CSPC Pharmaceutical Group Limited (CSPC Pharma) announced that its internally developed antibody–drug conjugate (ADC) SYS6010 has received a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for use as a monotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed prior platinum-based chemotherapy and immunotherapy.

According to GLOBOCAN 2022 data, ESCC is the dominant subtype of esophageal cancer in China, accounting for more than 90 % of cases in the country’s high-incidence regions. The National Cancer Center reported 224,000 new ESCC cases and 188,000 related deaths in China during 2022, each representing roughly half of the global burden. Current second-line options—primarily docetaxel and irinotecan—deliver limited objective response rates and short median overall survival, underscoring significant unmet medical need.

Clinical studies of SYS6010 for the target indication have shown what CSPC Pharma describes as “breakthrough efficacy” and a favorable safety profile relative to existing standard therapies. The company has already initiated a Phase III confirmatory trial in ESCC and is conducting multiple Phase III studies across additional solid-tumor indications, including first-line and second-line non-small cell lung cancer (NSCLC) and later-line breast cancer.

This marks the second BTD for SYS6010; the NMPA previously granted the designation in January 2025 for EGFR-mutant resistant NSCLC. CSPC Pharma expects the latest BTD to accelerate clinical development and regulatory review, potentially expediting market entry and strengthening its oncology pipeline and competitive position in ADC therapeutics.