{"id":42887,"date":"2026-01-05T19:00:00","date_gmt":"2026-01-05T12:00:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=42887"},"modified":"2026-01-05T19:00:00","modified_gmt":"2026-01-05T12:00:00","slug":"kelun-biotech-receives-investigational-new-drug-approval-for-itgb6-targeted-adc-skb105-from-the-nmpa","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=42887","title":{"rendered":"Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC SKB105 from the NMPA"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

CHENGDU, China<\/span><\/span>, Jan. 5, 2026<\/span><\/span> \/PRNewswire\/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company”, 6990.HK) announced that its Investigational New Drug (IND) application for SKB105 (also known as CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China<\/span> for the treatment of advanced solid tumors.<\/p>\n

\n<\/div>\n

In December 2025<\/span>, Kelun-Biotech and Crescent Biopharma, Inc. (“Crescent”) entered into a strategic collaboration for SKB105\/CR-003 and SKB118 (a PD-1 x VEGF bispecific antibody, also known as CR-001). Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105\/CR-003 in the United States<\/span>, Europe<\/span> and all other markets outside of Greater China<\/span>. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118\/CR-001 in Greater China<\/span>. The IND application for SKB118\/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I\/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. Kelun-Biotech plans to submit an IND application for SKB118\/CR-001 to the Center for Drug Evaluation of the National Medical Products Administration of China<\/span> in the near future.<\/p>\n

About SKB105 (also known as CR-003)<\/u><\/b><\/p>\n

SKB105 is a differentiated ADC targeting ITGB6 with a topoisomerase I inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 incorporates proprietary Kthiol\u00ae<\/sup> irreversible conjugation technology, linking an anti-ITGB6 fully human Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) to a clinically validated cleavable linker. This design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.<\/p>\n

About SKB118(also known as CR-001)<\/u><\/b><\/p>\n

SKB118\/CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, SKB118\/CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118\/CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, particularly in conjunction with ADCs.\u00a0<\/p>\n

About Kelun-Biotech<\/u><\/b><\/p>\n

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China<\/span> and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC\u2122, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https:\/\/en.kelun-biotech.com\/<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

CHENGDU, China<\/span><\/span>, Jan. 5, 2026<\/span><\/span> \/PRNewswire\/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company”, 6990.HK) announced that its Investigational New Drug (IND) application for SKB105 (also known as CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China<\/span> for the treatment of advanced solid tumors.<\/p>\n

\n<\/div>\n

In December 2025<\/span>, Kelun-Biotech and Crescent Biopharma, Inc. (“Crescent”) entered into a strategic collaboration for SKB105\/CR-003 and SKB118 (a PD-1 x VEGF bispecific antibody, also known as CR-001). Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105\/CR-003 in the United States<\/span>, Europe<\/span> and all other markets outside of Greater China<\/span>. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118\/CR-001 in Greater China<\/span>. The IND application for SKB118\/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I\/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. Kelun-Biotech plans to submit an IND application for SKB118\/CR-001 to the Center for Drug Evaluation of the National Medical Products Administration of China<\/span> in the near future.<\/p>\n

About SKB105 (also known as CR-003)<\/u><\/b><\/p>\n

SKB105 is a differentiated ADC targeting ITGB6 with a topoisomerase I inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 incorporates proprietary Kthiol\u00ae<\/sup> irreversible conjugation technology, linking an anti-ITGB6 fully human Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) to a clinically validated cleavable linker. This design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.<\/p>\n

About SKB118(also known as CR-001)<\/u><\/b><\/p>\n

SKB118\/CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, SKB118\/CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118\/CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, particularly in conjunction with ADCs.\u00a0<\/p>\n

About Kelun-Biotech<\/u><\/b><\/p>\n

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China<\/span> and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC\u2122, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https:\/\/en.kelun-biotech.com\/<\/a>.<\/p>\n

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