Hansoh Pharmaceutical (03692) Announces NMPA Approval of B7-H3-Targeted ADC HS-20093 as Breakthrough Therapy for Extensive-Stage Small Cell Lung Cancer

Hansoh Pharma (03692) announced that on November 1, 2024, HS-20093 for injection, a self-developed B7-H3-targeted antibody-drug conjugate (ADC) by the group, was approved by the National Medical Products Administration (NMPA) of China for inclusion in the breakthrough therapy designation. The proposed indication is for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after standard first-line treatment (platinum doublet chemotherapy combined 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 trials in China for small cell lung cancer, as well as multiple Phase I and II studies for sarcoma, head and neck cancer, and other solid tumors.

On December 20, 2023, Hansoh Pharmaceutical Group Company Limited ("the Group") entered into a licensing agreement with GlaxoSmithKline Intellectual Property (No. 4) Limited ("GSK"), granting GSK an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize HS-20093 (also known as GSK5764227), which is currently undergoing a global Phase I clinical trial conducted by GSK. On August 20, 2024, GSK announced that the U.S. Food and Drug Administration (FDA) had granted GSK5764227 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).