{"id":16840,"date":"2024-12-05T14:30:48","date_gmt":"2024-12-05T06:30:48","guid":{"rendered":"https:\/\/flcube.com\/?p=16840"},"modified":"2024-12-05T14:30:52","modified_gmt":"2024-12-05T06:30:52","slug":"shanghai-henlius-biotechs-hlx22-receives-nmpa-approval-for-phase-ii-her2-targeted-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=16840","title":{"rendered":"Shanghai Henlius Biotech&#8217;s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study"},"content":{"rendered":"\n<p>Shanghai Henlius Biotech Inc., (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase II study, exploring its efficacy when combined with trastuzumab plus chemotherapy or combined with trastuzumab deruxtecan in HER2-expressing solid tumors.<\/p>\n\n\n\n<p><strong>HLX22 Development for Gastric and Breast Cancer<\/strong><br>HLX22 is under development to treat gastric cancer, breast cancer, and other solid tumors. It has previously completed a Phase I study in advanced solid tumors in China. The upcoming Phase II study will build upon these initial findings, investigating the potential synergistic effects of HLX22 in combination with other HER2-targeted therapies.<\/p>\n\n\n\n<p><strong>Preclinical Research and Synergy with Trastuzumab<\/strong><br>Preclinical research results have indicated that the combination of HLX22 and trastuzumab, another HER2-targeted mAb, produces a synergistic effect, leading to better tumor suppression compared to the use of either drug as a monotherapy. This suggests that the combination therapy may offer enhanced efficacy in treating HER2-expressing tumors.<\/p>\n\n\n\n<p><strong>Combination with Trastuzumab Deruxtecan and Safety Profile<\/strong><br>Additionally, preclinical animal trials of HLX22 combined with trastuzumab deruxtecan, an HER2-targeted antibody drug conjugate (ADC) approved in the US, China, Europe, and other regions, have shown synergistic anti-tumor effects and a good safety profile. This combination therapy strategy holds promise for improving treatment outcomes in patients with HER2-expressing solid tumors.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced&#8230;<\/p>\n","protected":false},"author":1,"featured_media":16862,"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":[35,16,62,29,270,83,862],"class_list":["post-16840","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-approval-initiation","tag-combination-therapy","tag-henlius-biotech","tag-her2","tag-hkg-2696"],"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>Shanghai Henlius Biotech&#039;s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. 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