Hansoh Pharma's $1.7B Licensed-Out ADC HS-20093 Receives FDA Breakthrough Therapy Designation for Relapsed/Refractory Osteosarcoma

Jan 08, 2025 11:38 CST Updated 11:38

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

GSK

Pharmaceutical R&D Manufacturer

On January 7, Hansoh Pharma announced,Collaboration Partner GSK Receives FDA Breakthrough Therapy Designation (BTD) for GSK5764227 (HS-20093)。

This drug is a B7-H3-targeted antibody-drug conjugate (ADC) currently under evaluation.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.。

This FDA Breakthrough Therapy Designation is supported by the data from Hansoh Pharma's ongoing ARTEMIS-002 study.

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 has enrolled more than 60 patients, including 42 with osteosarcoma. The results of 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 for HS-20093/GSK'227, which has previously received regulatory designations in China, the U.S., and Europe, with specific information as follows:

About HS-20093

HS-20093(GSK'227) is a novel B7-H3-targeted antibody-drug conjugate (ADC), covalently linked by a fully human anti-B7-H3 monoclonal antibody and 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 a worldwide exclusive license (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize HS-20093(GSK'227).

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