The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2 negative breast cancer that has previously received at least second-line systemic chemotherapy.
SKB264’s ADC Mechanism and Existing BTD Awards
As an ADC, SKB264 directly delivers a cytotoxic payload to tumor cells via the TROP2 antibody, aiming to reduce off-target toxicity while enhancing efficacy and safety. The drug has already earned BTD awards for the treatment of locally advanced or metastatic triple negative breast cancer and locally advanced or metastatic non-small cell lung cancer with EGFR mutation (NSCLC) after EGFR-TKI treatment failure.
Clinical Trials and Global Expansion
SKB264 is currently undergoing Phase II and III clinical trials for multiple tumor types in China and the US. This global clinical development is part of the drug’s expansion strategy. In May 2022, Kelun Pharma entered into a licensing agreement with Merck Sharp & Dohme Corp (MSD, NYSE: MRK), valued at USD 1.41 billion. This agreement granted the US major development and commercial rights to SKB264 for territories outside of Greater China, marking a significant step in the drug’s international reach.-Fineline Info & Tech
