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  • Expanded Access Policy for Sugemalimab (CS1001)

    Times:2020.10.28   Author:CStone

    CStone Pharmaceuticals (Suzhou) Co., Ltd. (CStone) is a biopharmaceutical company committed to bringing innovative therapies to patients by conducting clinical trials and obtaining marketing approval by the US Food and Drug Administration (FDA), China National Medical Products Administration (NMPA) and other regulatory authorities. Sugemalimab, an anti-PD-L1 monoclonal antibody, is currently investigated in a Phase 2 clinical trial for subjects with relapsed or refractory extranodal natural killer/ T cell lymphoma (R/R ENKTL), as well as other Phase 1-3 trials indicated for a variety of hematologic malignancies and solid tumors.


    Expanded Access, which is sometimes known as “compassionate use”, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational therapy for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.  For more information about expanded access in the US, please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.


    CStone focuses on conducting clinical trials aimed at gaining regulatory approval, making sugemalimab available to patients as quickly as possible. We seek to retain the ability to manufacture and supply sugemalimab in a fair and equitable manner and in a volume that assures adequate supply for ongoing clinical trials and development programs. As such, CStone believes participation in clinical trials is the most appropriate way to receive sugemalimab for patients seeking access before it is approved by a regulatory authority, and we do not offer any Expanded Access programs for sugemalimab at this time. Please visit https://clinicaltrials.gov and search by company, disease or medicine.


    Consistent with the 21st Century Cures Act, CStone may revise this policy at any time.