On April 17,2025,Hansoh Pharmaceutical announces that the Group’s self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver mutations, progressed or recurred following platinum-based chemotherapy.
HS-20093 is an investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload and being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumors in multiple clinical trials in China, with the highest research stage being Phase Ⅲ clinical trials.
The 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 300 patients evaluating the safety, tolerability, and preliminary anti-tumour activity in locally advanced or metastatic solid tumor ( locally advanced or metastatic non-squamous non-small cell lung cancer without driver mutations, progressed or recurred following platinum-based chemotherapy), conducted by Hansoh Pharma.
Previously, HS-20093 has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the NMPA for two indications：
·Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) developed after standard first-line treatment (platinum doublet chemotherapy combined with immuno-therapy).
·Osteosarcoma in patients who have progressed on at least two prior lines of therapy.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
Post time: Apr-22-2025