{"id":75314,"date":"2026-08-19T12:27:45","date_gmt":"2026-08-19T04:27:45","guid":{"rendered":"https:\/\/flcube.com\/?p=75314"},"modified":"2026-08-19T12:27:46","modified_gmt":"2026-08-19T04:27:46","slug":"nhwa-pharmaceutical-wins-nmpa-ind-approval-for-two-category-1-chemical-drugs-nh130-for-schizophrenia-alzheimers-psychosis-nh302-for-acute-pain","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=75314","title":{"rendered":"Nhwa Pharmaceutical Wins NMPA IND Approval for Two Category 1 Chemical Drugs \u2013 NH130 for Schizophrenia &amp; Alzheimer&#8217;s Psychosis, NH302 for Acute Pain"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Nhwa Pharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/002262:SHE\">SHE: 002262<\/a>) announced that its two <strong>Category 1 chemical drugs<\/strong>, <strong>NH130<\/strong> and <strong>NH302<\/strong>, have received <strong>Investigational New Drug (IND) approvals<\/strong> from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong>, clearing the path for clinical trials of both candidates.<\/p>\n\n\n\n<h2 id=\"h-ind-approval-summary\" class=\"wp-block-heading\">IND Approval Summary<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>NH130 (citrate)<\/th><th>NH302<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Category<\/strong><\/td><td>Category 1 chemical drug<\/td><td>Category 1 chemical drug<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>5\u2011HT2A receptor <strong>inverse agonist<\/strong><\/td><td>Peripherally selective <strong>kappa opioid receptor agonist<\/strong><\/td><\/tr><tr><td><strong>Target Indications<\/strong><\/td><td>Schizophrenia; Alzheimer&#8217;s disease psychosis (ADP)<\/td><td>Acute pain<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>IND approved by NMPA<\/td><td>IND approved by NMPA<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>18 Aug 2026<\/td><td>18 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-nh130-citrate\" class=\"wp-block-heading\">Drug Profile \u2013 NH130 Citrate<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Potent 5\u2011HT2A receptor inverse agonist<\/strong> intended for schizophrenia and <strong>Alzheimer&#8217;s disease psychosis (ADP)<\/strong><\/li>\n\n\n\n<li><strong>Preclinical Efficacy:<\/strong> Demonstrated effectiveness in animal models of <strong>schizophrenia and ADP without impairing motor function<\/strong><\/li>\n\n\n\n<li><strong>Safety Profile:<\/strong> Minimal adverse effects such as <strong>cardiotoxicity and phospholipidosis<\/strong><\/li>\n\n\n\n<li><strong>Additional Advantages:<\/strong> Wide safety window and favorable pharmacokinetic properties<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-drug-profile-nh302\" class=\"wp-block-heading\">Drug Profile \u2013 NH302<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Peripherally selective kappa opioid receptor agonist<\/strong> intended for <strong>acute pain<\/strong><\/li>\n\n\n\n<li><strong>Preclinical Efficacy:<\/strong> Strong agonistic activity at kappa receptors with <strong>marked analgesic efficacy across multiple animal pain models<\/strong><\/li>\n\n\n\n<li><strong>Differentiators:<\/strong> <strong>Low effective dose<\/strong>, <strong>long duration of action<\/strong>, and a <strong>broad safety margin against sedation<\/strong><\/li>\n\n\n\n<li><strong>Positioning:<\/strong> Acute pain therapy with significant clinical advantages, with peripheral selectivity potentially limiting central opioid\u2011related liabilities<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>CNS Portfolio Expansion:<\/strong> The dual IND approvals reinforce <strong>Nhwa Pharmaceutical&#8217;s<\/strong> positioning in central nervous system drug development, spanning psychosis and pain \u2014 two areas of high unmet need in China&#8217;s aging society.<\/li>\n\n\n\n<li><strong>Addressing Alzheimer&#8217;s Psychosis:<\/strong> ADP currently has limited approved treatment options globally; NH130&#8217;s motor\u2011function\u2011sparing profile and wide safety window could address a key limitation of existing antipsychotics in elderly patients.<\/li>\n\n\n\n<li><strong>Non\u2011Sedating Pain Option:<\/strong> NH302&#8217;s peripheral kappa selectivity and broad safety margin against sedation position it as a potential alternative to centrally acting opioids for acute pain \u2014 a segment facing intense regulatory and safety scrutiny.<\/li>\n\n\n\n<li><strong>Watch Items:<\/strong> First\u2011in\u2011human trial design and enrollment timelines for both assets, emerging safety\/efficacy readouts, and potential partnering interest given the global demand for differentiated CNS assets.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development, regulatory outcomes, and commercial expectations for NH130 and NH302. Actual results may differ due to risks including early\u2011stage clinical uncertainty, regulatory decisions, and competitive dynamics.<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\/08\/\u6069\u534e\u836f\u4e1a\uff1a\u5173\u4e8e\u6536\u52301\u7c7b\u521b\u65b0\u836fNH302\u6ce8\u5c04\u6db2\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u6069\u534e\u836f\u4e1a\uff1a\u5173\u4e8e\u6536\u52301\u7c7b\u521b\u65b0\u836fNH302\u6ce8\u5c04\u6db2\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-dd972c0b-9176-4863-a063-81748d958706\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u6069\u534e\u836f\u4e1a\uff1a\u5173\u4e8e\u6536\u52301\u7c7b\u521b\u65b0\u836fNH302\u6ce8\u5c04\u6db2\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\">\u6069\u534e\u836f\u4e1a\uff1a\u5173\u4e8e\u6536\u52301\u7c7b\u521b\u65b0\u836fNH302\u6ce8\u5c04\u6db2\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u6069\u534e\u836f\u4e1a\uff1a\u5173\u4e8e\u6536\u52301\u7c7b\u521b\u65b0\u836fNH302\u6ce8\u5c04\u6db2\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-dd972c0b-9176-4863-a063-81748d958706\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nhwa Pharmaceutical Co., Ltd. (SHE: 002262) announced that its two Category 1 chemical drugs, NH130&#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":[62,1472,1471],"class_list":["post-75314","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-nhwa-pharmaceutical","tag-she-002262"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Nhwa Pharmaceutical Wins NMPA IND Approval for Two Category 1 Chemical Drugs \u2013 NH130 for Schizophrenia &amp; Alzheimer&#039;s Psychosis, NH302 for Acute Pain - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Nhwa Pharmaceutical Co., Ltd. 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