Expanded Access Policy

Release time:2023-12-01

Shanghai Miracogen Inc. (Miracogen) is a biopharmaceutical company focusing on development of innovative antibody-drug conjugates (ADC) and bringing new therapies for patients with various cancers. Miracogen 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.

With the enactment of the FDA Reauthorization Act and 21st Century Cures Act, the FDA greenlights the early access of investigational medicinal products on an Expanded Access basis for patients facing serious or immediately life-threatening diseases or conditions who are ineligible or unable to participate in a clinical trial and may not have options for alternative therapies. Meanwhile, the statute aims to make it easier for patients and physicians to understand a drug manufacturer’s policies regarding the availability of its investigational drug products for expanded access, how to request access, and how requests will be handled.

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, Miracogen 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, Miracogen 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 Miracogen via email at: expanded_access@miracogen.com.cn.

For Additional Information

For more information on the available clinical trials, please visit clinicaltrials.gov and search company, condition, or treatment.

For additional information on Expanded Access, please visit the U.S. Food and Drug Administration at: Expanded Access | FDA.

The publication of this policy by Miracogen is not a guarantee of access to any specific investigational product by any individual patient. In line with the 21st Century Cures Act, Miracogen may revise this policy at any time.