{"id":68015,"date":"2026-06-11T20:58:55","date_gmt":"2026-06-11T12:58:55","guid":{"rendered":"https:\/\/flcube.com\/?p=68015"},"modified":"2026-06-11T20:58:56","modified_gmt":"2026-06-11T12:58:56","slug":"yipinhong-pharmacy-receives-nmpa-clearance-for-aph03571-dual-mechanism-therapy-in-flt3-mutated-relapsed-refractory-aml","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68015","title":{"rendered":"Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed\/Refractory AML"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Yipinhong Pharmacy Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/300723:SHE\">SHE: 300723<\/a>) announced it has received <strong>Investigational New Drug (IND) clearance from China&#8217;s National Medical Products Administration (NMPA)<\/strong> to initiate a <strong>clinical study<\/strong> evaluating <strong>APH03571<\/strong>, a novel <strong>dual-mechanism therapeutic agent<\/strong>, in adult patients with <strong>relapsed or refractory acute myeloid leukemia (AML)<\/strong> harboring <strong>FLT3 mutations<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-amp-development-milestone\" class=\"wp-block-heading\">Regulatory &amp; Development Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Yipinhong Pharmacy Co., Ltd. (SHE: 300723)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>APH03571<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Dual-mechanism agent (FLT3 inhibitor + IRAK4 degrader)<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>IND clearance for clinical investigation<\/td><\/tr><tr><td><strong>Target Population<\/strong><\/td><td>Adult patients with relapsed\/refractory AML harboring FLT3 mutations<\/td><\/tr><tr><td><strong>Development Stage<\/strong><\/td><td>Clinical trial initiation<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>11 Jun 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual Mechanism:<\/strong> Simultaneous FLT3 kinase inhibition and IRAK4 protein degradation<\/li>\n\n\n\n<li><strong>Primary Target:<\/strong> FLT3 (FMS-like tyrosine kinase 3) &#8211; frequently mutated in AML and associated with poor prognosis<\/li>\n\n\n\n<li><strong>Secondary Target:<\/strong> IRAK4 (Interleukin-1 receptor-associated kinase 4) &#8211; key mediator of inflammatory signaling in leukemic cells<\/li>\n\n\n\n<li><strong>Therapeutic Rationale:<\/strong> Addresses both oncogenic driver mutations (FLT3) and inflammatory survival pathways (IRAK4) that contribute to treatment resistance<\/li>\n\n\n\n<li><strong>Preclinical Evidence:<\/strong> Dose-dependent tumor growth inhibition and prolonged survival in mouse xenograft models of FLT3-mutated AML<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">FLT3 mutations occur in approximately 30% of AML cases and are associated with high relapse rates and poor overall survival. Current FLT3 inhibitors often face limitations due to acquired resistance and compensatory signaling through alternative pathways. APH03571&#8217;s dual-targeting approach aims to overcome these challenges by simultaneously blocking the primary oncogenic driver while disrupting inflammatory survival signals mediated by IRAK4.<\/p>\n\n\n\n<h2 id=\"h-market-opportunity-amp-competitive-landscape\" class=\"wp-block-heading\">Market Opportunity &amp; Competitive Landscape<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>AML Patient Population:<\/strong> Estimated 8,000-10,000 new FLT3-mutated AML cases annually in China<\/li>\n\n\n\n<li><strong>Relapsed\/Refractory Segment:<\/strong> Represents approximately 40-50% of FLT3-mutated AML patients with limited treatment options<\/li>\n\n\n\n<li><strong>Competitive Differentiation:<\/strong> First-in-class dual FLT3 inhibitor\/IRAK4 degrader mechanism; addresses key unmet need in treatment-resistant AML<\/li>\n\n\n\n<li><strong>Current Therapies:<\/strong> Competes against established FLT3 inhibitors (midostaurin, gilteritinib, quizartinib) but offers potential advantages in overcoming resistance<\/li>\n\n\n\n<li><strong>Pricing Potential:<\/strong> Expected premium pricing reflecting innovative mechanism and addressable unmet need; estimated RMB 150,000-200,000 per treatment course<\/li>\n\n\n\n<li><strong>Development Timeline:<\/strong> Phase I\/II trial expected to complete by Q2 2028, with potential accelerated approval pathway given high unmet medical need<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The IND clearance positions Yipinhong as an emerging player in targeted oncology therapeutics and validates the company&#8217;s dual-mechanism drug discovery platform for addressing complex resistance mechanisms in hematological malignancies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory pathways, and market opportunities. Actual outcomes may differ due to clinical trial results, regulatory decisions, and competitive developments inherent in oncology drug development.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/\u4e00\u54c1\u7ea2\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u521b\u65b0\u836fAPH03571\u7247\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u4e00\u54c1\u7ea2\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u521b\u65b0\u836fAPH03571\u7247\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-3781c51b-21fd-4042-aa28-19b4b202f0fd\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/\u4e00\u54c1\u7ea2\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u521b\u65b0\u836fAPH03571\u7247\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\">\u4e00\u54c1\u7ea2\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u521b\u65b0\u836fAPH03571\u7247\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/\u4e00\u54c1\u7ea2\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u521b\u65b0\u836fAPH03571\u7247\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3781c51b-21fd-4042-aa28-19b4b202f0fd\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[62,1126,370],"class_list":["post-68015","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-she-300723","tag-yipinhong-pharmacy"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed\/Refractory AML - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Yipinhong Pharmacy Co., Ltd. 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(SHE: 300723) announced it has received Investigational New Drug (IND) clearance from China's National Medical Products Administration (NMPA) to initiate a clinical study evaluating APH03571, a novel dual-mechanism therapeutic agent, in adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=68015#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=68015"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=68015#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed\/Refractory AML"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/68015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=68015"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/68015\/revisions"}],"predecessor-version":[{"id":68017,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/68015\/revisions\/68017"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=68015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=68015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=68015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}