{"id":25740,"date":"2022-09-15T21:00:00","date_gmt":"2022-09-15T13:00:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25740"},"modified":"2025-02-06T21:08:12","modified_gmt":"2025-02-06T13:08:12","slug":"cde-prioritizes-review-of-pearl-bios-breatinib-for-nsclc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25740","title":{"rendered":"CDE Prioritizes Review of Pearl Bio’s Breatinib for NSCLC Treatment"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101\/PLB1001 (breatinib), a small molecule kinase inhibitor targeting c-MET, is set for priority review for its use in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping. This development highlights the potential of breathinib as a new treatment option for patients with this specific type of lung cancer.<\/p>\n\n\n\n

Drug Background and Clinical Data<\/strong>
Breatinib, a highly selective c-Met inhibitor originated by Crown Bioscience, is now being co-developed by Crown Bioscience’s spin-off CBT Pharmaceuticals (now named Apollomics Inc.) and Pearl Bio. A Phase I clinical study has shown that the drug is well-tolerated and preliminarily able to penetrate the blood-brain barrier in patients, suggesting its potential efficacy in treating brain metastases.<\/p>\n\n\n\n

Market Landscape and Competitors<\/strong>
HutchMed’s Orpathys (savolitinib) was China’s first MET inhibitor to be approved, receiving regulatory approval in June last year for treating NSCLC with MET exon 14 skipping alterations following chemotherapy. Multiple c-Met inhibitors are under development in China, including HaiHe Bio’s glumetinib, Betta Pharma’s MCLA-129, a licensed bispecific antibody targeting EGFR and c-MET, Hansoh Pharma’s HS-10241, Hengrui Medicine’s SHR-A1403, a c-MET antibody drug conjugate (ADC), and Henlius’s HLX55. Glumetinib was awarded priority review status in February this year in China, where Merck’s tepotinib is awaiting regulatory decisions after a market filing in March.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101\/PLB1001…<\/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":[231,16,3573,1910,2586,270,1930,80],"class_list":["post-25740","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-betta-pharmaceuticals","tag-cancer","tag-crown-bioscience","tag-haihe-biopharma","tag-hengrui-pharmaceuticals","tag-henlius-biotech","tag-pearl-biotechnology","tag-priority-reviews"],"yoast_head":"\nCDE Prioritizes Review of Pearl Bio's Breatinib for NSCLC Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd's APL-101\/PLB1001 (breatinib), a small molecule kinase inhibitor targeting c-MET, is set for priority review for its use in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping. 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