On May 1,2025,Hansoh Pharmaceutical announces that the Group’s self-developed B7-H4-targeted antibody-drug conjugate (ADC) HS-20089 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 platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer patients.
The designation is supported by results from the Phase I HS-20089-101 study and the Phase II HS-20089-201 study. The HS-20089-101 study is a multi-center, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HS-20089 for injection in patients with advanced solid tumors. The HS-20089-201 study is a multi-center, open-label Phase II clinical trial to evaluate the efficacy, safety, pharmacokinetic profile, and immunogenicity of intravenous HS-20089 in patients with recurrent or metastatic ovarian cancer and endometrial cancer.
HS-20089 is a B7-H4-targeted ADC with a topoisomerase inhibitor (TOPOi) payload being developed for the treatment of ovarian cancer and other gynecological tumors in multiple clinical trials in China, with the highest research stage being Phase III clinical trials. B7-H4 is a transmembrane immune checkpoint glycoprotein that is highly expressed in multiple solid tumors, including endometrial cancer and ovarian cancer, but with limited expression in normal tissues.
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.
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Post time: May-09-2025