Dec 16th, 2024
- HS-20093/GSK’227 receives EMA Priority Medicines (PRIME) Designation in relapsed extensive-stage small-cell lung cancer (“ES-SCLC”) .
Hansoh Pharma (03692.HK) announced that its Partner GSK has received European Medicines Agency (EMA) Priority Medicines (PRIME) Designation for GSK5764227 (GSK’227, also known as HS-20093), the B7-H3-targeted antibody-drug conjugate (“ADC”) being evaluated for the treatment of patients with relapsed extensive-stage small-cell lung cancer (“ES-SCLC”) .
The EMA’s PRIME Designation is supported by preliminary clinical data from the ARTEMIS-001 study. This is an ongoing phase I open-label, multi-centre trial of more than 200 patients evaluating the safety, tolerability, and preliminary anti-tumour activity in locally advanced or metastatic solid tumours, including relapsed or refractory ES-SCLC, conducted by Hansoh Pharma. The efficacy and safety results from this trial were presented at the 2024 World Conference on Lung Cancer earlier this year. GSK recently began a global phase I trial to support a registrational pathway for GSK’227.
Earlier this year, the U.S. FDA granted Breakthrough Therapy Designation to GSK’227 for ES-SCLC patients with disease progression on or after platinum-based chemotherapy. Meanwhile, China's NMPA listed HS-20093 as a Breakthrough-Therapy-Designated Drug for ES-SCLC following first-line platinum-doublet chemotherapy and immunotherapy.
About HS-20093
HS-20093 is a novel investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload and being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumors in multiple phase I, II and III clinical trials in China.
On December 20, 2023, Hansoh Pharma entered into a license agreement with GSK, granting GSK an exclusive global license (excluding Chinese mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize HS-20093. GSK’s global phase I trial for GSK’227 began in August 2024.
