HanAll Biopharma and Daewoong Pharmaceutical Enter into Co-Development Agreement with NurrOn Pharmaceuticals to Develop Therapy for Parkinson's Disease

• HanAll Biopharma and Daewoong Pharmaceutical will co-develop NurrOn Pharmaceuticals' novel investigational compounds, including its lead asset ATH-399A, targeting Nurr1 for the treatment of Parkinson's disease (PD), as well as other neurodegenerative disorders
• Phase 1 clinical trial is expected to be initiated in 2023

ROCKVILLE, Md. and SEOUL, South Korea, May 25, 2023 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS) and Daewoong Pharmaceutical Co., Ltd. (KRX: 069620.KS) announced that they have entered into a co-development agreement with NurrOn Pharmaceuticals Inc., a Boston-based preclinical-stage biopharma. NurrOn is focused on the discovering and developing novel therapies for people with neurodegenerative diseases including Parkinson's disease (PD) by targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance. HanAll and Daewoong also participated in a Series A funding of NurrOn in 2021.

NurrOn was founded by Kwang-Soo Kim, Ph.D., Professor and Director of the molecular neurobiology laboratory at Harvard Medical School, and Deog Joong Kim, Ph.D. and was seed-funded by George A. Lopez, M.D., former CEO of ICU Medical, Inc. Using the technology, NurrOn is advancing the development of its lead compound ATH-399A, which potentially slows the progression of the disease in PD patients by activating Nurr1, a class of proteins crucial to the development and maintenance of dopamine in the brain.

Under the agreement, the companies will combine their expertise and resources in developing NurrOn's ATH-399A as well as other compounds targeting Nurr1 for the treatment of neurodegenerative disorders.

"We are excited to move into the next phase of collaboration with NurrOn continuing to build on the partnership which was originally established in 2021. This partnership would allow us to join our resources and expertise in developing new medicines for patients with PD worldwide," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

"NurrOn has completed the preclinical development of ATH-399A and plans to enter a Phase 1 clinical trial this year. We expect great synergy through the joint collaboration between NurrOn, HanAll Biopharma and Daewoong Pharmaceuticals, especially given their great clinical development expertise." said Deog Joong Kim, Ph.D., CEO of NurrOn Pharmaceuticals.

In addition to proceeding towards a Phase 1 trial of its Parkinson's therapy candidate ATH-399A, the partners will continue to explore the potential of ATH-399A in other neurodegenerative diseases.

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 oncology, immunology, 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-alpha inhibitor protein, is being evaluated in Phase 3 clinical trials 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). 

About Daewoong Pharmaceutical. Co., Ltd.

Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on their course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide.

In 2022, Daewoong expanded its global market presence by entering into a license agreement worth USD 923 million, which granted permission for the use of Fexuclue, a medicine licensed for the treatment of gastroesophageal reflux disease, in the Philippines and Ecuador within the first year of its launch. Additionally, Daewoong successfully launched Envlo, the first-ever sodium glucose cotransporter 2 (SGLT2) inhibitor for the treatment of diabetes to be developed in Korea, and signed an export contract worth USD 84.36 million with Brazil and Mexico. For further information on Daewoong Pharmaceutical, please visit our official website.

About NurrOn Pharmaceuticals Inc.

NurrOn Pharmaceuticals Inc. is a preclinical-stage biopharmaceutical company dedicated to developing novel, targeted therapeutics for the treatment of Parkinson's disease (PD) and other Nurr1-related incurable human disorders.

Through targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance, we aim to develop a paradigm changing PD treatment to improve patients' quality of life. While currently there are only symptomatic treatment options for patients with PD, there have not been any successful therapies to slow or prevent the progression of the disease. We believe that disease-modifying therapies will be achieved through targeting Nurr1, which has generated supportive data as a new druggable PD target. NurrOn was recently awarded as substantial grant from Michael J. Fox Foundation in support of the Phase 1 clinical trial of ATH-399A, scheduled to initiate in 2023.

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.