Pacific Meinuoke Biopharmaceutical

Expanded Access Policy



 

Access to Investigational Medicines
At Jiangsu Pacific Meinuoke Biopharceuticals (PMBP), we commit to bringing new, innovative therapies to patients by conducting rigorous clinical trials and obtaining marketing approval by the FDA and other regulatory authorities.
For people seeking access to investigational medicines before they are approved by a regulatory authority, participation in clinical trials is the first and most preferable route. PMBP conducts clinical trials to study the investigational medicines in patients in which the studies are designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients.
In certain circumstances, however, when patients have exhausted all available medical options and participation in clinical trials is not an option, PMBP may provide physician-requested expanded access (also known as compassionate use) to its investigational products to patients who cannot join an active clinical trial of the investigational product providing the criteria below are met.

Criteria for Considering Requests for Expanded Access
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative treatment for the disease or condition.
- Sufficient clinical evidence of safety and effectiveness in the indication has been established and the potential benefit justifies the potential risks. In this context, the investigational product would have generally at least completed Phase II clinical studies.
- The product is under active development in the indication and expanded access will not interfere with the development of the product.
- The company has an adequate supply of the investigational medicine for Expanded Access Program.
- There is a regulatory mechanism in the country or region to support expanded access.
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.
PMBP's Policy with Regards to the Expanded Access
Individual patient expanded access is managed by the patient's physician. We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial.
At this point of time, PMBP believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. We do not currently provide our investigational drugs for use through expanded access. Should the circumstance permits change to our expanded assess policy, updates with the instruction for requesting the expanded access will be posted to this website. In the mean time, questions with regards to the expanded access to Meplazumab for Injection may still be sent to us. PMBP will endeavor to acknowledge receipt of any expanded access questions within 10 business days of receipt.
No requests for the expanded access to Meplazumab for Injection can be reviewed at this moment. After the expanded access becomes available, the official requests will be reviewed and evaluated. The request for access to a PMBP investigational medicine will only be considered if the patient's treating physician is committed to, and supportive of, the requested treatment.
Contact information
If you are interested in learning more about PMBP’s expanded access program, please contact expandedaccess@pmbp.cn

Content current as of: Feb 25th, 2020