On November 1st, 2024, Hansoh Pharma (03692.HK) announced that its self-developed B7-H3 targeted antibody-drug conjugate ("ADC") injection HS-20093 has been approved by the China National Medical Products Administration (NMPA) as a breakthrough therapeutic drug, indicated for extensive-stage small cell lung cancer ("ES-SCLC") progressing after standard first-line treatment (including platinum doublet chemotherapy in combination with immunotherapy).
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. It is currently undergoing Phase III clinical studies in China for small cell lung cancer, as well as Phase I and II studies for sarcoma, head and neck cancer, and other solid tumors.
On December 20th, 2023, the group entered into a licensing agreement with GlaxoSmithKline Intellectual Property (No.4) Limited ("GSK"), granting GSK exclusive global rights (excluding China) to develop, manufacture, and commercialize HS-20093 (also known as GSK5764227). GSK is currently conducting global Phase I clinical trials for the drug. On August 20th, 2024, GSK announced that the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to GSK5764227 for the treatment of patients with (relapsed or refractory) ES-SCLC progressing during or after platinum-based chemotherapy.
