{"id":26333,"date":"2022-08-30T17:40:00","date_gmt":"2022-08-30T09:40:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26333"},"modified":"2025-02-11T17:51:12","modified_gmt":"2025-02-11T09:51:12","slug":"hengrui-medicines-dalpiciclib-hits-superiority-criteria-in-phase-iii-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26333","title":{"rendered":"Hengrui Medicine’s Dalpiciclib Hits Superiority Criteria in Phase III Study"},"content":{"rendered":"\n

China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276<\/a>) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4\/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast cancer.<\/p>\n\n\n\n

Study Details<\/strong>
The multi-center, randomized, double-blind trial enrolled 456 patients at a 2:1 ratio. Primary endpoint: investigator-evaluated PFS. Secondary endpoints included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and safety. Results showed dalpiciclib plus an aromatase inhibitor as initial therapy significantly extended PFS.<\/p>\n\n\n\n

Drug Profile<\/strong>
Dalpiciclib, China’s first homegrown CDK 4\/6 inhibitor, received market approval in December 2021 for HR-positive, HER2-negative recurrent\/metastatic breast cancer post-endocrine therapy, combined with fulvestrant.<\/p>\n\n\n\n

Market Context<\/strong>
Global sales of similar CDK 4\/6 inhibitors\u2014Pfizer’s Ibrance (palbociclib), Eli Lilly’s Verzenio (abemaciclib), G1 Therapeutics’ trilaciclib, and Novartis’s ribociclib\u2014reached USD 7.735 billion in 2021.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study…<\/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":[16,17,29,2586,109,852],"class_list":["post-26333","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-results","tag-combination-therapy","tag-hengrui-pharmaceuticals","tag-precision-medicine","tag-sha-600276"],"yoast_head":"\nHengrui Medicine's Dalpiciclib Hits Superiority Criteria in Phase III Study - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4\/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast cancer.\" \/>\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=26333\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Medicine's Dalpiciclib Hits Superiority Criteria in Phase III Study\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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