{"id":26517,"date":"2022-08-23T21:59:00","date_gmt":"2022-08-23T13:59:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26517"},"modified":"2025-02-12T22:01:48","modified_gmt":"2025-02-12T14:01:48","slug":"anhui-ankes-hk010-bispecific-antibody-receives-nmpa-review-for-cancer-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26517","title":{"rendered":"Anhui Anke&#8217;s HK010 Bispecific Antibody Receives NMPA Review for Cancer Trials"},"content":{"rendered":"\n<p>Anhui Anke Biotechnology (Group) Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/300009:SHE\">SHE: 300009<\/a>) announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for HK010, a bispecific antibody (BsAb) targeting PD-L1 and 4-1BB, for the treatment of advanced malignant tumors.<\/p>\n\n\n\n<p><strong>Drug Profile<\/strong><br>HK010 is designed to block the PD-L1\/PD-1 pathway while conditionally activating the 4-1BB co-stimulatory signal, aiming to release immunosuppression and activate the immune system. The BsAb features a differential affinity design between the two antigen-binding ends and weakened Fc function to balance efficacy and toxicity. Preclinical studies in animal tumor models demonstrated potent anti-tumor activity, with a favorable safety profile in monkey toxicology studies.<\/p>\n\n\n\n<p><strong>Market Context<\/strong><br>China has multiple PD-L1\/4-1BB bispecific antibodies in development, including Biotheus Bio&#8217;s PM1003, Elpiscience Bio&#8217;s ES101, Qilu Pharma&#8217;s QLF31907, Leads Biolabs&#8217; LBL-024, I-Mab&#8217;s TJ-L14B\/ABL503, and Antengene&#8217;s ATG-101, all of which are in clinical stages.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that the National Medical Products Administration&#8230;<\/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":[482,62,28,18,997],"class_list":["post-26517","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-anke-biotechnology","tag-clinical-trial-approval-initiation","tag-multi-specific-antibodies","tag-pd-1-l1","tag-she-300009"],"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>Anhui Anke&#039;s HK010 Bispecific Antibody Receives NMPA Review for Cancer Trials - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for HK010, a bispecific antibody (BsAb) targeting PD-L1 and 4-1BB, for the treatment of advanced malignant tumors.\" \/>\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=26517\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anhui Anke&#039;s HK010 Bispecific Antibody Receives NMPA Review for Cancer Trials\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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