SKB-103

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) announced that its Investigational New Drug application for SKB103, a tumor associated antigen (TAA)/PD-L1 bispecific antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation of China’s National Medical Products Administration. SKB103 is the company’s first TAA-PD-L1 bispecific ADC candidate and its second bispecific ADC program to enter clinical development, following SKB571, an EGFR/c-Met-targeted ADC that is under co-development with Merck & Co. The IND approval permits Kelun-Biotech to initiate clinical trials in patients with advanced solid tumors in China. SKB103 is designed as a single molecule that combines targeted delivery of a cytotoxic payload via a TAA arm with immune checkpoint modulation via a PD-L1-binding arm. The specific TAA targeted by SKB103 has not been publicly disclosed. No IND filings to the US FDA or other regulatory authorities have been reported for SKB103. SKB103 enters a field defined by two converging trends in oncology drug development: the expansion of antibody-drug conjugates across solid tumor types and the effort to integrate immune checkpoint modulation into targeted delivery platforms. Approved monospecific ADCs such as trastuzumab deruxtecan (Enhertu, Daiichi Sankyo/AstraZeneca) and sacituzumab govitecan (Trodelvy, Gilead Sciences) have established the ADC modality across multiple solid tumor indications, while checkpoint inhibitors including pembrolizumab (Keytruda, Merck) and atezolizumab (Tecentriq, Roche) remain standard-of-care treatments. No bispecific ADC has yet received regulatory approval in any market. Kelun-Biotech has two marketed ADC products in China, a TROP2 ADC (sacituzumab tirumotecan) and a HER2 ADC (trastuzumab botidotin), and maintains licensing agreements with Merck & Co. covering other ADC candidates, though SKB103 has not been linked to any external partnership. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website