HANSOH PHARMA: B7-H3 targeted antibody-drug conjugate HS-20093 received FDA breakthrough therapy designation for relapsed or refractory osteosarcoma in later lines of treatment

Zhitong
2025.01.07 11:20
portai
I'm PortAI, I can summarize articles.

HANSOH PHARMA announced that its B7-H3 targeted antibody-drug conjugate HS-20093 has received Breakthrough Therapy designation from the U.S. FDA for patients with relapsed or refractory osteosarcoma. The drug is covalently linked with a fully human anti-B7-H3 monoclonal antibody and a topoisomerase inhibitor payload, and is currently undergoing multiple clinical studies in China, covering various solid tumors including lung cancer, sarcoma, and head and neck cancer

According to the Zhitong Finance APP, HANSOH PHARMA (03692) announced that GSK has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for GSK5764227 (GSK’227, also known as HS-20093). This B7-H3 targeted antibody-drug conjugate (ADC) is being evaluated for the treatment of adult patients with recurrent or refractory osteosarcoma (bone cancer) who have progressed after prior second-line and above treatments.

HS-20093 is a novel B7-H3 targeted ADC, covalently linked by a fully human anti-B7-H3 monoclonal antibody and a topoisomerase inhibitor (TOPOi) payload, and is currently undergoing multiple Phase I, II, and III clinical studies in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors