Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501

Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its cancer drug candidate SIM0501, intended for the treatment of advanced solid tumors. SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is significantly overexpressed in various types of tumors and plays a pivotal role in DNA damage response and repair mechanisms. By inhibiting USP1, SIM0501 can promote tumor apoptosis, particularly in homologous recombination deficient (HRD) tumors.

Preclinical pharmacological studies, both in vitro and in vivo, have demonstrated that SIM0501 exhibits significant anti-proliferative activity against HRD tumors, whether administered as a monotherapy or in combination with PARP inhibitors. This highlights the drug’s high potential for clinical development. Notably, SIM0501 was cleared for clinical trials in the US just last month, indicating its rapid progression towards global clinical evaluation.- Flcube.com

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