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Sichuan Kelun-Biotech Biopharmaceutical Co Ltd, a holding subsidiary of Kelun Pharmaceutical which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, 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.
As one of the industry leaders in the antibody-drug conjugate field, Kelun-Biotech has established a solid competitive advantage. Currently, the company's self-developed TROP2 antibody-drug conjugate and HER2 antibody-drug conjugate have been approved for marketing, demonstrating significant clinical efficacy and competitive differentiation. Focusing on advances in oncology therapeutics, Kelun-Biotech continues to expand its innovative layout by building a diversified pipeline covering cutting-edge therapies such as RDCs and bsADCs and fully driving breakthroughs and innovations in existing cancer treatment paradigms.
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 realize 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 Dr. Michael Ge, CEO of Kelun-Biotech. "Innovation in IO and antibody-drug conjugate is currently reshaping the global cancer treatment landscape. Leveraging our systematic and platform-based R&D capabilities and extensive antibody-drug conjugate development experience, we will advance the development of next-generation antibody-drug conjugate 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."
Kelun-Biotech focuses on major disease areas such as solid tumours, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, one project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary antibody-drug conjugate and novel DC platforms, OptiDC, and has two antibody-drug conjugate projects with 5 indications approved for marketing, and multiple antibody-drug conjugate and novel DC assets in clinical or preclinical research stage.
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