{"id":24967,"date":"2022-10-21T21:18:00","date_gmt":"2022-10-21T13:18:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24967"},"modified":"2025-02-02T21:21:40","modified_gmt":"2025-02-02T13:21:40","slug":"hengrui-medicine-files-for-dalpiciclib-as-initial-therapy-for-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24967","title":{"rendered":"Hengrui Medicine Files for Dalpiciclib as Initial Therapy for Breast Cancer"},"content":{"rendered":"\n

China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276<\/a>) has announced a supplementary market filing for its CDK 4\/6 inhibitor, dalpiciclib (SHR6390), as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer. The filing has been accepted for review by the National Medical Products Administration (NMPA).<\/p>\n\n\n\n

Clinical Study and Filing Basis<\/strong>
The filing is based on the results of the multi-center, randomized, placebo-controlled, double-blind Phase III DAWNA-2 study. The study demonstrated that dalpiciclib, when combined with an aromatase inhibitor as the initial treatment, significantly extended progression-free survival (PFS) in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer. These results highlight the potential of dalpiciclib to improve outcomes for patients with this challenging form of breast cancer.<\/p>\n\n\n\n

Dalpiciclib: First Domestic CDK 4\/6 Inhibitor<\/strong>
Dalpiciclib is China\u2019s first domestically-developed cyclin-dependent kinase 4 and 6 (CDK 4\/6) inhibitor. It obtained market approval in China in December 2021 with priority review status for use in HR-positive and HER2-negative recurrent or metastatic breast cancer that has progressed after endocrine therapy, combined with fulvestrant. Similar products currently marketed in China include Pfizer\u2019s Ibrance (palbociclib) and Eli Lilly\u2019s Verzenio (abemaciclib), the latter of which entered the National Reimbursement Drug List (NRDL) in December 2021.<\/p>\n\n\n\n

Future Outlook<\/strong>
The supplementary market filing for dalpiciclib underscores Hengrui Medicine’s commitment to expanding the therapeutic options available for patients with HR-positive, HER2-negative breast cancer. If approved, dalpiciclib could offer a new first-line treatment option, potentially improving patient outcomes and further solidifying Hengrui’s position in the oncology market.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for…<\/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":[16,2586,38,852],"class_list":["post-24967","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-hengrui-pharmaceuticals","tag-market-approval-filings","tag-sha-600276"],"yoast_head":"\nHengrui Medicine Files for Dalpiciclib as Initial Therapy for Breast Cancer - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for its CDK 4\/6 inhibitor, dalpiciclib (SHR6390), as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer. 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