CSPC：SYS6043 is proposed to be granted Breakthrough Therapy designation.
On June 24, the CDE official website announced that CSPC Pharmaceutical Group’s Category 1 new drug SYS6043 has been proposed for Breakthrough Therapy designation, with the indication being platinum-resistant ovarian cancer, primary peritoneal cancer, and fallopian tube cancer.
SYS6043 is a B7-H3-targeting antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload, a drug-to-antibody ratio (DAR) of approximately 6, and employs Fcγ receptor effector-silencing design and a cleavable linker, aimed at enhancing anti-tumor activity while reducing off-target toxicity. B7-H3 is widely and highly expressed across multiple tumor types but is rarely expressed in normal tissues.
At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, CSPC Pharmaceutical Group presented Phase I clinical data for SYS6043 in an oral presentation. This is a multicenter, open-label, single-arm Phase I/II clinical study conducted in China (ChiCTR2400094683) designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of SYS6043 in patients with advanced solid tumors.
Preliminary analysis results from the Phase I study showed that B7-H3 expression levels were not significantly correlated with the efficacy of SYS6043. SYS6043 demonstrated generally good tolerability, with only 2 dose-limiting toxicities (DLTs) observed in the 10 mg/kg Q3W dose group, consisting of one Grade 3 gastrointestinal disorder and one Grade 4 febrile neutropenia. Treatment-related adverse events (TRAEs) occurred in 96.7% of patients. The incidence of Grade ≥3 TRAEs was 37.2%, which was relatively low and predominantly hematological in nature, with the most common TRAEs being anemia (16.1%), neutropenia (12.6%), and leukopenia (9.7%), while all other Grade ≥3 TRAEs occurred at rates ≤3.5%.
Based on the positive results of this study, CSPC Pharmaceutical Group is actively advancing further research in ovarian cancer, breast cancer, and small cell lung cancer.
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