On January 5, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported 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 for the treatment of advanced solid tumors.
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In December 2025, 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, Europe and all other markets outside of Greater China. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. 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 in the near future.
About SKB105 (also known as CR-003)
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 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.
About SKB118(also known as CR-001)
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.
(Press release, Kelun, JAN 5, 2026, View Source [SID1234661730])