{"id":19874,"date":"2024-12-26T14:14:15","date_gmt":"2024-12-26T06:14:15","guid":{"rendered":"https:\/\/flcube.com\/?p=19874"},"modified":"2024-12-26T14:14:18","modified_gmt":"2024-12-26T06:14:18","slug":"cde-indicates-priority-review-for-boehringer-ingelheims-zongertinib-and-peers","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=19874","title":{"rendered":"CDE Indicates Priority Review for Boehringer Ingelheim&#8217;s Zongertinib and Peers"},"content":{"rendered":"\n<p>The China\u2019s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim\u2019s (BI) zongertinib, Visirna Therapeutics\u2019 plozasiran, Chia Tai Tianqing\u2019s anlotinib, and HutchMed (China) Ltd\u2019s (<a href=\"https:\/\/www.google.com\/finance\/quote\/0013:HKG\">HKG: 0013<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/HCM:NASDAQ\">NASDAQ: HCM<\/a>) Orpathys (savolitinib), are on course to obtain priority review statuses.<\/p>\n\n\n\n<p><strong>Boehringer Ingelheim\u2019s Zongertinib for HER2-Mutated NSCLC<\/strong><br>BI\u2019s zongertinib, a small molecule HER2 inhibitor, is poised for priority review status for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) activating mutations who have previously received systemic therapy. This development highlights the potential for improved treatment options in the fight against lung cancer.<\/p>\n\n\n\n<p><strong>Visirna Therapeutics\u2019 Plozasiran for Familial Chylomicron Syndrome (FCS)<\/strong><br>Visirna Therapeutics\u2019 plozasiran, an APOC3-targeted siNRA therapy co-developed by US firm Arrowhead Pharmaceuticals, is seeking approval for use in reducing triglyceride levels in adult patients with familial chylomicron syndrome (FCS), thereby reducing the risk of acute pancreatitis. The therapy aims to provide a dietary control-based solution for managing this rare condition.<\/p>\n\n\n\n<p><strong>Chia Tai Tianqing\u2019s Anlotinib for Acinar Soft Tissue Sarcoma<\/strong><br>Chia Tai Tianqing\u2019s anlotinib, a multi-target kinase inhibitor with existing indications for various cancers, is expected to win approval for the treatment of advanced or unresectable acinar soft tissue sarcoma. This further expands the drug\u2019s potential applications in oncology.<\/p>\n\n\n\n<p><strong>HutchMed\u2019s Savolitinib for NSCLC with MET Exon 14 Skipping Alterations<\/strong><br>HutchMed\u2019s savolitinib, an oral mesenchymal-epithelial transformation factor (MET) inhibitor, was conditionally approved in China in June 2021 for the treatment of NSCLC with MET exon 14 skipping alterations that has progressed after chemotherapy or is unsuited to systemic therapy. The drug, co-developed by AstraZeneca, is now indicated, when combined with osimertinib, for the treatment of locally advanced or metastatic NSCLC with failed EGFR-TKI treatment and MET amplification.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The China\u2019s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German&#8230;<\/p>\n","protected":false},"author":1,"featured_media":19876,"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":[390,661,1105,285,1104,80,1607],"class_list":["post-19874","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-boehringer-ingelheim","tag-chia-tai-tianqing-pharmaceutical","tag-hkg-0013","tag-hutchmed","tag-nasdaq-hcm","tag-priority-reviews","tag-visirna-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CDE Indicates Priority Review for Boehringer Ingelheim&#039;s Zongertinib and Peers - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim\u2019s (BI) zongertinib, Visirna Therapeutics\u2019 plozasiran, Chia Tai Tianqing\u2019s anlotinib, and HutchMed (China) Ltd\u2019s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses.\" \/>\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=19874\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDE Indicates Priority Review for Boehringer Ingelheim&#039;s Zongertinib and Peers\" \/>\n<meta property=\"og:description\" content=\"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim\u2019s (BI) zongertinib, Visirna Therapeutics\u2019 plozasiran, Chia Tai Tianqing\u2019s anlotinib, and HutchMed (China) Ltd\u2019s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=19874\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-26T06:14:15+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-12-26T06:14:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/CDE-Indicates-Priority-Review-for-Boehringer-Ingelheims-Zongertinib-and-Peers.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"673\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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