Hansoh Pharma’s HS-20093 receives Breakthrough Therapy Designation from NMPA for Osteosarcoma

CAR-T Digest - August 2020

25 Feb 2025: Hansoh Pharma’s HS-20093 receives Breakthrough Therapy Designation from NMPA for Osteosarcoma

Hansoh Pharma’s B7-H3-targeted ADC, HS-20093, has been granted Breakthrough Therapy Designated Drug status by China’s NMPA for treating osteosarcoma patients who have progressed on at least two prior therapies
HS-20093 is an investigational ADC composed of a fully human anti-B7-H3 mAb linked to a topoisomerase inhibitor (TOPOi) payload and is being evaluated for multiple solid tumors, including lung cancer, sarcoma, and head and neck cancers
The ADC is undergoing several clinical trials in China, with its most advanced study currently in Phase 3
On November 1, 2024, the NMPA also granted HS-20093 Breakthrough-Therapy-Designated Drug status for extensive-stage small-cell lung cancer (ES-SCLC) after progression following first-line platinum doublet chemotherapy and immunotherapy
Osteosarcoma, the most common primary malignant bone tumor, is classified as a rare disease in China and has a poor prognosis, with a five-year survival rate of only 20% in advanced cases