The 6990.HK drugmaker said the NMPA's CDE cleared advanced solid tumor studies, marking its first dual-payload ADC to enter the clinical stage and extending its broader "ADC + IO" strategy.
Kelun-Biotech said it received an Investigational New Drug clearance from the Center for Drug Evaluation of the National Medical Products Administration, allowing clinical testing of SKB565 in advanced solid tumors in China. The candidate is the company's first dual-payload ADC (antibody-drug conjugate, targeted cancer therapy) to enter the clinical stage. The company said SKB565 was developed on its proprietary OptiDC platform and is designed to deliver both toxins and immunomodulators to tumor tissue. That approach is intended to combine direct tumor killing with immune activation in the tumor microenvironment, a strategy Kelun-Biotech said could produce stronger and more durable antitumor activity than conventional ADCs that carry only toxins. It added that preclinical studies showed antitumor activity and safety supportive of further development. Kelun-Biotech framed SKB565 as part of its broader "ADC + IO" strategy, which includes combination studies pairing ADCs with PD-(L)1 monoclonal antibodies and the PD-1/VEGF bispecific antibody SKB118, alongside efforts to build synergistic functions into single ADC molecules. CEO Dr. Michael Ge said the program is a core example of that strategy and that the company will actively advance clinical development of novel drug conjugates such as SKB565. Kelun-Biotech, a holding subsidiary of Kelun Pharmaceutical, said it has more than 30 ongoing key innovative drug projects, with 4 projects covering 8 indications approved for marketing, 1 project in the NDA (new drug application) stage and more than 10 in the clinical stage. It also said it has 2 ADC projects with 5 indications approved for marketing, plus multiple ADC and novel DC assets in clinical or preclinical research.