#China #Chengdu #Cancer Treatment #Kelun-Biotech #SKB105

Kelun-Biotech Receives New Drug Approval

On January 5, 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., commonly known as Kelun-Biotech, announced the approval of its Investigational New Drug (IND) application for SKB105, a cutting-edge antibody-drug conjugate (ADC) designed to target integrin beta-6 (ITGB6), from the National Medical Products Administration (NMPA) in China. This landmark decision positions the drug as a promising treatment option for advanced solid tumors, widening the horizons in cancer therapy.

Strategic Collaboration with Crescent Biopharma

In December 2025, Kelun-Biotech entered into a strategic partnership with Crescent Biopharma, Inc. This collaboration gives Crescent exclusive rights to research, develop, manufacture, and commercialize SKB105 in the United States, Europe, and other regions excluding Greater China. Conversely, Crescent offers Kelun-Biotech the exclusive rights for SKB118 (also referred to as CR-001) within Greater China. The IND for SKB118 has already received approval from the U.S. FDA, and clinical trials are slated to commence soon for this promising treatment targeting solid tumors as well.

Understanding SKB105 (CR-003)

SKB105 is distinguished as an ADC that utilizes a topoisomerase I inhibitor payload targeting ITGB6. This specific integrin is known to be overexpressed in various solid tumors but shows minimal expression in most normal tissues, which lowers the chances of systemic toxicity and adverse side effects. The innovative design employs proprietary Kthiol® irreversible conjugation technology, linking a fully human immunoglobulin G1 (IgG1) monoclonal antibody to a clinically validated cleavable linker. This method enhances both stability and tumor-specific delivery of the treatment, aiming to maximize efficacy while minimizing harmful effects. Preclinical tests have indicated that SKB105 showcases a highly favorable efficacy, safety, and pharmacokinetic profile.

Delving into SKB118 (CR-001)

In addition to SKB105, the partnership with Crescent also promotes the development of SKB118 (CR-001), a tetravalent bispecific antibody aimed at treating solid tumors by combining mechanisms that inhibit PD-1 and VEGF. The blockade of PD-1 is designed to restore T cell function allowing them to identify and eliminate tumor cells, while the inhibition of VEGF aims to decrease the blood supply to tumors, effectively inhibiting their growth. Preclinical studies have illustrated that SKB118/CR-001 could enhance anti-tumor activity significantly, with the potential to normalize vascular structures at the tumor site, thereby improving the effectiveness of combination therapies including ADCs.

About Kelun-Biotech

Kelun-Biotech serves as a subsidiary of Kelun Pharmaceutical, specializing in research, development, manufacturing, and the commercialization of innovative drugs ranging from biological to small molecule pharmaceuticals. The company focuses on critical disease areas, prominently solid tumors, autoimmune disorders, and metabolic diseases. With ambitions to lead in the innovative drug sector globally, Kelun-Biotech currently has over 30 pivotal projects, with four having received marketing approvals, and numerous others at various stages of clinical trials. The firm has distinguished itself by establishing a leading proprietary ADC and novel drug delivery platform known as OptiDC™, supporting its many ongoing projects in both clinical and preclinical phases.

For more updates, please visit Kelun-Biotech's official site.