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.
Consistent with CStone’s mission, our development resources are focused on conducting clinical trials required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of sugemalimab, and to gain regulatory approvals to make sugemalimab available broadly to patients as quickly as possible. To reach this goal successfully, our top priorities must be to ensure that an adequate supply of sugemalimab is available for those patients in our clinical trials and that drug supply will not hinder us from completing the clinical studies and obtaining regulatory approvals that will lead to wider patient access. As such, CStone does not provide any Expanded Access programs for sugemalimab outside of clinical trials at this time. Please visit https://clinicaltrials.gov and search by company, disease or medicine for applicable clinical trials.
Consistent with the 21st Century Cures Act, CStone may revise this policy at any time.