{"id":20200,"date":"2023-03-29T15:18:00","date_gmt":"2023-03-29T07:18:00","guid":{"rendered":"https:\/\/flcube.com\/?p=20200"},"modified":"2024-12-29T15:20:48","modified_gmt":"2024-12-29T07:20:48","slug":"keymed-biosciences-cm310-achieves-primary-endpoints-in-phase-iii-atopic-dermatitis-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20200","title":{"rendered":"Keymed Biosciences’ CM310 Achieves Primary Endpoints in Phase III Atopic Dermatitis Study"},"content":{"rendered":"\n

China-based Keymed Biosciences Inc., a prominent player in the biopharmaceutical industry (HKG: 2162<\/a>), has announced that its IL-4R\u03b1 monoclonal antibody (mAb) drug candidate, CM310, has successfully reached its primary endpoints in a confirmatory Phase III clinical study for the treatment of moderate to severe atopic dermatitis (AD).<\/p>\n\n\n\n

Phase III Study Design and Outcomes<\/strong>
The Phase III confirmatory study, a multi-center, randomized, double-blind, placebo-controlled trial, was designed to evaluate the efficacy, safety, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) effects, and immunogenicity of CM310 in patients with moderate to severe AD. Participants were randomly assigned to receive either CM310 (600mg-300mg Q2W) or a placebo. The primary endpoints included the rate of achieving an eczema area and severity index (EASI) – 75 (a decrease of at least 75% from baseline EASI score) at 16 weeks of treatment, and reaching an investigator’s global assessment (IGA) score of 0 or 1 with a decrease of at least 2 points from baseline. The study demonstrated that CM310 successfully met its main efficacy endpoints, exhibited good safety profiles, and was consistent with previous findings.<\/p>\n\n\n\n

Plans for Submission and Future Outlook<\/strong>
Following these positive results, Keymed Biosciences plans to engage in discussions with the National Medical Products Administration (NMPA) about the submission of the CM310 listing application for the treatment of adult moderate to severe atopic dermatitis in the near future. CM310 has previously shown promising safety and efficacy in multiple clinical trials, reinforcing the company’s commitment to advancing treatments for AD.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Keymed Biosciences Inc., a prominent player in the biopharmaceutical industry (HKG: 2162), has announced…<\/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_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[65,17,974,179],"class_list":["post-20200","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-clinical-trial-results","tag-hkg-2162","tag-keymed-biosciences"],"yoast_head":"\nKeymed Biosciences' CM310 Achieves Primary Endpoints in Phase III Atopic Dermatitis Study - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Keymed Biosciences Inc., a prominent player in the biopharmaceutical industry (HKG: 2162), has announced that its IL-4R\u03b1 monoclonal antibody (mAb) drug candidate, CM310, has successfully reached its primary endpoints in a confirmatory Phase III clinical study for the treatment of moderate to severe atopic dermatitis (AD).\" \/>\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=20200\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Keymed Biosciences' CM310 Achieves Primary Endpoints in Phase III Atopic Dermatitis Study\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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