{"id":62645,"date":"2026-04-08T21:15:59","date_gmt":"2026-04-08T13:15:59","guid":{"rendered":"https:\/\/flcube.com\/?p=62645"},"modified":"2026-04-08T21:16:00","modified_gmt":"2026-04-08T13:16:00","slug":"haisco-pharmaceutical-secures-nmpa-breakthrough-therapy-designation-for-hsk39004-inhalation-powder-in-copd-following-successful-phase-ii-lung-function-data","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=62645","title":{"rendered":"Haisco Pharmaceutical Secures NMPA Breakthrough Therapy Designation for HSK39004 Inhalation Powder in COPD, Following Successful Phase II Lung Function Data"},"content":{"rendered":"\n<p><strong>Haisco Pharmaceutical Group Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/002653:SHE\">SHE: 002653<\/a>)<\/strong> announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has granted <strong>Breakthrough Therapy Designation (BTD)<\/strong> for <strong>HSK39004 inhalation powder<\/strong> for the treatment of <strong>chronic obstructive pulmonary disease (COPD)<\/strong>. The designation follows successful completion of two Phase II studies demonstrating significant lung function improvements and favorable safety profile after four weeks of continuous dosing.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone-amp-clinical-data\">Regulatory Milestone &amp; Clinical Data<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Haisco Pharmaceutical Group Co., Ltd (SHE: 002653)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HSK39004 inhalation powder<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Novel targeted small-molecule inhibitor<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Chronic obstructive pulmonary disease (COPD)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NMPA Breakthrough Therapy Designation (April 2026)<\/td><\/tr><tr><td><strong>Clinical Stage<\/strong><\/td><td>Two completed Phase II studies<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>All met across both Phase II trials<\/td><\/tr><tr><td><strong>Key Efficacy Measure<\/strong><\/td><td>Significant lung function improvement vs. placebo at 4 weeks<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-trial-results\">Clinical Trial Results<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-phase-ii-efficacy-outcomes\">Phase II Efficacy Outcomes<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Lung Function Improvement<\/strong>: Statistically significant enhancement in primary lung function endpoints versus placebo<\/li>\n\n\n\n<li><strong>Dosing Duration<\/strong>: Four weeks of continuous administration demonstrated sustained efficacy<\/li>\n\n\n\n<li><strong>Magnitude of Effect<\/strong>: Clinically meaningful improvements in respiratory function measures<\/li>\n\n\n\n<li><strong>Consistency<\/strong>: Positive results replicated across two separate Phase II studies<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-safety-amp-tolerability-profile\">Safety &amp; Tolerability Profile<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Overall Safety<\/strong>: Good safety profile with no major safety concerns identified<\/li>\n\n\n\n<li><strong>Tolerability<\/strong>: Well-tolerated by COPD patients with manageable adverse event profile<\/li>\n\n\n\n<li><strong>Inhalation Delivery<\/strong>: Powder formulation demonstrated acceptable local tolerability<\/li>\n\n\n\n<li><strong>Systemic Exposure<\/strong>: Limited systemic absorption consistent with targeted pulmonary delivery<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-breakthrough-therapy-designation-benefits\">Breakthrough Therapy Designation Benefits<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-advantages\">Regulatory Advantages<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Accelerated Review<\/strong>: Priority review pathway with enhanced regulatory interaction<\/li>\n\n\n\n<li><strong>Development Support<\/strong>: Increased NMPA guidance throughout remaining clinical development<\/li>\n\n\n\n<li><strong>Rolling Submission<\/strong>: Potential for rolling NDA submission to accelerate approval timeline<\/li>\n\n\n\n<li><strong>Market Exclusivity<\/strong>: Potential for extended market protection upon approval<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-development-timeline-impact\">Development Timeline Impact<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase III Acceleration<\/strong>: Expedited initiation of pivotal Phase III trials<\/li>\n\n\n\n<li><strong>Approval Pathway<\/strong>: Potential for accelerated approval based on Phase II data strength<\/li>\n\n\n\n<li><strong>Commercial Launch<\/strong>: Earlier market entry compared to standard regulatory pathway<\/li>\n\n\n\n<li><strong>Competitive Advantage<\/strong>: First-mover potential in novel COPD mechanism class<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-therapeutic-rationale-amp-market-opportunity\">Therapeutic Rationale &amp; Market Opportunity<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-copd-treatment-landscape\">COPD Treatment Landscape<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>High Unmet Need<\/strong>: COPD affects over 100 million people in China alone with limited treatment options<\/li>\n\n\n\n<li><strong>Current Standards<\/strong>: Reliance on bronchodilators and corticosteroids with suboptimal efficacy<\/li>\n\n\n\n<li><strong>Disease Burden<\/strong>: Leading cause of morbidity and mortality with significant healthcare costs<\/li>\n\n\n\n<li><strong>Novel Mechanisms<\/strong>: High demand for targeted therapies addressing underlying disease pathways<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-hsk39004-differentiation\">HSK39004 Differentiation<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Novel Target<\/strong>: First-in-class or best-in-class potential as targeted small-molecule inhibitor<\/li>\n\n\n\n<li><strong>Inhalation Delivery<\/strong>: Direct pulmonary delivery maximizing local efficacy while minimizing systemic effects<\/li>\n\n\n\n<li><strong>Oral Alternative<\/strong>: Powder formulation provides alternative to nebulized or metered-dose inhalers<\/li>\n\n\n\n<li><strong>Combination Potential<\/strong>: Suitable for combination with existing COPD therapies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-amp-commercial-outlook\">Strategic Implications &amp; Commercial Outlook<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-haisco-s-respiratory-franchise\">Haisco&#8217;s Respiratory Franchise<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline Leadership<\/strong>: Establishes Haisco as innovator in respiratory therapeutics<\/li>\n\n\n\n<li><strong>Technology Platform<\/strong>: Validates internal drug discovery and inhalation formulation capabilities<\/li>\n\n\n\n<li><strong>Market Positioning<\/strong>: Positions company for premium pricing in high-value COPD segment<\/li>\n\n\n\n<li><strong>International Expansion<\/strong>: Strong Phase II data supports potential global partnership opportunities<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-china-market-dynamics\">China Market Dynamics<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Local Innovation Preference<\/strong>: NMPA BTD reflects support for domestically developed innovative medicines<\/li>\n\n\n\n<li><strong>Reimbursement Strategy<\/strong>: Breakthrough designation enhances National Reimbursement Drug List (NRDL) negotiation position<\/li>\n\n\n\n<li><strong>Physician Adoption<\/strong>: Novel mechanism likely to generate significant interest among pulmonologists<\/li>\n\n\n\n<li><strong>Commercial Infrastructure<\/strong>: Haisco&#8217;s established sales force can rapidly deploy product upon approval<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape-assessment\">Competitive Landscape Assessment<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-copd-pipeline-competition\">COPD Pipeline Competition<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Limited Novel Mechanisms<\/strong>: Few companies advancing truly novel COPD mechanisms beyond bronchodilation<\/li>\n\n\n\n<li><strong>Chinese Innovation<\/strong>: Represents growing trend of Chinese pharmaceutical innovation in chronic diseases<\/li>\n\n\n\n<li><strong>Global Benchmarks<\/strong>: Performance will be compared against international COPD standards<\/li>\n\n\n\n<li><strong>Patent Protection<\/strong>: Strong intellectual property position critical for commercial success<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-development-risk-mitigation\">Development Risk Mitigation<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase II Success<\/strong>: Two successful studies significantly de-risk Phase III development<\/li>\n\n\n\n<li><strong>Regulatory Support<\/strong>: BTD provides additional safety net through enhanced regulatory guidance<\/li>\n\n\n\n<li><strong>Manufacturing Readiness<\/strong>: Inhalation powder formulation requires specialized manufacturing capabilities<\/li>\n\n\n\n<li><strong>Clinical Trial Design<\/strong>: Phase III protocols can leverage learnings from successful Phase II studies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-forward-development-pathway\">Forward Development Pathway<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase III Initiation<\/strong>: Expected to begin within 6-12 months with accelerated enrollment<\/li>\n\n\n\n<li><strong>Trial Design<\/strong>: Likely multi-center, randomized, placebo-controlled studies with active comparators<\/li>\n\n\n\n<li><strong>Primary Endpoints<\/strong>: Lung function measures (FEV1) with secondary quality of life assessments<\/li>\n\n\n\n<li><strong>Regulatory Strategy<\/strong>: Parallel preparation for NDA submission with potential international filings<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory designations, clinical development, and commercial potential. Actual results may differ due to risks including Phase III trial outcomes, 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\/04\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK39004\u5438\u5165\u7c89\u96fe\u5242\u7eb3\u5165\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7a0b\u5e8f\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK39004\u5438\u5165\u7c89\u96fe\u5242\u7eb3\u5165\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7a0b\u5e8f\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-6a954c82-4b5c-42f5-b58d-99521d1c2d36\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK39004\u5438\u5165\u7c89\u96fe\u5242\u7eb3\u5165\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7a0b\u5e8f\u7684\u516c\u544a.pdf\">\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK39004\u5438\u5165\u7c89\u96fe\u5242\u7eb3\u5165\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7a0b\u5e8f\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK39004\u5438\u5165\u7c89\u96fe\u5242\u7eb3\u5165\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7a0b\u5e8f\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-6a954c82-4b5c-42f5-b58d-99521d1c2d36\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China&#8217;s National Medical Products Administration (NMPA)&#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_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}},"categories":[7,11],"tags":[34,139,929],"class_list":["post-62645","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-haisco-pharmaceutical","tag-she-002653"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Haisco Pharmaceutical Secures NMPA Breakthrough Therapy Designation for HSK39004 Inhalation Powder in COPD, Following Successful Phase II Lung Function Data - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China&#039;s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for HSK39004 inhalation powder for the treatment of chronic obstructive pulmonary disease (COPD). 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