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Release time:2023-12-05

December 5, 2023, Simcere Zaiming Pharmaceutical Co., Ltd. (“Simcere Zaiming"), an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd., announced that it has received approval by the U.S. Food and Drug Administration (FDA) for an Investigational New Drug Application (IND) for SIM0501, a small-molecule inhibitor of Ubiquitin Specific Peptidase 1 (USP1) and an anti-tumor drug candidate independently developed by the company. SIM0501 is intended to be investigated in the clinical trials for advanced solid tumors.


"SIM0501 is the third asset developed independently by Simcere Zaiming that has been approved for clinical development in the United States.” said Dr Renhong TangPhD., Chairman of Simcere Zaiming. ”This molecule targets USP1 and is expected to trigger synthetic lethality in homologous recombination deficient (HRD) tumors through a pathway different with and complement to the PARP inhibitors. It has the potential to overcome the resistance problem arising with PARP inhibitors. We will advance its global clinical development with full efforts and look forward to bringing new options for a wider range of oncology patients. ”


USP1 is a deubiquitinating enzyme that promotes DNA repair through multiple pathways. USP1 is significantly overexpressed in many cancers, while the blockage of USP1 inhibits DNA repair in some tumor cells, especially in HRD tumors, and consequently causes tumor cell apoptosis. Some studies have also shown that inhibition of USP1 or downstream signaling pathways leads to enhanced sensitivity of HRD tumor cells to poly ADP-ribose polymerase (PARP) inhibitors. USP1 is therefore considered a promising synthetic lethal target for the treatment of tumors harboring HRD mutations with possible synergy with PARP inhibitors.


SIM0501 is a small molecule independently developed by Simcere Zaiming. It can be orally given and is a non-covalent highly selective USP1 inhibitor. As demonstrated by preclinical in vitro and in vivo models, the candidate has significant anti-proliferative activity against HRD tumors as a single agent or in combination with PARP inhibitors. In addition to IND in the US, the IND application of SIM0501 in China was accepted by the National Medical Products Administration (NMPA) of China on October 27, 2023.

About Simcere Zaiming

Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited. Founded in 2023, the Company is committed to developing disruptive therapies that have the potential to address unmet clinical needs for cancer patients around the world. Simcere Zaiming has built an innovative R&D pipeline, with differentiated clinical values. Several products of Zaiming are commercially available in China, which include COSELA®, Endostar®, and Envafolimab. Simcere Zaiming strives to bring potentially breakthrough treatments options to cancer patients worldwide through in-house R&D, manufacturing and commercialization, as well as collaborations with global partners of innovative cancer therapeutics. pr@zaiming.com