{"id":6988,"date":"2022-03-10T19:35:00","date_gmt":"2022-03-10T19:35:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3688320_AE88320_0"},"modified":"2022-03-10T19:35:00","modified_gmt":"2022-03-10T19:35:00","slug":"gan-lee-pharmaceuticals-begins-first-in-human-trial-in-u-s-for-investigational-drug-gzr18","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=6988","title":{"rendered":"Gan &amp; Lee Pharmaceuticals Begins First-In-Human Trial in U.S. for Investigational Drug, GZR18"},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/en.prnasia.com\/prnasia.com-PC\/images\/logo-en-blue-in.png\" class=\"ff-og-image-inserted\"><\/div>\n<div id=\"dvContent\" readability=\"101.12656072645\">\n<p><span class=\"xn-location\">BEIJING<\/span> and <span class=\"xn-location\">BRIDGEWATER, N.J.<\/span>, <span class=\"xn-chron\">March 11, 2022<\/span> \/PRNewswire\/ &#8212; Gan &amp; Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan &amp; Lee, stock code: 603087.SH), is pleased to announce the first subject has been dosed in our Phase I, double-blinded, randomized, placebo-controlled,&nbsp;sequential, single, ascending dose clinical study in the U.S. for the company&#8217;s investigational drug, GZR18. GZR18 is a glucagon-like peptide-1 receptor agonist (GLP-1RA) with potential to treat patients with type 2 diabetes. Currently, type 2 diabetes mellitus accounts for approximately 90% of all diabetes cases while a 46% increase in the number of people with diabetes is expected by 2045, globally<sup>1<\/sup>. Glucagon-like peptide-1 (GLP-1) is an incretin hormone responsible for many glucoregulatory effects such as the stimulation of insulin secretion and the inhibition of glucagon when blood glucose is high<sup>2<\/sup>. Many of these glucoregulatory effects are often impaired in patients with type 2 diabetes<sup>3<\/sup>.<\/p>\n<p>The primary objective of this Phase 1 study is to investigate the safety and tolerability of GZR18 in healthy volunteers. In addition, the secondary objective is to determine the pharmacokinetic (PK) parameters of GZR18. &#8220;The start of this Phase 1 clinical trial of GZR18 at a U.S. site, is a significant milestone for our global clinical development program. This trial demonstrates Gan &amp; Lee&#8217;s long-term commitment to strengthening our pipeline in diabetes and other therapeutic areas to benefit the patient and medical community&#8221;&nbsp;said Dr. <span class=\"xn-person\">Mike Hu<\/span>, the Chief Executive Officer (CEO) &amp; President&nbsp;of Gan &amp; Lee Pharmaceuticals <span class=\"xn-location\">USA<\/span> Corporation.&nbsp;<\/p>\n<p><b>About Gan &amp; Lee<\/b><\/p>\n<p>Gan &amp; Lee Pharmaceuticals&nbsp;has&nbsp;developed the first Chinese domestic biosynthetic human insulin. Currently, we have&nbsp;five recombinant insulin analogs commercialized in <span class=\"xn-location\">China<\/span> including long-acting glargine injection (Basalin<sup>\u00ae<\/sup>), fast-acting lispro injection (Prandilin<sup>\u2122<\/sup>), fast-acting aspart injection (Rapilin<sup>\u00ae<\/sup>), mixed protamine zinc lispro injection (25R) (Prandilin<sup>\u00ae<\/sup>25), aspart 30 injection (Rapilin<sup>\u00ae<\/sup>30), and one human insulin injection &#8211; mixed protamine human insulin injection (30R) (Similin<sup>\u00ae<\/sup>30).&nbsp;We&nbsp;have two approved medical devices in <span class=\"xn-location\">China<\/span>, namely&nbsp;reusable insulin injection pen&nbsp;(GanleePen<sup>\u2122<\/sup>),&nbsp;and disposable pen needle (GanleeFine<sup>\u00ae<\/sup>).<\/p>\n<p>In the future, Gan &amp; Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our&nbsp;goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.&nbsp;For more information, please contact us at <a target=\"_blank\" href=\"mailto:investorrelations@ganlee.us\" rel=\"nofollow noopener\">investorrelations@ganlee.us<\/a>.<\/p>\n<p><b>References<\/b><\/p>\n<p>1.&nbsp; International Diabetes Federation. IDF Diabetes Atlas, 10th edn. <span class=\"xn-location\">Brussels, Belgium<\/span>: 2021. Available at: <u><a target=\"_blank\" href=\"https:\/\/www.diabetesatlas.org\/\" rel=\"nofollow noopener\">https:\/\/www.diabetesatlas.org<\/a><\/u><\/p>\n<p>2.&nbsp; Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes &#8211; state-of-the-art. Mol Metab. 2021 Apr; 46:101102. doi: 10.1016\/j.molmet.2020.101102. Epub 2020 Oct 14. PMID: 33068776; PMCID: PMC8085572. Available at: <u><a target=\"_blank\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK551568\/\" rel=\"nofollow noopener\">https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK551568\/<\/a><\/u><\/p>\n<p>3.&nbsp; Brunton SA, Wysham CH. GLP-1 receptor agonists in the treatment of type 2 diabetes: role and clinical experience to date. Postgrad Med. 2020 Nov;132(sup2):3-14. doi: 10.1080\/00325481.2020.1798099. Epub 2020 <span class=\"xn-chron\">Sep 8<\/span>. PMID: 32815454.<\/p>\n<p>Media Contacts: <span class=\"xn-person\">Gina Antonucci<\/span>, #: 888-288-5395, <a href=\"mailto:investorrelations@ganlee.us%C2%A0\" rel=\"nofollow\">investorrelations@ganlee.us&nbsp;<\/a><\/p>\n<\/p><\/div>\n<p>Source: Gan &amp; Lee Pharmaceuticals Co., Ltd.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BEIJING and BRIDGEWATER, N.J., March 11, 2022 \/PRNewswire\/ &#8212; Gan &amp; Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan &amp; Lee, stock code: 603087.SH), is pleased to announce the first subject has been dosed in our Phase I, double-blinded, randomized, placebo-controlled,&nbsp;sequential, single, ascending dose clinical study in the U.S. for the company&#8217;s investigational drug, [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":6989,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-6988","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gan &amp; Lee Pharmaceuticals Begins First-In-Human Trial in U.S. for Investigational Drug, GZR18 - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=6988\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gan &amp; Lee Pharmaceuticals Begins First-In-Human Trial in U.S. for Investigational Drug, GZR18 - My Blog\" \/>\n<meta property=\"og:description\" content=\"BEIJING and BRIDGEWATER, N.J., March 11, 2022 \/PRNewswire\/ &#8212; Gan &amp; Lee Pharmaceuticals Co., Ltd. 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