HS-20093, B7-H3-TARGETED ANTIBODY-DRUG CONJUGATE, RECEIVES EMA PRIORITY MEDICINES DESIGNATION.
- HS-20093/GSK’227 receives EMA Priority Medicines (PRIME) Designation in relapsed extensive-stage small-cell lung cancer (“ES-SCLC”) .
SHANGHAI, Dec 16, 2024 — 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.
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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.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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