Ascentage Pharma is committed to develop investigational new drugs that transform the lives of patients suffering from cancers, chronic hepatitis B, and age-related diseases. These include potential innovative therapies to manage diseases/conditions that are otherwise difficult to treat. Central to Ascentage Pharma’s vision of enhancing patients’ lives is our pledge to bring these novel targeted therapies to patients as rapidly as possible.
While fulfilling this pivotal aim, we are also mindful of patient safety and the imperative to abide by proven safeguards to protect health and well-being. As we develop innovative therapies to treat a range of diseases/conditions, we are making our investigational drugs available to patients via participation in one of our many clinical trials under the supervision of health care authorities and Institutional Review Board.
Once clinical evidence supporting the safety and efficacy of our therapies has met the formal scientific evaluations, we will start considering requests for our investigational drugs outside of clinical trials through our expanded-access program. Our expanded-access program will include independent review by the US Food and Drug Administration.
We will announce specific expanded-access programs involving our therapies well in advance of respective market launches and according to the following principles:
- Our program will be consistent with country-/region-specific Regulatory Agency guidelines and approval processes,
- Each access request must come from a qualified, treating physician and will be considered on a case-by-case basis using a fair and equitable process,
- The requesting physician must certify that the patient meets the product-specific criteria and guidelines defined by Ascentage Pharma for expanded access/compassionate use,
- The risk-benefit of receiving the Ascentage Pharma investigational drug must be assessed and confirmed by the requesting physician and will be further assessed by Ascentage Pharma,
- The requesting physician must certify that competent health care facilities will be available to the patient that are appropriate to administer therapy, manage potential side effects, and monitor the patient with appropriate follow-up,
- Informed consent as well as regulatory and institutional approvals must be secured by the requesting physician in order to act on any request lawfully and responsibly,
- The expanded-accessprogram will not impede the initiation, ongoing progress, or completion of clinical trials or regulatory filings associated with the therapy,
- Adequate supply of the product/therapy exists, manufacturing capability is maintained for ongoing programs, and it is logistically possible for Ascentage Pharma to make the therapy available outside of a clinical trial setting, and
- Our programs will support use of Ascentage Pharma therapies for the indicated
disease/condition under investigation and will not be available to treat other diseases/conditions.
