{"id":259,"date":"2024-08-28T13:41:11","date_gmt":"2024-08-28T05:41:11","guid":{"rendered":"https:\/\/flcube.com\/?p=259"},"modified":"2024-10-13T18:05:00","modified_gmt":"2024-10-13T10:05:00","slug":"bio-thera-solutions-bat8006-receives-nmpa-approval-for-clinical-trial-in-recurrent-ovarian-cancer-maintenance-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=259","title":{"rendered":"Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy"},"content":{"rendered":"\n

Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177<\/a>), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer.<\/p>\n\n\n\n

BAT8006, an in-house developed ADC, targets the folate receptor alpha (FR\u03b1), a protein overexpressed on the cell membrane of various solid tumors, including ovarian, lung, and breast cancer. It is characterized by limited distribution and low expression in normal tissues, which makes it an attractive target for cancer therapies. The ADC is composed of a recombinant humanized anti-FR\u03b1 antibody conjugated with a potent small-molecule topoisomerase I inhibitor. Pre-clinical studies have demonstrated BAT8006’s good stability and safety, along with strong anti-tumor efficacy and the potential for best-in-class status.<\/p>\n\n\n\n

As a monotherapy, BAT8006 has completed dose escalation studies, with dose optimization studies now fully enrolled and in the follow-up phase. The company is also conducting cohort expansion studies under the RP2D dosage for multiple tumor types. In addition, a Phase Ib\/II study combining BAT8006 with BAT1308, a PD-1 inhibitor, is actively enrolling patients.- Flcube.com<\/a><\/p>\n\n\n\n

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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange…<\/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":[35,289,16,62,1055],"class_list":["post-259","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-bio-thera-solutions","tag-cancer","tag-clinical-trial-approval-initiation","tag-sha-688177"],"yoast_head":"\nBio-Thera Solutions' BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. 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