On April 17,2025,Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK),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.
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.
About HS-20093
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.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 the product began in August 2024.
About Lung Cancer
Lung cancer is the cancer with the highest global mortality rate. According to the latest data from the National Cancer Centre, there were 1.06 million new cases of lung cancer and 733,000 deaths from lung cancer in China in 2022. Both the incidence and mortality rates of lung cancer rank first among all cancers[1]. NSCLC accounts for approximately 80-85% of lung cancer cases in China[2,3], with around 70% being nsNSCLC.
Reference：
[1] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024.
[2] 中华医学会肿瘤学分会，中华医学会杂志社. 中华医学会肺癌临床诊疗指南（2023版）. 中国综合临床，2023，39(06):401-423.
[3] 中国抗癌协会肺癌专业委员会，中华医学会肿瘤学分会肺癌学组. Ⅲ期非小细胞肺癌多学科诊疗专家共识(2019版). 中华肿瘤杂志，2019，41(12):881-890.
