Expanded Access Policy
SHENZHEN IONOVA LIFE SCIENCE CO., LTD. (hereinafter referred to as "IONOVA") is a clinical-stage biotech company dedicated to developing next-generation cancer therapeutics that offer distinct clinical benefits and global competitiveness. IONOVA conducts human clinical trials for its investigational products to generate safety and efficacy data as required to support the regulatory approval by the U.S. Food and Drug Administration (FDA) and regulatory authorities in other countries and subsequent wider accessibility to patients.
Expanded Access (sometimes referred as compassionate use) is a potential pathway for patients without satisfactory alternatives and unable to enroll in a clinical trial to receive an investigational product outside of a study, where all criteria are met and local laws/regulations allow.
We support the need for an expanded access program, and our goal is to provide expanded access to our investigational products at the appropriate time in development. Considering the stage of development of the investigational products, IONOVA is seeking to retain its capacity of manufacturing and drug supply to assure adequate supply to ongoing clinical trials and development programs to generate data on the safety and efficacy of the investigational products in order to support regulatory approval and make the products accessible to the broader patient population. At this time, IONOVA is unable to provide any of its investigational drug products on an expanded access or right-to-try basis. We encourage patients to speak with their physicians and to participate in the available clinical trials.
Contact Details
If you have any questions about our expanded access policy, please contact Ionova via email at: ra@ionovabio.com. We will use our best efforts to acknowledge each submitted question within 5 business days from receipt.
For Additional Information
For more information on the available clinical trials, please visit clinicaltrials.gov and search company, condition, or treatment.
For more information about expanded access in the U.S., visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.
This policy is published on IONOVA’s website and may be revised at any time. Availability of Expanded Access is not guaranteed for any specific request and does not constitute an offer to treat outside applicable regulations.
Publication Date: 2025-11-04
