Expanded Access

Hutchison China MediTech Limited, is committed to developing targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Our Innovation Platform, known as Hutchison MediPharma Limited (“Hutchison MediPharma”), has been the main driver of creating and developing our portfolio of drug candidates since 2002.

Hutchison MediPharma

Expanded Access Policy

Hutchison MediPharma is committed to making investigational products available to seriously ill patients or patients with a life threatening disease or illness who have exhausted all available treatment options. Our goal is to encourage clinical trial participation in order to further the science behind patient care. Clinical trials are research studies conducted to determine if an investigational medicine is safe and effective for patients. However, in the event clinical trial participation is not available or feasible, when patients do not qualify for clinical trials and have exhausted all available medical options, Hutchison MediPharma may consider providing an investigational agent outside of a clinical trial, or before it is approved by regulators as part of an individual or group based expanded access program.

Who is Eligible

A treating physician, who is able to comply with the requirements that are stated in this policy, may request information about how to apply for access to Hutchison MediPharma investigational agents by contacting the company.

This policy describes Hutchison MediPharma’s corporate policy regarding expanded access programs on how physicians may be able to access our investigational agents on behalf of a patient in medical need if that patient does not qualify for participation in available clinical trials and otherwise meets the criteria of this policy.

This policy applies to provision of access to a Hutchison MediPharma investigational agent that is not approved for any purpose in the country in which the patient and the physician are resident. It also includes the time period between regulatory approval of an investigational agent and its commercial availability in such country.

Hutchison MediPharma is committed to evaluate all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician. Hutchison MediPharma may require more detailed information in order to fully evaluate the appropriateness of request. The requesting physician must:

    • be properly licensed and fully qualified to administer the product
    • agree to obtain appropriate regulatory and ethics committee approvals
    • comply with regulatory obligations including obtaining patient consent, patient monitoring and safety reporting

Each request will be given careful considerations on a case by case basis by Hutchison MediPharma whose decisions are final.

How to request Expanded Access

Physicians should provide name, affiliation, contact detail, investigational agent and brief description when seeking expanded access for patient. Requests can be submitted via email to: ExpandedAccess@hmplglobal.com. We will use our best efforts to acknowledge each submitted request within 3 business days from receipt.

 

Hutchison MediPharma Approach to Expanded Access

The following criteria must be met in order for a patient to be considered eligible for Expanded Access:

    • The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate available treatment options or no treatment options are available
    • The patient is not eligible to participate in a clinical trial
    • The investigational agent is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition
    • A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational agent available
    • Investigational agent availability as part of an expanded access program will not negatively impact or interfere with or compromise the clinical development of the agent
    • The patients meet any additional medical criteria established by Hutchison MediPharma as required to support patient’s entry into this program
    • A determination by Hutchison MediPharma that an adequate supply of the investigational agent is available

Any use of Hutchison MediPharma investigational agent in an expanded access program must be done in accordance with local laws and regulations governing such program, and in accordance with Hutchison MediPharma policies and procedures.

Unless prohibited by local regulations, the expanded access program will be terminated by Hutchison MediPharma once the regulatory agency approves the investigational agent for commercial use.

Hutchison MediPharma may revise this policy at any time.