I-Mab Biopharma (NASDAQ: IMAB) strives to address unmet medical needs in oncology using cutting-edge technology to fine-tune the immune network in cancers.

Expanded Access Policy

The U.S. Food and Drug Administration (FDA) has established criteria for the provision of investigational medicines to patients outside of clinical trials (compassionate use/expanded access). Guidance from the FDA provides that expanded access is a potential pathway for a patient when all of the following apply:

  • The patient has a serious disease or condition or whose life is immediately threatened by their disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.

Currently, I-Mab is not accepting applications for expanded access of our investigational medicines. For patients seeking access to our investigational medicines before they are approved by a regulatory authority, participation in one of I-Mab’s clinical trials is the most appropriate path. To learn more about available clinical trials by I-Mab, please visit https://clinicaltrials.gov and search by company, disease or medicine.

If you have additional questions, please speak with your physician or contact info@imabbio.com.

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