Ildong Pharmaceutical Co., Ltd.

OSAKA, Japan, Dec 19, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that its partner Ildong Pharmaceutical Co., Ltd. (Head Office: Seoul, South Korea; Vice Chairman and Chief Executive Officer: Yun Paul Woongsup, hereafter "Ildong") who has been sub-licensed South Korean rights to Ensitrelvir Fumaric Acid (hereafter "ensitrelvir"), have announced their new plan to resubmit a New Drug Application (NDA) for ensitrelvir in South Korea with additional data. The Ministry of Food and Drug Safety (MFDS) in South Korea has been reviewing the NDA submitted by Ildong1. As the review progressed, Ensitrelvir demonstrated a favorable effect in preventing symptomatic COVID-19 in the SCORPIO-PEP trial (post-exposure prophylaxis trial)2. Based on this result, Shionogi and Ildong have agreed that to revise and augment the NDA for Ensitrelvir, including all currently available data in the application package, similar to the approach taken for applications in the United States and Europe, is the best way to deliver ensitrelvir to patients in South Korea. Consequently, the current application has been withdrawn voluntarily by Ildong, and a new application with additional data will be submitted. Shionogi is committed to the principle “Protecting people worldwide from the threat of infectious diseases” as our key focus, and is working on the realization of total care for infectious diseases. Shionogi is continuing to progress its extensive global development program for ensitrelvir, and will continue research and development for COVID-19 so as to be prepared for the swift provision of therapeutic drugs and vaccines as necessary depending on the situation, such as the emergence of new variants or increases in the future prevalence of, or threat from, the disease. For Further Information, Contact: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html References 1. Press release on Dec 27, 2023 Filing for a Manufacturing License for Ensitrelvir Fumaric Acid, a Therapeutic Drug for COVID-19 to Build a Domestic Drug Product Production and Supply System in South Korea 2. Press release on Oct 31, 2024 Shionogi Announces Global Phase 3 Trial Demonstrates Post-Exposure Prophylactic Use of Ensitrelvir Prevents Symptomatic COVID-19

SEOUL, South Korea, Aug. 27, 2024 /PRNewswire/ -- Yunovia, a drug R&D subsidiary of Ildong Pharmaceutical Group, announced on the 26th that the Ministry of Food and Drug Safety (MFDS) of Korea has cleared the IND application of Phase 1 Multiple Ascending Dose (MAD) study for ID110521156, an orally available small molecule GLP-1 agonist being developed for obesity and diabetes following the successful completion of the Phase 1 Single Ascending Dose (SAD) study. Phase 1 MAD study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) characteristics of ID110521156 following repeated administration and stepwise increase in dose. Previously, Yunovia not only confirmed the drug's effectiveness related to insulin secretion and blood glucose control, but also, its superior tolerability compared to other drugs in the same class through preclinical efficacy and toxicity evaluations in the recently completed Phase 1 SAD study. ID110521156 is a GLP-1 (glucagon-like peptide-1) receptor agonist that plays the same role as the GLP-1 hormone which is involved in the synthesis and secretion of insulin in the body, reduction of blood glucose level, regulation of gastrointestinal tract movements, and appetite suppression. Since ID110521156 is a small molecule compound, the Company's strategy is to develop it as an orally administrable drug for diabetes and obesity with differentiated attributes such as superior manufacturability and ease of use compared to peptide injections, the current standard of care. A Yunovia representative emphasized, "ID110521156 is the only small molecule based new drug in the clinical stage among all GLP-1 receptor agonists in Korea, and even by the global market standards, it falls within the group of GLP-1 receptor agonists whose development status is relatively advanced." The Company representative further stated, "We had been communicating with potential partner companies from the early development stage where their feedback from the perspective of the needs of the 'GLP-1 market', had been reflected in the designing of the SAD and MAD studies" Based on our continuing dialogue with them, we will proceed with further development of ID110521156 and, pursue global out-licensing. About ID110521156 ID110521156 is an orally available small molecule agonist of the GLP-1 receptor. Yunovia completed its Phase I SAD, including food effect study, in July 2024. ID110521156 was well tolerated and demonstrated potential as a once-daily drug with a sustained PK profile. The company plans to collect PD data, including continuous glucose monitoring and body weight changes, as exploratory endpoints from a 4-week MAD study. About Yunovia Yunovia was established in 2023 as a split-off from Ildong pharmaceutical to release the full potential value of global, innovative drug pipeline and to maximize the R&D productivity for accelerated drug development. Yunovia's R&D pipeline includes more than 20 innovative programs at various development stages for various therapeutic areas. With its small molecule R&D expertise and pipeline, including 3+ clinical programs, Yunovia will strive to grow as a leading innovator for life changing therapeutics. For more information, please visit . CONTACT: Hyang Choi, Business Development Team 2, Deputy General Manager, +82-2-526-3288, [email protected] SOURCE Yunovia

DONGTAN, KOREA, June 10, 2024 - iLeadBMS, a new drug R&D company under Ildong Pharmaceutical Group, announced on the 10th that it presented in vivo study results on its liver fibrosis treatment candidate 'IL1512' at the European Association for the Study of the Liver (EASL) 2024, held in Milan, Italy, from June 5th to the 8th. IL1512 is an oral CXCR7 agonist and is classified as a first-in-class drug, a type of drug that has never been developed for the same therapeutic indication previously. Last month, iLeadBMS presented the efficacy results of this drug for idiopathic pulmonary fibrosis (IPF) at the American Thoracic Society (ATS 2024), and this time around it announced the anti-fibrotic effects of the drug in the liver. CXCR7 is a G protein-coupled receptor that binds to chemokine ligands CXCL11 and CXCL12, targeting various pathways related to fibrosis such as fibroblast activation, inflammation, tissue repair, and angiogenesis. This makes it an ideal therapeutic target for treating fibrotic diseases. Given that CXCR7 agonists exerts their anti-fibrotic properties through a novel mechanism, iLeadBMS plans to develop anti-fibrotic drugs to treat fibrosis in various organs including but not limited to the lungs, liver, heart, kidneys, and skin, and is also considering utilizing the expedited review and Orphan Drug Designation (ODD) pathways offered by the FDA. Based on the presentation at the conference, iLeadBMS has confirmed the anti-fibrotic effects of IL1512 in the well-established CCl4 (carbon tetrachloride) liver fibrosis model with oral administration of the test article. Significant improvements in various anti-fibrotic indicators (col 1a1, hydroxyproline content, TGF-beta) were observed compared to the placebo. The presentation emphasized that IL1512, with its novel mechanism targeting CXCR7, demonstrated direct anti-inflammatory effects on the liver and improvement in fibrosis. Additionally, it highlighted that IL1512 showed either superior or at minimum, comparable efficacy and safety profiles compared to Elafibranor, the comparator drug. Based on these research results, iLeadBMS has identified preclinical candidate molecules with even greater improvements over IL1512 and, plans to start GLP (Good Laboratory Practice) toxicology studies in the second half of this year. About iLeadBMS Established in 2020, iLeadBMS specializes in the discovery and development of novel drugs, with an R&D pipeline targeting fibrotic diseases, protease inhibitors, solid tumors, and neurodegenerative diseases. For more information on iLeadBMS, please visit: