On December 4th, Gelonghui: Fosun Pharma (600196.SH) announced that its controlling subsidiary, Shanghai Henlius Biomedical Technology Co., Ltd. and its controlling subsidiaries (collectively referred to as "Henlius"), recently received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX43 for injection (i.e. targeted PD-L1 antibody - novel DNA topoisomerase I inhibitor conjugate drug, referred to as "the new drug") in monotherapy or combination therapy for advanced/metastatic solid tumors. Henlius plans to conduct related clinical trials for the new drug in mainland China (excluding the Hong Kong, Macao, and Taiwan regions) once conditions are met.
The new drug is an ADC (antibody-drug conjugate) jointly developed by this group (i.e. this company and its holding subsidiaries/units) by coupling a novel DNA topoisomerase I inhibitor small molecule toxin-peptide linker imported under license from Suzhou Yilean Biomedical Co., Ltd. with the group's independently developed antibody targeting PD-L1 for the treatment of advanced/metastatic solid tumors. As of the date of this announcement (i.e. December 4, 2024), the new drug has been undergoing Phase I clinical studies for the treatment of advanced/metastatic solid tumors in mainland China. In addition, in November 2023, the application for Phase I clinical trial of this new drug for the treatment of advanced/metastatic solid tumors was approved by the US Food and Drug Administration (FDA).
