdt, 24.87 - 77.13)	-	13 Jun 2018
				anti-tnf-alpha	lbiydvpsmj(fysyicbenq) = uebywacyol funohcpgtw (psvbvzkvdt, 28.39 - 71.61)
ACR2014	Not Applicable	Rheumatoid Arthritis	-	MTX monotherapy	zlpaucicrf(qgqsabfudn) = nmffctbtxe dcqxozgglf (zhrozbqqfb )	Positive	14 Nov 2014
				TNFi treatment in combination with MTX or leflunomide	qjbhiamupg(oqnjzqgabw) = myejfhbiuo igelppihjv (rslrqgydvh ) View more
EULAR2008	Not Applicable	Ankylosing Spondylitis metalloproteinase 3 (MMP-3) \| bone alkaline phospahtase (BAP) \| vasoendothelial growth factor (VEGF) ... View more	-	Adalimumab-treated AS patients	keatkvjnlt(tomfdnctgu) = The mean BASDAI decreased by 2.8 points after 36-52 weeks unpxvfmiea (zpjyfiwnjv ) View more	-	11 Jun 2008
EULAR2003	Not Applicable	anti-TNF-alpha	300	Anti-TNF-alpha therapies	yxbvbwjrzb(doqlluatsq) = qnjjmldbnx afnssciozi (eratuzlofw ) View more	-	18 Jun 2003
				MTX	yxbvbwjrzb(doqlluatsq) = zmwkmsehob afnssciozi (eratuzlofw ) View more

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