GNT Pharma Co., Ltd.

** IND submitted to the FDA showing significantly improved patient condition when administered within 70 minutes of arrival at the Emergency Room ** *Multinational Phase 3 Clinical Trial protocols confirmed and initiated with leading global stroke research centers * SEOUL, South Korea, Dec. 11, 2024 /PRNewswire/ -- GNT Pharma Co. Ltd, a late-stage pharmaceutical company founded in 1998 with offices in Seoul Korea, Italy and USA, announced today the results of its latest Phase II ('SONIC') and Phase III ('Rodin') clinical trials study showing that stroke patients who received early administration of Nelonemdaz in combination with endovascular thrombectomy, demonstrated significant improvements in outcomes. These results were presented by Professor Jin Soo Lee, Chair of the Department of Neurology at Ajou University Medical Center at the recent International Conference Stroke Update 2024 (ICSU 2024). Dr BJ Gwag, Chairman and CEO of GNT Pharma commented "we are extremely encouraged with the SONIC and RODIN clinical trials results and excited to announce we have initiated multinational Phase 3 Clinical Trials (RENEW) with world class partners, including more than 20 top university hospitals in Korea as well as UCLA and UPMC Stroke Centers in the USA." Nelonemdaz is the world's first "multi-target" neuroprotection drug designed to reduce brain damage after a stroke or cardiac arrest. It offers superior efficacy compared to single-target neuroprotectants offering dual target action: (1) Inhibition of NMDA receptor subtype NR2B to safely reduce excitotoxicity; and (2) Removal of free radicals to reduce oxidative stress – two major causes of brain cell death following a stroke. Unlike non-selective NMDA receptor inhibitors, Nelonemdaz does not cause adverse effects and its safety has been verified in two Phase 1 trials, three Phase 2 trials, and two Phase 3 trials. There are over 5 million stroke-related deaths globally each year, with a further 5 million survivors annually left with permanent disabilities. This puts a huge strain on healthcare systems worldwide - the World Stoke Organization estimates total stroke-related costs to tip US$1 trillion by 2030. Moreover, stroke frequency is not abating, with the USA seeing an increase of 60% over the past 30 years. Almost 80% of all strokes are Ischemic Strokes and require emergency medical treatment, typically thrombolysis or endovascular thrombectomy. Given these alarming statistics, there is a global imperative to further improve the efficacy of current stroke treatments. Dr Gwag adds: "In 2015, fast endovascular thrombectomy was proven to improve functional outcome in acute ischemic stroke patients and is the de facto standard for stroke care across the world. It is therefore encouraging that the outcome of stroke patients is further improved by the fast administration of Nelonemdaz along with rapid thrombectomy," The prior Phase 2 SONIC trial results, published in Stroke Journal in 2022, showed the promising efficacy and safety of Nelonemdaz administered to stroke patients receiving thrombectomy. In the latest 498 patient Phase 3 RODIN Trial, administration of Nelonemdaz within 12 hours of ischemic stroke onset did not show significant efficacy in patients treated with thrombectomy. However, post-hoc analyses revealed potential interactions between treatment effects and time-related metrics. The RODIN results are to be published in the 'JAMA' (Journal of the American Medical Association) Network Open. The interactions were shown in the pooled analysis of stroke patients participating in the SONIC and RODIN trials, and in the subsequent subgroup analysis, the first infusion time of Nelonemdaz for improved functional outcome was established to be within 70 minutes from ER arrival. The efficacy of Nelonemdaz was assessed using the modified Rankin Scale (mRS), an ordinal scale ranging from 0 (normal) to 6 (death), at 12 weeks post-treatment. Compared to the placebo, the nelonemdaz caused a significantly beneficial shift in the mRS distribution (common odds ratio 2.2, p<0.05). The proportion of patients in mRS 0-2 corresponding to functional independence was 50.0% in the placebo group and improved to 68.6% in the Nelonemdaz group (p=0.059). Dr Lee adds " "Our post-hoc analyses unveiled a best clinical trial condition that showed a significant benefit of Nelonemdaz, and a protocol for the global phase 3 RENEW trial was established to confirm beneficial effects of Nelonemdaz in ischemic stroke patients in combination with endovascular thrombectomy." Dr. Lee will lead the RENEW trial alongside principal USA investigators Dr. Raul Nogueira, director of the UPMC Stroke Institute and Professor of Neurology and Dr. David S. Liebeskind, Director of the UCLA Stroke Center and Professor of Neurology. About GNT Pharma: GNT Pharma Co., Ltd ('GNTP') was founded in April 1998 by eight highly accomplished professors in subjects ranging from neuroscience and pharmacology to cell biology researching neuronal cell death. Since then, GNTP has discovered and developed an enviable pipeline of late stage drug candidates from nervous system disorders to chronic inflammatory diseases. As well as Nelonemdaz, GNTP's other flagship drug candidates include: Crisdesalazine for the treatment of Alzheimer's and neurodegenerative diseases and depression; and Flusalazine for inflammatory and respiratory diseases including COPD and Asthma. GNTP also has two commercial products in market, including Gedacure (Crisdesalazine) for the treatment of CDS or 'doggy dementia' that shares similar pathology to Alzheimers; and (2) Radipair, skin care products. Forward-Looking Statements Notice: This news release contains statements about expectations, plans, projections, and strategies of GNTP that constitute forward-looking statements to shareholders, investors, and partners. Statements included in this document that are not historical data and fact constitute forward-looking statements about future clinical and financial results. FURTHER INFORMATION: Media Inquiries: Byung Chul Kim, (M) +82-318005-9910; (E) [email protected] Investors/ Korea: Daeyong Kim, (M) +82-704261-0788; (E) [email protected] Investors /International: Sam Cho, (M) + 82-108948-7142; (E) [email protected] SOURCE GNT Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▲3月7-8日 成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据www.pharnexcloud.com监测显示：普洛药业股份有限公司发布 关于全资子公司终止注射用索法地尔 III 期临床试验的公告  。本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗漏。   普洛药业股份有限公司（以下简称“公司”）全资子公司浙江普洛家园药业有限公司（以下简称“家园药业”）研发的注射用索法地尔治疗急性缺血性脑卒中的临床研究处于 III 期临床试验阶段。近日，基于该药物目前临床研究进展及后续研发投入等因素的综合评估，公司决定终止注射用索法地尔治疗急性缺血性脑卒中的 III 期临床试验。现将有关情况公告如下：   一、终止临床的药物基本信息    1、药品名称：注射用索法地尔    2、剂型：注射剂    3、注册分类：化学药品Ⅰ类    4、适应症：急性缺血性脑卒中    5、批件号：2016L08185    二、药物研发相关情况及终止原因    注射用索法地尔是公司全资子公司家园药业开发的一种创新药物，临床试验的适应症为：急性缺血性脑卒中。家园药业于 2009 年从韩国 Neurotech 公司（现名：GNT Pharma）引进注射用索法地尔项目，具有大中华地区的自主知识产权。   公司全资子公司家园药业于 2014 年 06 月 21 日收到原国家食品药品监督管 理局签发的《药物临床试验批件》，批件号为 2014L01020，同意本品进行 I 期临 床试验。2015 年 11 月完成 I 期临床试验。2016 年 09 月收到原国家食品药品监 督管理局签发的《药物临床试验批件》，批件号为 2016L08185，同意本品继续进 行临床试验 I/II/III 期。2019 年 7 月完成 II 期临床试验，并于 2020 年 12 月启动 III 期临床试验。   经公司评估，结合 III 期临床试验运行期间全国大范围封控影响，可能导致 临床研究数据的完整性和准确性风险以及方案偏离可能引起的数据质量风险，公司决定终止该 III 期临床试验。该项临床试验的终止不影响注射用索法地尔在 GNT Pharma 的临床研究以及公司未来该项目的其他相关临床研究。 临床试验终止后，该临床试验将停止入组，已经入组的受试者将继续按照临床试验方案进行随访，已入组受试者的权益将得到充分保障。三、对公司的影响及风险提示  截至本公告日，注射用索法地尔研发投入共计 12,227.74 万元（未经审计）。按照相关会计准则和公司会计政策，注射用索法地尔的研发投入已全部费用化并计入相应会计期间损益，不会对公司本年度业绩产生重大影响。  公司一直高度重视研发创新，持续加大研发投入，严格控制研发成本，不断提高研发效率；但新药研发风险高、周期长，存在诸多不确定性。敬请广大投资者谨慎决策，注意投资风险。 特此公告。                                        普洛药业股份有限公司董事会                                               2024 年 1 月 26 日版权声明：本文转自药融投资，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  3月 • NDC x 2024新药创新者峰会  关键词：  ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

1月26日，普洛药业发布公告，称基于注射用索法地尔目前临床研究进展及后续研发投入等因素的综合评估，决定终止该产品治疗急性缺血性脑卒中的III期临床试验。索法地尔是普洛药业全资子公司家园药业开发的一种创新药物，临床试验的适应症为：急性缺血性脑卒中。家园药业于2009年从韩国Neurotech（现名：GNT Pharma）引进索法地尔项目，具有大中华地区的自主知识产权。索法地尔在2020年12月启动III期临床试验。结合III期临床试验运行期间全国大范围封控影响，可能导致临床研究数据的完整性和准确性风险以及方案偏离可能引起的数据质量风险，公司决定终止该III期临床试验。该项临床试验的终止不影响索法地尔在GNT Pharma的临床研究以及公司未来该项目的其他相关临床研究。 临床试验终止后，该临床试验将停止入组，已经入组的受试者将继续按照临床试验方案进行随访，已入组受试者的权益将得到充分保障。截至目前，索法地尔研发投入共计1.22亿元（未经审计）。Copyright © 2023 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。