HS-20093 granted Breakthrough Therapy Designation by NMPA for Esophageal cancer treatment

CAR-T Digest - August 2020

11 May 2026: HS-20093 granted Breakthrough Therapy Designation by NMPA for Esophageal cancer treatment

Hansoh Pharma has secured another important regulatory milestone after China’s NMPA granted Breakthrough Therapy Designation to its B7-H3-targeted ADC HS-20093 for patients with unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed with first-line platinum-based chemotherapy and immune checkpoint inhibitors (ICI) treatment
The designation highlights the growing interest in B7-H3 as a next-generation ADC target, particularly in difficult-to-treat solid tumors where treatment options remain limited after progression on standard chemo-immunotherapy regimens
The Breakthrough Therapy status could accelerate clinical development and regulatory review for HS-20093 in China, potentially helping bring the ADC to ESCC patients faster if ongoing studies continue to demonstrate meaningful clinical benefit
With this latest designation, Hansoh continues strengthening its position in the competitive ADC landscape, as Chinese biopharma companies increasingly push forward next-generation oncology programs targeting novel antigens beyond HER2 and TROP2
HS-20093 is part of Hansoh’s expanding ADC pipeline and reflects broader industry momentum toward B7-H3-directed therapies, which are being explored for their potential to deliver targeted cytotoxic activity across multiple tumor types with high unmet need