Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in October of this year.
SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is significantly overexpressed in various tumors and plays a key role in DNA damage response and repair mechanisms. Inhibiting USP1 can induce tumor apoptosis, particularly in homologous recombination deficient (HRD) tumors. Preclinical pharmacological studies have demonstrated that SIM0501, both as a monotherapy and in combination with PARP inhibitors, exhibits significant anti-proliferative activity against HRD tumors, highlighting its potential for clinical development.
Additionally, the Chinese company disclosed that its PD-L1 monoclonal antibody (mAb) envafolimab has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) for the treatment of non MSI-H/non dMMR advanced endometrial cancer in patients who have failed or are intolerant to first-line platinum-containing chemotherapy in combination with lenvatinib.
Envafolimab, the world’s first single-domain PD-L1 antibody and a human IgG1 Fc fusion protein capable of subcutaneous injection, was originated by Alphamab Oncology (HKG: 9966) with 3D Medicines as a co-development partner under a January 2019 agreement. Simcere Pharmaceutical Group joined the alliance in March 2020, taking on exclusive responsibility for the commercial promotion of the drug in mainland China. The drug was approved to treat unresectable or metastatic advanced solid tumors with MSI-H/dMMR in China in November 2021.- Flcube.com
