 |
CHENGDU, China, March 24, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) today announced that the Investigational New Drug (IND) application for SKB103, its self-developed novel bispecific antibody-drug conjugate with combined Tumor-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 tumors. The approval marks SKB103 as the Company's first TAA-PD-L1 bsADC candidate and its second bsADC program for tumor therapy to enter the clinical stage, following SKB571.
As one of the industry leaders in the ADC field, Kelun-Biotech has established a solid competitive advantage. Currently, the Company's self-developed TROP2 ADC and HER2 ADC 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 tumors and modulation of tumor immune microenvironment simultaneously. In preclinical studies, SKB103 demonstrated outstanding anti-tumor activity and a favorable 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 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."
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. Kelun-Biotech focuses on major disease areas such as solid tumors, 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, 1 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 ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
source: Kelun-Biotech
【你點睇？】日本放寬武器出口限制，原則上允許出口具殺傷力武器，你認為中國會否推出強力反制措施？ ► 立即投票
