{"id":18346,"date":"2023-05-29T23:37:00","date_gmt":"2023-05-29T15:37:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18346"},"modified":"2024-12-16T23:45:54","modified_gmt":"2024-12-16T15:45:54","slug":"ascentage-pharmas-olverembatinib-earns-breakthrough-designation-for-sdh-deficient-gist","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18346","title":{"rendered":"Ascentage Pharma’s Olverembatinib Earns Breakthrough Designation for SDH-Deficient GIST"},"content":{"rendered":"\n

The China’s Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to olverembatinib, a Category 1 drug developed by Suzhou Ascentage Pharma Co., Ltd’s (HKG: 6855<\/a>) wholly-owned subsidiary, Guangzhou Shunjian Biopharmaceutical Technology Co., Ltd. The designation targets succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST) that have received first-line treatment.<\/p>\n\n\n\n

Olverembatinib: A Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)<\/strong>
Olverembatinib, an oral third-generation BCR-ABL TKI, was previously conditionally approved on November 25, 2021, for the treatment of chronic phase and accelerated phase chronic myeloid leukemia (CML CP\/AP) with T315I mutation, which is resistant to other TKI treatments. In July 2022, it obtained priority review status for the indication of chronic myeloid leukemia (CML) chronic phase (CP) patients who are resistant to or intolerant of first- and second-generation TKIs.<\/p>\n\n\n\n

Market Landscape for GIST Treatments in China<\/strong>
Currently, there are no domestically developed drugs in China for the treatment of GIST. However, the market does include imported drugs such as Pfizer\u2019s Sutent (Sunitinib), Novartis\u2019s Gleevec (Imatinib), and Bayer\u2019s Stivarga (Regorafenib). Additionally, CStone Pharma\u2019s Ayvakit (Avapritinib) and Zai Lab\u2019s Qinlock (Ripretinib) are in-licensed products available in the country, along with generic versions of Sunitinib and Imatinib.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

The China’s Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to olverembatinib,…<\/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":[200,269,34,16,188,985,140,309,2784,33,413],"class_list":["post-18346","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-ascentage-pharma","tag-bayer","tag-breakthrough-therapy","tag-cancer","tag-cstone-pharmaceuticals","tag-hkg-6855","tag-novartis","tag-pfizer","tag-shunjian-biopharmaceutical-technology","tag-tkis-egfr-vegf-btk-etc","tag-zai-lab"],"yoast_head":"\nAscentage Pharma's Olverembatinib Earns Breakthrough Designation for SDH-Deficient GIST - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China's Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to olverembatinib, a Category 1 drug developed by Suzhou Ascentage Pharma Co., Ltd's (HKG: 6855) wholly-owned subsidiary, Guangzhou Shunjian Biopharmaceutical Technology Co., Ltd. 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