{"id":30845,"date":"2025-03-28T15:45:54","date_gmt":"2025-03-28T07:45:54","guid":{"rendered":"https:\/\/flcube.com\/?p=30845"},"modified":"2025-03-28T15:45:56","modified_gmt":"2025-03-28T07:45:56","slug":"huadong-medicine-gains-nmpa-approval-for-hdm3019-rheumatoid-arthritis-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30845","title":{"rendered":"Huadong Medicine Gains NMPA Approval for HDM3019 Rheumatoid Arthritis Trial"},"content":{"rendered":"\n

China-based Huadong Medicine Co., Ltd (SHE: 000963<\/a>) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its HDM3019 in rheumatoid arthritis (RA). This marks a significant step forward for the company in expanding its portfolio in autoimmune diseases.<\/p>\n\n\n\n

Drug Profile and Preclinical Results<\/strong>
HDM3019 is a bispecific antibody (BsAb) targeting OX40L and TNF\u03b1. In pre-clinical pharmacodynamic studies, it demonstrated improved clinical scores of arthritis, alleviated joint swelling, and reduced joint damage compared to the negative control group. These results indicate that HDM3019 has robust inflammation control effects and may be more effective than current mainstream TNF alpha antagonists.<\/p>\n\n\n\n

Strategic Licensing Deal<\/strong>
In August 2024, Huadong Medicine secured a licensing deal with South Korea-based IMBiologics Corp., obtaining exclusive development, regulatory filing, manufacturing, and commercialization rights to HDM3019 and another autoimmune drug in 37 Asian countries (including China but excluding Japan, South Korea, and North Korea).<\/p>\n\n\n\n

Clinical Progress<\/strong>
HDM3019 has completed Phase Ia study in the US, showing good safety and tolerability in healthy subjects with a single-dose regimen. This paves the way for further clinical development and potential commercialization.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Huadong Medicine Co., Ltd (SHE: 000963) announced receiving approval from the National Medical Products…<\/p>\n","protected":false},"author":1,"featured_media":30846,"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":[62,114,887],"class_list":["post-30845","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-huadong-medicine","tag-she-000963"],"yoast_head":"\nHuadong Medicine Gains NMPA Approval for HDM3019 Rheumatoid Arthritis Trial - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Huadong Medicine Co., Ltd (SHE: 000963) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its HDM3019 in rheumatoid arthritis (RA). 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