{"id":23371,"date":"2022-12-26T01:21:00","date_gmt":"2022-12-25T17:21:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23371"},"modified":"2025-01-27T01:24:04","modified_gmt":"2025-01-26T17:24:04","slug":"cspcs-nbl-020-receives-fda-ind-approval-for-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23371","title":{"rendered":"CSPC’s NBL-020 Receives FDA IND Approval for Advanced Solid Tumors"},"content":{"rendered":"\n

China-based CSPC Pharmaceutical Group Ltd (HKG: 1093<\/a>) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. The targeted indication is advanced solid tumors, marking a significant step forward in the development of this innovative therapy.<\/p>\n\n\n\n

Drug Profile and Mechanism of Action<\/strong>
NBL-020 is an anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody (mAb) based on CSPC’s proprietary AFIS technology platform. TNFR2, a member of the tumor necrosis factor receptor (TNFR) superfamily, maintains the microenvironment of tumor cell immunosuppression through various signal pathways and directly or indirectly promotes tumor progression. It stimulates various immunosuppressive cell types, including regulatory T cells (Tregs) and bone marrow-derived suppressor cells (MDSCs), and can be used as an oncogene.<\/p>\n\n\n\n

Preclinical Data and Future Prospects<\/strong>
Pre-clinical studies have shown that NBL-020 exhibits good safety, high affinity to target cells, and strong anti-tumor activity. In PD-1 sensitive and PD-1 resistant syngeneic animal models, NBL-020 as a monotherapy or combined with an anti-PD-1 antibody can inhibit tumor growth and prolong survival. This promising data positions NBL-020 as a potential new treatment option for patients with advanced solid tumors.<\/p>\n\n\n\n

Global Landscape and Competitive Environment<\/strong>
BioInvent\u2019s BI-1808, the world\u2019s first TNFR2 inhibitor to receive clinical trial approval, is entering Phase IIa clinical study. In China, Leads Biolabs\u2019s LBL-019 is under trial review. Additionally, Begene\u2019s in-licensed TNFR2 antibody BITR2101 is expected to be used in combination with tislelizumab. Adlai Nortye and Sincere\u2019s TNFR2 mAbs are at the pre-clinical stages. The IND approval for NBL-020 underscores CSPC’s commitment to advancing innovative oncology therapies and contributing to the global effort to combat cancer.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval…<\/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":[16,62,171,855,107,18],"class_list":["post-23371","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-cspc-pharmaceutical","tag-hkg-1093","tag-immunotherapy","tag-pd-1-l1"],"yoast_head":"\nCSPC's NBL-020 Receives FDA IND Approval for Advanced Solid Tumors - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. 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