Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE). The designation is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC) in patients who have failed previous EGFR-TKI therapy. This marks a significant milestone in the development of SKB264, which was previously awarded BTD for its potential use against locally advanced or metastatic triple-negative breast cancer in China.
Breakthrough Therapy Designation and Clinical Data
The BTD for SKB264 was awarded based on Phase II expansion study data, highlighting the drug’s potential to address significant unmet medical needs in advanced NSCLC. As an ADC, SKB264 delivers a cytotoxic payload directly to tumor cells by targeting the TROP2 antibody, aiming to reduce off-target toxicity while improving efficacy and safety. The drug is currently undergoing Phase II and III clinical trials for multiple tumor types in both China and the US.
Global Licensing Agreement
In May 2022, Kelun Pharma entered into a USD 1.41 billion licensing agreement with Merck Sharp & Dohme Corp. Under the agreement, Merck gained development and commercial rights to SKB264 for territories outside of Greater China. This strategic partnership underscores the global potential of SKB264 and positions Kelun to further expand its reach in oncology treatments.-Fineline Info & Tech
