Kelun-Biotech’s novel ADC drug SKB518 has been granted the clearance of IND from the United States Food and Drug Administration (FDA)

CHENGDU, China, April 21, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company has been granted the clearance of investigational new drug (IND) application to initiated the clinical study of its potential first-in-class innovative ADC drug SKB518 from the United States Food and Drug Administration (FDA). 

In June 2024, the Company received a clinical trial notice approving the IND application for SKB518 for advanced solid tumors from Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Phase 1 clinical trial for SKB518 is ongoing in China.

About SKB518

SKB518 is a novel ADC drug with potential first-in-class target and proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the “OptiDC^TM” platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.

About Kelun-Biotech

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. The company 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 and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.