{"id":8278,"date":"2026-09-18T15:29:40","date_gmt":"2026-09-18T07:29:40","guid":{"rendered":"https:\/\/wccbiomedical.com\/?p=8278"},"modified":"2026-09-18T16:42:05","modified_gmt":"2026-09-18T08:42:05","slug":"wcc-biomedicals-wcc-301-clears-fda-review-phase-1-2-clinical-trial-set-to-begin","status":"publish","type":"post","link":"https:\/\/wccbiomedical.com\/en\/news\/wcc-biomedicals-wcc-301-clears-fda-review-phase-1-2-clinical-trial-set-to-begin\/","title":{"rendered":"WCC Biomedical&#8217;s WCC-301 Clears FDA Review \u2014 Phase 1\/2 Clinical Trial Set to Begin"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8278\" class=\"elementor elementor-8278\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f2969f8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f2969f8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-966dd48\" data-id=\"966dd48\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-94d8ad8 elementor-widget elementor-widget-image\" data-id=\"94d8ad8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2560\" height=\"1429\" src=\"https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-scaled.jpg\" class=\"attachment-full size-full wp-image-8289\" alt=\"\" srcset=\"https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-scaled.jpg 2560w, https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-300x167.jpg 300w, https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-1024x572.jpg 1024w, https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-768x429.jpg 768w, https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-1536x857.jpg 1536w, https:\/\/wccbiomedical.com\/wp-content\/uploads\/2026\/09\/Gemini_Generated_Image_sve1upsve1upsve1-2048x1143.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4686a34 elementor-widget elementor-widget-text-editor\" data-id=\"4686a34\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>WCC Biomedical today announced a major milestone: the company&#8217;s <b>Investigational New Drug (IND) application for WCC-301, a combined Phase 1\/2 clinical trial, has passed FDA review.<\/b> This clears the way for the Phase 1\/2 trial, to be conducted in Taiwan, to move forward.<\/p><p>WCC-301 is a lead pipeline candidate built on WCC Biomedical&#8217;s own <strong>WINMAP\u2122 Microarray Patch technology<\/strong> \u2014 a platform the company has spent years developing to deliver drugs through the skin using dissolvable microneedles instead of traditional injections or oral dosing.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c661bf elementor-widget elementor-widget-heading\" data-id=\"7c661bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">A Real Gap in the Global Pain-Relief Market<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-112d0b9 elementor-widget elementor-widget-text-editor\" data-id=\"112d0b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>According to IQVIA, the global market for non-steroidal anti-inflammatory drugs (NSAIDs) reached roughly NT$300 billion in 2025. Clinical guidelines from the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) already recommend topical NSAIDs as the first-line treatment for acute musculoskeletal pain outside the lower back, and advise avoiding opioids where possible, noting that topical NSAIDs are the only option shown to improve outcomes across every measure studied.<\/p><p>WCC-301&#8217;s Phase 1 trial will focus on <strong>ankle sprains<\/strong>, one of the most common acute soft-tissue injuries. Most patients are sent home to care for themselves after an ER visit, and there&#8217;s real demand for a pain-relief option that&#8217;s simple to use and easy to dose correctly, <strong>exactly what WCC-301 is designed to be.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-372ace7 elementor-widget elementor-widget-heading\" data-id=\"372ace7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Small Patch, Big Difference<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6943d2b elementor-widget elementor-widget-text-editor\" data-id=\"6943d2b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Compared to the pain patches on the market today, WCC-301 looks and feels different \u2014 closer to a small biochip than a traditional medicated patch:<\/p><ul><li>Just 1.5 cm across \u2014 about 1\/50th the size of a standard pain patch<\/li><li>Worn for only 5 minutes before it&#8217;s removed<\/li><li>A cooling effect right at the inflamed area on application<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf74119 elementor-widget elementor-widget-heading\" data-id=\"bf74119\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">A Clear Regulatory Strategy: the 505(b)(2) Pathway<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f30e46a elementor-widget elementor-widget-text-editor\" data-id=\"f30e46a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>WCC Biomedical is taking a deliberate approach with <strong>WCC-301: pairing a well-established drug with a clear, well-understood indication, in order to validate a delivery technology that regulators are still building precedent for.<\/strong><\/p><p>&#8220;Completing the US IND filing for WCC-301 is a key step for our WINMAP\u2122 platform \u2014 moving from technology development into clinical development,&#8221; said Dr. Ta-Jo Liu, Chairman of WCC Biomedical. &#8220;Microneedle technology has been in development for years, and microneedle devices have already received medical device clearance \u2014 but no microneedle array patch has ever received new drug approval. Our goal is to make the microneedle array patch a true, approved new drug dosage form. Choosing the 505(b)(2) pathway and the sprain indication is the most practical way to validate that path.&#8221;<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f21b58 elementor-widget elementor-widget-heading\" data-id=\"3f21b58\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Momentum Behind the Milestone<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d5688e4 elementor-widget elementor-widget-text-editor\" data-id=\"d5688e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>WCC Biomedical was invited to give <strong>four presentations at the 2025 PATH Microneedle Conference, covering WCC-301, mRNA vaccine microneedle patch development, the WINMAP\u2122 mini platform, and an overview of the company&#8217;s technology.<\/strong> The company has also <strong>won the Moderna Taiwan mRNA Frontier Innovation Award \u2014 co-organized by Moderna Taiwan and Academia Sinica \u2014 in back-to-back years, 2024 and 2025.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8acc49e elementor-widget elementor-widget-heading\" data-id=\"8acc49e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What's Next<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ccb15a7 elementor-widget elementor-widget-text-editor\" data-id=\"ccb15a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>WCC Biomedical will also file a clinical trial application with Taiwan&#8217;s Food and Drug Administration (TFDA), the next regulatory step toward bringing the Phase 1\/2 trial to Taiwan.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9a6d1de elementor-widget elementor-widget-text-editor\" data-id=\"9a6d1de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>For more details check out the Economic Daily Article: <a href=\"https:\/\/money.udn.com\/money\/story\/123828\/9754669\" target=\"_blank\" rel=\"noopener\">Click Here<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9168ca7 elementor-widget elementor-widget-heading\" data-id=\"9168ca7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">About WCC Biomedical<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b15ca32 elementor-widget elementor-widget-text-editor\" data-id=\"b15ca32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>WCC Biomedical is dedicated to developing microneedle array patch (MAP) transdermal drug delivery technology. Through its proprietary WINMAP\u2122 platform, the company advances new drug development and technology licensing, and has built its own microneedle manufacturing process and quality systems in-house. WCC Biomedical is the first company in Taiwan to be recognized as a &#8220;Biotech Pharmaceutical Company&#8221; by Taiwan&#8217;s Ministry of Economic Affairs on the strength of an innovative technology platform, and continues to partner with research institutions and industry partners at home and abroad.<\/p><p>Note: This announcement concerns clinical trial authorization, not a marketing or drug approval. Forward-looking statements about future development plans and timelines are not guarantees of future results; actual outcomes may differ due to regulatory review, clinical trial execution, partnership arrangements, and other factors.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>WCC Biomedical today announced a major milestone: the company&#8217;s Investigational New Drug (IND) application for WCC-301, a combined Phase 1\/2 clinical trial, has passed FDA review. This clears the way for the Phase 1\/2 trial, to be conducted in Taiwan, to move forward. WCC-301 is a lead pipeline candidate built on WCC Biomedical&#8217;s own WINMAP\u2122 [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":8281,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ocean_front_end_style_editor":"no","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"","ocean_second_sidebar":"","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"","ocean_custom_header_template":"","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","ofc_enable_fullscreen":"disable","ofc_fullscreen_speed":0,"ofc_fullscreen_nav":"enable","ofc_fullscreen_nav_pos":"right","ofc_fullscreen_nav_color":"","ofc_fullscreen_nav_tooltip_color":"","ofc_fullscreen_responsive":0,"osp_disable_panel":"default","osh_disable_topbar_sticky":"default","osh_disable_header_sticky":"default","osh_sticky_header_style":"default","osh_sticky_header_effect":"","osh_custom_sticky_logo":0,"osh_custom_retina_sticky_logo":0,"osh_custom_sticky_logo_height":0,"osh_background_color":"","osh_links_color":"","osh_links_hover_color":"","osh_links_active_color":"","osh_links_bg_color":"","osh_links_hover_bg_color":"","osh_links_active_bg_color":"","osh_menu_social_links_color":"","osh_menu_social_hover_links_color":"","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"on","ocean_gallery_id":[],"footnotes":""},"categories":[67],"tags":[],"class_list":["post-8278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","entry","has-media"],"acf":[],"categories_names":["News"],"post_class":[["post-8278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","entry","has-media"]],"author_avatar":["<img alt='' src='https:\/\/secure.gravatar.com\/avatar\/e66a33020d155c7954d542bb2f3204018638b721ff77d4b751dc41b902e60bed?s=96&#038;d=mm&#038;r=g' srcset='https:\/\/secure.gravatar.com\/avatar\/e66a33020d155c7954d542bb2f3204018638b721ff77d4b751dc41b902e60bed?s=192&#038;d=mm&#038;r=g 2x' class='avatar avatar-96 photo' height='96' width='96' decoding='async'\/>"],"featured_video":null,"permalink_manager":null,"_links":{"self":[{"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/posts\/8278","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/comments?post=8278"}],"version-history":[{"count":5,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/posts\/8278\/revisions"}],"predecessor-version":[{"id":8297,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/posts\/8278\/revisions\/8297"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/media\/8281"}],"wp:attachment":[{"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/media?parent=8278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/categories?post=8278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wccbiomedical.com\/en\/wp-json\/wp\/v2\/tags?post=8278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}