Hanmi is biopharmaceutical company developing innovative medicine where unmet medical needs exist.
Whenever possible, an investigational product should be used as part of a clinical trial. However, if patient enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials) or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational product.
The best way for patients to be treated with Investigational Products is through participation in a clinical trial, please visit www.clinicaltrials.gov for more information about the trial and trial sites.
This policy outlines the access to Hanmi’s investigational products that are not approved yet in the country.
Hanmi makes best effort for patients with a life-threatening or serious disease to gain access to an investigational product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
In general, treating physicians who have experience and knowledge of the investigational product may apply for access for their patients by contacting EA@hanmi.co.kr
Requests by treating physicians for expanded access are generally reviewed by Hanmi within 10 working days and Hanmi’s response is provided directly to treating physicians. Patients or non-health care professionals should contact their treating physicians if they want access to Hanmi’s investigational products.
Any use of Hanmi’s investigational products outside clinical trials should be made in accordance with local regulations and guidelines as well as Hanmi’s procedures and policies.
Hanmi will not grant access to Hanmi’s investigational products if the expanded access will interfere with the company’s ability to complete clinical trials as planned or will delay the drug development program.
Hanmi will grant access to Hanmi’s investigational products when there is an adequate supply of the investigational products to meet the needs of the expanded access without impairing clinical trials for drug development.
Hanmi will provide investigational product with 3 months’ treatment supply per case. In case treating physician judges that it is beneficial for patients to continue Hanmi’s investigational products, new apply should be made.
In general, where permitted by local regulation, an investigational product provided via expanded access according to local regulations and guidelines will no longer be provided by Hanmi once it becomes available on the market.
Hanmi may decide not to provide an investigational product under this policy if Hanmi decides to stop the drug development or not to launch in the concerned country(ies).
Treating Physicians who are receiving the investigational product via expanded access should be properly licensed and qualified to handle the investigational products.
The treating physicians should have experience and knowledge with the investigational product and should comply with the followings.
Hanmi will periodically re-evaluate the potential for expanded access. Hanmi reserves the right to amend this policy at any time without prior notice and access to Hanmi’s investigational product is not always guaranteed.