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.
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.
If you have any questions about our expanded access policy, please contact Miracogen via email at: expanded_access@miracogen.com.cn.
For more information on the available clinical trials, please visit https://clinicaltrials.gov and search company, condition, or treatment. For additional information on Expanded Access, please visit the U.S. Food and Drug Administration at: https://www.fda.gov/news-events/public-health-focus/expanded-access.
In line with the 21st Century Cures Act, Miracogen may revise this policy at any time.
ClinicalTrials.gov URL
EA Therapies for Single Patient