2025/ 05/20

CSPC Innovation’s SYS6010 (CPO301) Antibody-Drug Conjugate Granted Fast Track Designation by the U.S. FDA

On May 19, CSPC Innovation Pharmaceutical Co., Ltd. announced that SYS6010 (CPO301), developed by JW Therapeutics Co., Ltd., a subsidiary held by the Company, has recently been granted **Fast Track Designation (FTD)** by the U.S. Food and Drug Administration (FDA). The indication is for the treatment of adult patients with advanced or metastatic non-squamous non-small cell lung cancer (Nsq-NSCLC) **without epidermal growth factor receptor (EGFR) mutations or other driver gene alterations (AGA)**, whose disease has progressed following prior platinum-containing chemotherapy and anti-PD-(L)1 therapy.

YS6010 (CPO301) is an antibody-drug conjugate (ADC) targeting the EGFR tumor-associated antigen. By binding to the target antigen on the surface of tumor cells, the drug is internalized into cells to release small-molecule toxins that kill tumor cells.The drug has obtained clinical trial approval in both China and the United States, with related clinical trials underway.This marks the third Fast Track Designation granted by the U.S. FDA for this drug:

  • The first was awarded in June 2023 for the treatment of patients with metastatic EGFR-mutant non-small cell lung cancer (NSCLC) that is relapsed/refractory following EGFR-targeted therapy (including third-generation EGFR inhibitors such as osimertinib) or ineligible for EGFR-targeted therapy.

  • The second was granted in September 2024 for the treatment of patients with recurrent or metastatic squamous non-small cell lung cancer (Sq-NSCLC) with high EGFR expression whose disease has progressed during or after platinum-based chemotherapy and anti-PD-(L)1 therapy.