{"id":14002,"date":"2024-11-21T18:19:42","date_gmt":"2024-11-21T10:19:42","guid":{"rendered":"https:\/\/flcube.com\/?p=14002"},"modified":"2024-11-21T18:19:45","modified_gmt":"2024-11-21T10:19:45","slug":"sino-biopharmaceutical-submits-nda-for-anlotinib-and-penpulimab-combo-in-hcc-to-nmpa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14002","title":{"rendered":"Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA"},"content":{"rendered":"\n<p>China-based Sino Biopharmaceutical Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/1177:HKG\">HKG: 1177<\/a>) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC).<\/p>\n\n\n\n<p><strong>Phase III Study Data Supports NDA Filing<\/strong><br>The filing is supported by data from the Phase III ALTN-AK105-III-02 study, which successfully reached its pre-set endpoints in August 2024. The study demonstrated that the combination therapy achieved a median progression-free survival (PFS) of 6.9 months, compared to 2.8 months in the control group, significantly reducing the risk of disease progression or death by 47%. Additionally, the median overall survival (OS) in the experimental group was 16.5 months, versus 13.2 months in the control group, significantly reducing the risk of death by 31%.<\/p>\n\n\n\n<p><strong>Background on Anlotinib and Penpulimab<\/strong><br>Anlotinib, a multi-target tyrosine kinase inhibitor (TKI), was licensed to Sino Bio by Advenchen Laboratories and obtained marketing approval in China in May 2018 for the treatment of previously treated advanced non-small cell lung cancer (NSCLC). Penpulimab, a PD-1 inhibitor co-developed by Sino Bio and Akeso Biopharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/9926:HKG\">HKG: 9926<\/a>), was approved in China in August 2021 as a third-line treatment for relapsed\/refractory classic Hodgkin lymphoma (cHL). The approval of this new indication would mark the 10th for anlotinib and the 5th for penpulimab in China.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application&#8230;<\/p>\n","protected":false},"author":1,"featured_media":14003,"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":[360,16,29,908,850,38,18,313,33],"class_list":["post-14002","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-akeso-biopharma","tag-cancer","tag-combination-therapy","tag-hkg-1177","tag-hkg-9926","tag-market-approval-filings","tag-pd-1-l1","tag-sino-biopharmaceutical","tag-tkis-egfr-vegf-btk-etc"],"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>Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC).\" \/>\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=14002\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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