{"id":15999,"date":"2023-07-20T14:02:00","date_gmt":"2023-07-20T06:02:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15999"},"modified":"2024-12-01T14:23:47","modified_gmt":"2024-12-01T06:23:47","slug":"chipscreen-pharmaceuticals-epidaza-granted-priority-status-for-dlbcl-treatment-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15999","title":{"rendered":"Chipscreen Pharmaceutical’s Epidaza Granted Priority Status for DLBCL Treatment in China"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd\u2019s (SHA: 688321<\/a>) Epidaza (chidamide) has been granted priority status for the treatment of treatment-na\u00efve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin, vincristine, and prednisone). The new indication filing is supported by the results of a randomized, double-blind, placebo-controlled, multi-center Phase III study, which showed complete response rate (CRR) and event-free survival (EFS) outcomes that meet conditional approval criteria.<\/p>\n\n\n\n

Chipscreen\u2019s Chidamide: A First-In-Class Histone Deacetylase Inhibitor<\/strong>
Chipscreen\u2019s chidamide is a first-in-class subtype-selective histone deacetylase inhibitor that has been available in China since December 2014 for the treatment of the rare disease peripheral T-cell lymphoma. In November 2019, a second indication was approved for use in combination with hormonal therapy for previously treated ER+\/HER2- advanced breast cancer. The drug has also received approval in Japan for the treatment of adult T-cell leukemia (ATL) and peripheral T-cell lymphoma (PTCL).<\/p>\n\n\n\n

Licensing and Global Expansion<\/strong>
In 2013, Chipscreen licensed the rights to the molecule to GNT Biotech & Medicals Corporation in Taiwan, where it was approved in March this year for the treatment of postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor-positive and human epidermal growth factor receptor II (HER2) negative, and have relapsed or deteriorated after endocrine therapy combined with exemestane.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd\u2019s…<\/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":[16,1852,80,1240],"class_list":["post-15999","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-conditional-approvals","tag-priority-reviews","tag-sha-688321"],"yoast_head":"\nChipscreen Pharmaceutical's Epidaza Granted Priority Status for DLBCL Treatment in China - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd\u2019s (SHA: 688321) Epidaza (chidamide) has been granted priority status for the treatment of treatment-na\u00efve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin, vincristine, and prednisone). The new indication filing is supported by the results of a randomized, double-blind, placebo-controlled, multi-center Phase III study, which showed complete response rate (CRR) and event-free survival (EFS) outcomes that meet conditional approval criteria.\" \/>\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=15999\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Chipscreen Pharmaceutical's Epidaza Granted Priority Status for DLBCL Treatment in China\" \/>\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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