{"id":38189,"date":"2025-07-30T12:45:23","date_gmt":"2025-07-30T04:45:23","guid":{"rendered":"https:\/\/flcube.com\/?p=38189"},"modified":"2025-07-30T12:45:24","modified_gmt":"2025-07-30T04:45:24","slug":"huadong-medicine-receives-nmpa-approval-for-phase-iii-trial-of-psoriasis-cream-mc2-01","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=38189","title":{"rendered":"Huadong Medicine Receives NMPA Approval for Phase III Trial of Psoriasis Cream MC2-01"},"content":{"rendered":"\n<p>China-based Huadong Medicine Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/000963:SHE\">SHE: 000963<\/a>) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct Phase III clinical trials for its psoriasis treatment, MC2-01 cream. This marks a significant step forward in the development of this innovative dermatological agent.<\/p>\n\n\n\n<p><strong>MC2-01 Cream Overview<\/strong><br>MC2-01 is a novel topical dermatological agent developed through a cooperation agreement between Huadong Medicine and MC2 Therapeutics Ltd., signed in August 2023. Huadong Medicine holds exclusive rights to the product in the Greater China region, including Mainland China, Hong Kong SAR, Macau SAR, and Taiwan.<\/p>\n\n\n\n<p><strong>Drug Mechanism and Formulation<\/strong><br>MC2-01 is a fixed-dose combination of calcipotriol and betamethasone, designed for the topical treatment of adult plaque psoriasis, including scalp psoriasis. The product utilizes MC2&#8217;s proprietary drug delivery system, PAD, and is formulated as a user-friendly aqueous cream.<\/p>\n\n\n\n<p><strong>International Recognition and Approvals<\/strong><br>MC2-01 received approval from the U.S. Food and Drug Administration (FDA) in 2020 and gained approval in Europe in 2021. It was launched in Australia in November 2024, underscoring its global potential and effectiveness in treating psoriasis.<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\/2025\/07\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a-2.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a (2).\"><\/object><a id=\"wp-block-file--media-780ab2b6-a144-4c81-880c-f82fabe12eec\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/07\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a-2.pdf\">\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a (2)<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/07\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a-2.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-780ab2b6-a144-4c81-880c-f82fabe12eec\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the&#8230;<\/p>\n","protected":false},"author":1,"featured_media":38192,"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":[62,114,2287,887],"class_list":["post-38189","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-huadong-medicine","tag-mc2-therapeutics","tag-she-000963"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Huadong Medicine Receives NMPA Approval for Phase III Trial of Psoriasis Cream MC2-01 - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct Phase III clinical trials for its psoriasis treatment, MC2-01 cream. This marks a significant step forward in the development of this innovative dermatological agent.\" \/>\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=38189\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Huadong Medicine Receives NMPA Approval for Phase III Trial of Psoriasis Cream MC2-01\" \/>\n<meta property=\"og:description\" content=\"China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct Phase III clinical trials for its psoriasis treatment, MC2-01 cream. 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