{"id":77761,"date":"2026-09-01T12:35:18","date_gmt":"2026-09-01T04:35:18","guid":{"rendered":"https:\/\/flcube.com\/?p=77761"},"modified":"2026-09-01T12:35:19","modified_gmt":"2026-09-01T04:35:19","slug":"shanghai-raass-sr604-enters-nmpa-cde-rare-disease-encouragement-program-for-hemophilia-and-factor-vii-deficiency-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=77761","title":{"rendered":"Shanghai RAAS&#8217;s SR604 Enters NMPA CDE Rare Disease Encouragement Program for Hemophilia and Factor VII Deficiency Treatment"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>China&#8217;s Shanghai RAAS (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/002252:SHE\">SHE: 002252<\/a>)<\/strong> announced that its candidate <strong>SR604<\/strong> has been included by the <strong>Center for Drug Evaluation (CDE)<\/strong> of the <strong>National Medical Products Administration (NMPA)<\/strong> into the <strong>Encouragement Pilot Program for Innovative Rare Disease Drug R&amp;D<\/strong> (&#8220;<strong>Caring Program &#8211; Extension<\/strong>&#8220;). The designation recognizes <strong>SR604 Injection<\/strong>, a novel humanized monoclonal antibody intended for the <strong>prophylactic treatment of bleeding<\/strong> in patients with <strong>hemophilia<\/strong> and <strong>congenital factor VII deficiency<\/strong>, as a priority innovation in China&#8217;s rare disease landscape.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory 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>Agency<\/td><td><strong>Center for Drug Evaluation (CDE)<\/strong> of the <strong>National Medical Products Administration (NMPA)<\/strong><\/td><\/tr><tr><td>Designation<\/td><td><strong>Encouragement Pilot Program for Innovative Rare Disease Drug R&amp;D<\/strong> (&#8220;Caring Program &#8211; Extension&#8221;)<\/td><\/tr><tr><td>Product<\/td><td><strong>SR604 Injection<\/strong> (humanized monoclonal antibody)<\/td><\/tr><tr><td>Indication<\/td><td>Prophylactic treatment of bleeding in <strong>hemophilia<\/strong> and <strong>congenital factor VII deficiency<\/strong><\/td><\/tr><tr><td>Sponsor<\/td><td><strong>Shanghai RAAS (SHE: 002252)<\/strong><\/td><\/tr><tr><td>Date<\/td><td><strong>28 Aug 2026<\/strong><\/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>Molecule:<\/strong> <strong>SR604 Injection<\/strong>, a <strong>humanized monoclonal antibody<\/strong> independently developed by <strong>Shanghai RAAS<\/strong><\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> High-affinity binding to <strong>human activated protein C (aPC)<\/strong>, specifically inhibiting the anticoagulant function of aPC \u2014 a novel rebalancing approach that shifts the hemostatic balance toward clot stability in bleeding disorders<\/li>\n\n\n\n<li><strong>Indications:<\/strong> Prophylactic treatment of bleeding in patients with <strong>hemophilia<\/strong> (including populations with and without inhibitors, per the aPC-inhibition concept) and <strong>congenital factor VII deficiency<\/strong><\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> The aPC-targeting mechanism offers a mechanism distinct from factor replacement and other rebalancing agents, with potential for broad applicability across hemophilia types<\/li>\n\n\n\n<li><strong>Rare Disease Priority:<\/strong> Inclusion in the &#8220;<strong>Caring Program &#8211; Extension<\/strong>&#8221; signals regulatory encouragement and potential pathway acceleration for innovative rare disease drugs in <strong>China<\/strong><\/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>Regulatory Tailwind:<\/strong> Entry into the <strong>NMPA CDE<\/strong> encouragement pilot program typically brings early regulatory communication and potential development acceleration, de-risking the clinical pathway for <strong>SR604<\/strong><\/li>\n\n\n\n<li><strong>Rare Disease Focus:<\/strong> <strong>Hemophilia<\/strong> and <strong>congenital factor VII deficiency<\/strong> represent high-unmet-need bleeding disorders in <strong>China<\/strong>, where access to prophylactic therapy remains limited relative to developed markets<\/li>\n\n\n\n<li><strong>Plasma Leader Diversifying:<\/strong> For <strong>Shanghai RAAS<\/strong> \u2014 a major player in blood products \u2014 <strong>SR604<\/strong> represents strategic expansion from plasma-derived therapies into innovative biologic development<\/li>\n\n\n\n<li><strong>Novel Mechanism Positioning:<\/strong> The aPC-inhibition approach places <strong>SR604<\/strong> within the global frontier of rebalancing hemophilia therapies, a space attracting significant industry and investor attention<\/li>\n\n\n\n<li><strong>Catalyst Watch:<\/strong> Clinical development milestones under the pilot program framework will be the key value drivers for <strong>Shanghai RAAS (SHE: 002252)<\/strong> as <strong>SR604<\/strong> advances<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2014 This brief contains forward-looking statements regarding regulatory designation, clinical development, and market potential that involve risks and uncertainties. Regulatory inclusion does not guarantee approval. Nothing herein constitutes investment advice.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s Shanghai RAAS (SHE: 002252) announced that its candidate SR604 has been included by the&#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":[7,4],"tags":[24,3106,1333],"class_list":["post-77761","post","type-post","status-publish","format-standard","hentry","category-company","category-policy-regulatory","tag-rare-orphan-disease-drugs","tag-shanghai-raas","tag-she-002252"],"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>Shanghai RAAS&#039;s SR604 Enters NMPA CDE Rare Disease Encouragement Program for Hemophilia and Factor VII Deficiency Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s Shanghai RAAS (SHE: 002252) announced that its candidate SR604 has been included by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) into the Encouragement Pilot Program for Innovative Rare Disease Drug R&amp;D (&quot;Caring Program - Extension&quot;). 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