Hansoh Pharmaceutical's HS-20093 (GSK5764227) Receives FDA Breakthrough Therapy Designation for Relapsed or Refractory Osteosarcoma

On January 7, Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma") announced that its partner, GlaxoSmithKline (GSK), had received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for GSK5764227 (GSK'227, also known as HS-20093). The drug is a B7-H3-targeted antibody-drug conjugate (ADC) currently being evaluated for the treatment of adult patients with advanced recurrent or refractory osteosarcoma (bone cancer) who have progressed after two or more prior lines of therapy.

HS-20093(GSK'227) is a novel B7-H3-targeted antibody-drug conjugate (ADC), composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. It is currently undergoing multiple Phase I, II, and III clinical trials in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors. On December 20, 2023, Hansoh Pharma entered into an exclusive licensing agreement with GSK, granting GSK global exclusive rights (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize HS-20093(GSK'227).

The breakthrough therapy designation by the FDA was supported by the ongoing ARTEMIS-002 study data from Hansoh Pharma. This is an ongoing Phase II, open-label, randomized, multicenter clinical trial evaluating the efficacy and safety of HS-20093/GSK'227 in patients with recurrent or refractory osteosarcoma and other unresectable bone and soft tissue sarcomas. The trial enrolled over 60 patients, including 42 with osteosarcoma. Results from ARTEMIS-002 were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Recently, GSK initiated a global Phase I clinical trial to support the registrational study of GSK'227.

This is the fourth regulatory designation received by HS-20093/GSK'227. Previously, HS-20093/GSK'227 had already obtained regulatory designations in China, the United States, and Europe. In August 2024, the U.S. Food and Drug Administration (FDA) granted GSK'227 Breakthrough Therapy Designation for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed during or after platinum-based chemotherapy (recurrent or refractory). In November 2024, the China National Medical Products Administration (NMPA) included HS-20093 in the list of breakthrough therapies, with the proposed indication being ES-SCLC that has progressed after standard first-line treatment (platinum doublet chemotherapy combined with immunotherapy). In December 2024, the European Medicines Agency (EMA) granted GSK'227 Priority Medicines (PRIME) designation for the treatment of recurrent ES-SCLC.