{"id":30052,"date":"2025-03-20T23:47:52","date_gmt":"2025-03-20T15:47:52","guid":{"rendered":"https:\/\/flcube.com\/?p=30052"},"modified":"2025-03-20T23:47:56","modified_gmt":"2025-03-20T15:47:56","slug":"fosuns-henlius-receives-fda-orphan-drug-designation-for-her2-targeting-hlx22","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30052","title":{"rendered":"Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22"},"content":{"rendered":"\n

On March 19, 2025, Fosun Pharmaceutical (SHA: 600196<\/a>) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). This designation marks a significant milestone in the development of HLX22, positioning it for further clinical advancement.<\/p>\n\n\n\n

HLX22 Development and Clinical Trials<\/strong>
HLX22, a novel monoclonal antibody targeting HER2, was licensed from AbClon, Inc., and subsequently independently developed by Henlius. It is designed for the treatment of solid tumors, including gastric and breast cancer. The Phase I clinical trial of HLX22 as a monotherapy for HER2-overexpressing advanced solid tumors has been completed in mainland China (excluding Hong Kong, Macau, and Taiwan).<\/p>\n\n\n\n

The international multicenter Phase III clinical trial of HLX22 in combination with standard therapy (i.e., trastuzumab plus chemotherapy) for first-line treatment of locally advanced or metastatic gastroesophageal junction cancer and gastric cancer is ongoing in mainland China. This trial application has been approved in the U.S., Japan, and Australia.<\/p>\n\n\n\n

Additionally, the Phase II clinical trial of HLX22 in combination with standard therapy for first-line treatment of HER2-positive locally advanced\/metastatic gastric cancer is underway in mainland China. The National Medical Products Administration (NMPA) has also approved the Phase II clinical trial applications for HLX22 in combination with serplulimab injection and standard therapy for first-line treatment of locally advanced\/metastatic gastric cancer, as well as for HLX22 in combination with standard therapy or trastuzumab deruxtecan for the treatment of HER2-expressing solid tumors.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received…<\/p>\n","protected":false},"author":1,"featured_media":30053,"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":[16,159,270,83,892],"class_list":["post-30052","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-fosun-pharmaceutical","tag-henlius-biotech","tag-her2","tag-sha-600196"],"yoast_head":"\nFosun's Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22 - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). 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