Expanded Access Policy for Investigational Product
RemeGen Co., Ltd. is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen Co., Ltd.'s main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, RemeGen Co., Ltd. has laboratory research facilities and offices in Beijing, Shanghai and California.
Consistent with RemeGen’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, RemeGen will consider providing a requesting physician with pre-approval access to a specific RemeGen investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.
For an overview of our investigational products, please visit our pipeline chart. Alternatively, you may visit https://www.fda.gov/ and search for information on clinical trials sponsored by RemeGen.
Who might be eligible for expanded access to the investigational product?
The following criteria are typically required before RemeGen would consider patients eligible for expanded access to a RemeGen investigational product. All criteria are subject to local laws and regulations.
• The patient suffers from a life threatening or serious disease or condition, where there is an unmet medical need that cannot be met by existing products.
• The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
• The investigational product is under active development (a dose and regimen has been defined and the product is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
• The benefit-risk profile of the drug in the indication and the patient population is deemed, to date, to be positive which typically occurs when RemeGen has decided to seek marketing approval in at least one major market globally.
• RemeGen has decided to seek marketing approval in at least one major market globally.
• The expanded access use of the investigational product will not jeopardize the development of the drug (for instance, granting access to an investigational unapproved drug through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
• The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.
RemeGen cannot approve expanded access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
We commit to a careful and fair evaluation of each request by the appropriate medical experts at RemeGen within the boundaries of local laws and regulations. All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from RemeGen (or our agent) within 7 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with RemeGen.
For approved requests:
• RemeGen will provide the investigational product at no charge to the requestor for a duration and frequency determined by the company.
• The requestor is responsible for reporting any safety issues associated with the use of the investigational product to RemeGen and regulatory authorities as required.
• RemeGen is not accountable for securing local ethics committee approval for expanded use of its investigational product.
If you are a patient who feels that expanded access to an investigational medicine may benefit you, please consult with your physician. Physicians seeking help on behalf of their patients may contact RemeGen via email (firstname.lastname@example.org). Once RemeGen has received the request and required medical information, we will respond in no more than seven business days. If the request is approved by RemeGen, the country regulatory authority from where the request originated will need to grant final approval before RemeGen can ship the investigational medicine to the requesting physician.