On September 7th, the CDE website revealed that SYS6010, developed by CSPC PHARMA, has been proposed for inclusion in the breakthrough therapy designation program. This designation is intended for the treatment of recurrent or metastatic driver-gene-negative non-squamous non-small cell lung cancer (NSCLC) in patients who have failed prior immunotherapy and platinum-based chemotherapy regimens.

SYS6010 is an EGFR-targeted antibody-drug conjugate (ADC) developed by Jushi Biologics, a subsidiary under CSPC Innovative Pharmaceuticals. The drug is constructed by conjugating a humanized anti-EGFR monoclonal antibody to a topoisomerase I inhibitor payload via a cleavable linker. Upon administration, it specifically binds to EGFR receptors on the surface of tumor cells, undergoes internalization, and subsequently releases the cytotoxic payload intracellularly, thereby exerting its antitumor effects.

The drug has demonstrated particularly potent antitumor activity in humanized non-small cell lung cancer PDX models harboring EGFR triple mutations (Exon19Del, T790M, and C797S), which confer resistance to third-generation EGFR-TKIs like osimertinib. Preclinical toxicology and safety pharmacology studies have shown that SYS6010 possesses a favorable safety profile and good tolerability.

Results from a Phase I study indicated that in previously treated EGFR wild-type non-squamous NSCLC patients (n=42), treatment with SYS6010 yielded an objective response rate (ORR) of 35.7%, a disease control rate (DCR) of 88.1%, a median progression-free survival (PFS) of 5.3 months, and a median overall survival (OS) that had not yet been reached, with 61.5% of patients surviving at the one-year mark. In previously treated EGFR wild-type squamous NSCLC patients (n=20), the ORR was 20.0%, the DCR was 75.0%, the median PFS was 2.9 months, and the median OS had not been reached, with 59.1% of patients achieving one-year survival.

Additionally, in the same study, EGFR-mutant NSCLC patients who had received prior EGFR-TKI therapy (n=46) demonstrated an ORR of 45.7%, a DCR of 95.7%, and a median PFS of 7.8 months, with median OS not yet reached. Among EGFR-mutant NSCLC patients who had received both EGFR-TKI and platinum-based chemotherapy (n=98), the ORR was 34.7%, the DCR was 93.9%, the median PFS was 7.6 months, and the median OS was 19.4 months.

Previously, SYS6010 had already received three breakthrough therapy designations from the National Medical Products Administration (NMPA): firstly, as a monotherapy for advanced NSCLC patients with EGFR mutations who have failed prior EGFR-TKI and platinum-based chemotherapy; secondly, as a monotherapy for patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who have failed prior EGFR-TKI and platinum-based chemotherapy; and thirdly, as a monotherapy for patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior EGFR-TKI and platinum-based chemotherapy.

In August 2026, the Phase III study of SYS6010 in EGFR-mutant locally advanced or metastatic NSCLC patients who had failed prior EGFR-TKI therapy reached its primary endpoint. This marked the first Phase III clinical trial results to be disclosed for this drug candidate.