{"id":23311,"date":"2022-12-28T23:26:00","date_gmt":"2022-12-28T15:26:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23311"},"modified":"2025-01-26T23:29:09","modified_gmt":"2025-01-26T15:29:09","slug":"luye-pharmas-paliperidone-palmitate-accepted-for-nmpa-review","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23311","title":{"rendered":"Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review"},"content":{"rendered":"\n

China-based Luye Pharma Group (HKG: 2186<\/a>) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for marketing in China.<\/p>\n\n\n\n

Clinical Study and Regulatory Progress<\/strong>
A pivotal clinical study for LY03010 has recently reached expected endpoints, paving the way for a New Drug Application (NDA) filing via the 505 (b)(2) channel in the US. This marks a significant step forward in the global development of LY03010, highlighting Luye Pharma’s commitment to addressing significant unmet medical needs in schizophrenia treatment.<\/p>\n\n\n\n

Drug Profile and Patient Benefits<\/strong>
Paliperidone palmitate is a second-generation antipsychotic drug suitable for single monthly dosage by intramuscular injection. It is indicated for the treatment of schizophrenia and schizoaffective disorders. The drug can improve compliance issues that often affect oral antipsychotic drugs in patients with schizophrenia, including by optimizing the initial dosing regimen. This innovative approach aims to enhance patient outcomes and quality of life.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone…<\/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":false,"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":[87,1023,219,38],"class_list":["post-23311","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-chronic-disease","tag-hkg-2186","tag-luye-pharma","tag-market-approval-filings"],"yoast_head":"\nLuye Pharma's Paliperidone Palmitate Accepted for NMPA Review - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for marketing in China.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=23311\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Luye Pharma's Paliperidone Palmitate Accepted for NMPA Review\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=23311\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2022-12-28T15:26:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-26T15:29:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=23311#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=23311\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review\",\"datePublished\":\"2022-12-28T15:26:00+00:00\",\"dateModified\":\"2025-01-26T15:29:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=23311\"},\"wordCount\":190,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Chronic disease\",\"HKG: 2186\",\"Luye Pharma\",\"Market approval filings\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=23311#respond\"]}],\"copyrightYear\":\"2022\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=23311\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=23311\",\"name\":\"Luye Pharma's Paliperidone Palmitate Accepted for NMPA Review - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2022-12-28T15:26:00+00:00\",\"dateModified\":\"2025-01-26T15:29:09+00:00\",\"description\":\"China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for marketing in China.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=23311#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=23311\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=23311#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review\"}]},{\"@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\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Luye Pharma's Paliperidone Palmitate Accepted for NMPA Review - Insight, China's Pharmaceutical Industry","description":"China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for marketing in China.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=23311","og_locale":"en_US","og_type":"article","og_title":"Luye Pharma's Paliperidone Palmitate Accepted for NMPA Review","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=23311","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2022-12-28T15:26:00+00:00","article_modified_time":"2025-01-26T15:29:09+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=23311#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=23311"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review","datePublished":"2022-12-28T15:26:00+00:00","dateModified":"2025-01-26T15:29:09+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=23311"},"wordCount":190,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Chronic disease","HKG: 2186","Luye Pharma","Market approval filings"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=23311#respond"]}],"copyrightYear":"2022","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=23311","url":"https:\/\/flcube.com\/?p=23311","name":"Luye Pharma's Paliperidone Palmitate Accepted for NMPA Review - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2022-12-28T15:26:00+00:00","dateModified":"2025-01-26T15:29:09+00:00","description":"China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for marketing in China.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=23311#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=23311"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=23311#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review"}]},{"@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\/23311","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=23311"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/23311\/revisions"}],"predecessor-version":[{"id":23312,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/23311\/revisions\/23312"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=23311"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=23311"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=23311"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}