{"id":4031,"date":"2020-09-07T11:26:00","date_gmt":"2020-09-07T03:26:00","guid":{"rendered":"https:\/\/uni-pharma.com.tw\/the-company-and-genya-biotechnology-co-ltd-jointly-developed-a-new-drug-for-the-treatment-of-lupus-erythematosus-gv17-and-submitted-a-pre-ind-meeting-application-to-the-u-s-fda\/"},"modified":"2025-03-13T18:26:26","modified_gmt":"2025-03-13T10:26:26","slug":"the-company-and-genya-biotechnology-co-ltd-jointly-developed-a-new-drug-for-the-treatment-of-lupus-erythematosus-gv17-and-submitted-a-pre-ind-meeting-application-to-the-u-s-fda","status":"publish","type":"post","link":"https:\/\/uni-pharma.com.tw\/en\/the-company-and-genya-biotechnology-co-ltd-jointly-developed-a-new-drug-for-the-treatment-of-lupus-erythematosus-gv17-and-submitted-a-pre-ind-meeting-application-to-the-u-s-fda\/","title":{"rendered":"The company and Genya Biotechnology Co., Ltd. jointly developed a new drug for the treatment of lupus erythematosus, GV17, and submitted a pre-IND meeting application to the U.S. FDA"},"content":{"rendered":"\n<p>The company and Genya Biotechnology Co., Ltd. jointly developed a new drug for the treatment of lupus erythematosus, GV17, and submitted a pre-IND meeting application to the US FDA, and received a reply recently; Suggestions on the design of clinical trials such as preclinical and clinical trial data and efficacy indicators that should be provided before IND and NDA.<\/p>\n\n<p>The main ingredient of GV17 is hydroxyquinine (HCQ), which is an important drug for the treatment of lupus erythematosus and chronic rheumatoid arthritis.<\/p>\n\n<p>GV17 is a right-handed optical isomer of HCQ [(S)-(+)HCQ], which has been shown by the literature and the research completed by the Company in collaboration with Genya, which has a better safety profile for patients taking long-term medication, and has the advantages of smaller blood concentration fluctuations, longer efficacy and lower side effects compared with commercially available products. The development of GV17 is based on a patented preparation method to manufacture (S)-(+)HCQ crystal form raw materials, and then to develop new drugs for formulations and indications.<\/p>\n\n<figure class=\"wp-block-image size-full\"><img data-recalc-dims=\"1\" decoding=\"async\" src=\"https:\/\/i0.wp.com\/uni-pharma.com.tw\/wp-content\/uploads\/2024\/11\/%E8%B2%A1%E8%A8%8A%E6%96%B0%E8%81%9E-%E3%80%90%E5%85%AC%E5%91%8A%E3%80%91%E5%81%A5%E4%BA%9E%E6%B2%BB%E7%99%82%E7%B4%85%E6%96%91%E7%8B%BC%E7%98%A1%E6%96%B0%E8%97%A5GV17%EF%BC%8C%E6%8E%A5%E7%8D%B2%E7%BE%8E%E5%9C%8BFDA%E4%B9%8Bpre-INDmeeting%E5%9B%9E%E8%A6%86.png?w=1440&#038;ssl=1\" alt=\"Central News Agency [Announcement] Jianya's new drug for the treatment of lupus erythematosus, GV17, received a reply from the US FDA's Pre Indmeeting\" class=\"wp-image-3071\"\/><figcaption class=\"wp-element-caption\">Central News Agency [Announcement] Jianya&#8217;s new drug for the treatment of lupus erythematosus, GV17, received a reply from the US FDA&#8217;s Pre Indmeeting<\/figcaption><\/figure>\n\n<p>Original News: <a href=\"https:\/\/tw.stock.yahoo.com\/news\/%E5%85%AC%E5%91%8A-%E5%81%A5%E4%BA%9E%E6%B2%BB%E7%99%82%E7%B4%85%E6%96%91%E7%8B%BC%E7%98%A1%E6%96%B0%E8%97%A5gv17-%E6%8E%A5%E7%8D%B2%E7%BE%8E%E5%9C%8Bfda%E4%B9%8Bpre-indmeeting%E5%9B%9E%E8%A6%86-092338132.html\" target=\"_blank\" rel=\"noopener\">https:\/\/tw.stock.yahoo.com\/news\/ %E5%85%AC%E5%91%8A-E5 81%A5%E4%BA%9E%E5% %E6%B2%BB%E7%99%82%E7%B4% 85%E6%96%91%E7%8B%BC%E7%98%A1%E6%96%B0%E8%97%A5gv17-%E6%8E%A5%E7%8D%B2%E7%BE% 8E%E5%9C%8Bfda%E4%B9%8Bpre-indmeeting%E5%9B%9E%E8%A6%86-092338132.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The company and Genya Biotechnology Co., Ltd. jointly developed a new drug for the treatment of lupus erythematosus, GV17, and submitted a pre-IND meeting application to the US FDA, and received a reply recently; Suggestions on the design of clinical trials such as preclinical and clinical trial data and efficacy indicators that should be provided [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3685,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[187,188],"tags":[],"class_list":["post-4031","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-whats-new","category-industry-news"],"blocksy_meta":[],"acf":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/uni-pharma.com.tw\/wp-content\/uploads\/2024\/11\/%E8%B2%A1%E8%A8%8A%E6%96%B0%E8%81%9E-%E4%B8%AD%E5%A4%AE%E7%A4%BE-2020.9.7.png?fit=1628%2C958&ssl=1","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgrulY-131","_links":{"self":[{"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/posts\/4031","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/comments?post=4031"}],"version-history":[{"count":2,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/posts\/4031\/revisions"}],"predecessor-version":[{"id":4035,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/posts\/4031\/revisions\/4035"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/media\/3685"}],"wp:attachment":[{"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/media?parent=4031"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/categories?post=4031"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uni-pharma.com.tw\/en\/wp-json\/wp\/v2\/tags?post=4031"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}