{"id":30296,"date":"2025-03-25T10:56:20","date_gmt":"2025-03-25T02:56:20","guid":{"rendered":"https:\/\/flcube.com\/?p=30296"},"modified":"2025-03-25T10:56:21","modified_gmt":"2025-03-25T02:56:21","slug":"suzhou-xueji-biotechs-xj-mk-002-gets-fda-orphan-drug-designation-for-camt","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30296","title":{"rendered":"Suzhou Xueji Biotech&#8217;s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT"},"content":{"rendered":"\n<p>China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd\u2019s (HemaCell) XJ-MK-002, described as the world\u2019s first platelet-related cell therapy, received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) last week. The designation is for the treatment of congenital amegakaryocytic thrombocytopenia (CAMT), a rare hereditary bone marrow failure syndrome. Concurrently, a pre-IND application has been filed with the FDA for XJ-MK-001, HemaCell\u2019s first-in-class cell therapy to treat thrombocytopenia.<\/p>\n\n\n\n<p><strong>Therapy Differentiation and Advantages<\/strong><br>These therapies, which do not require gene editing, are differentiated from hematopoietic stem cells through simulated developmental processes. This approach is noted for being safe, reliable, and demonstrating significant therapeutic effects. The products feature stable production processes, short cycles, and low infusion doses, enabling sustained and efficient recovery of platelet counts.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd\u2019s (HemaCell) XJ-MK-002, described as the world\u2019s&#8230;<\/p>\n","protected":false},"author":1,"featured_media":30299,"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":[77,3891,24,3890],"class_list":["post-30296","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cell-therapy","tag-hemacell","tag-rare-orphan-disease-drugs","tag-xueji-biotechnology"],"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>Suzhou Xueji Biotech&#039;s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd\u2019s (HemaCell) XJ-MK-002, described as the world\u2019s first platelet-related cell therapy, received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) last week. The designation is for the treatment of congenital amegakaryocytic thrombocytopenia (CAMT), a rare hereditary bone marrow failure syndrome. Concurrently, a pre-IND application has been filed with the FDA for XJ-MK-001, HemaCell\u2019s first-in-class cell therapy to treat thrombocytopenia.\" \/>\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=30296\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Suzhou Xueji Biotech&#039;s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT\" \/>\n<meta property=\"og:description\" content=\"China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd\u2019s (HemaCell) XJ-MK-002, described as the world\u2019s first platelet-related cell therapy, received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) last week. 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