Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the Investigational New Drug (IND) application for SKB103, its self-developed novel bispecific antibody-drug conjugate with combined tumour-associated antigen-targeting and immuno-oncology mechanisms (TAA-PD-L1 bsADC), 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 tumours.
The approval marks SKB103 as the company’s first TAA-PD-L1 bsADC candidate and its second bsADC programme for tumour therapy to enter the clinical stage, following SKB571.
SKB103 is a potential best-in-class novel bsADC developed using Kelun-Biotech’s proprietary OptiDC platform. Designed as a single molecule, it is expected to realise targeted delivery of cytotoxic payloads to tumours and modulation of tumour immune microenvironment simultaneously. In preclinical studies, SKB103 demonstrated outstanding anti-tumour activity and a favourable safety profile. The therapeutic potential of SKB103 will support its subsequent clinical development.
“The IND approval for SKB103 represents another important milestone in our bsADCs pipeline and reflects the continued clinical translation of our novel DC strategy, further solidifying our core technical advantages in the ADC field,” said Michael Ge, CEO of Kelun-Biotech.
“Innovation in IO and ADC is currently reshaping the global cancer treatment landscape. Leveraging our systematic and platform-based R&D capabilities and extensive ADC development experience, we will advance the development of next-generation ADC drugs like SKB103, deeply explore the global clinical value of our portfolio, and fully promote innovation in cancer therapies, opening up broader prospects for the treatment of patients worldwide and the Company’s sustainable development.”