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Single-Patient EA Policies/Criteria

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).

Available Therapies via Single-Patient EA

LAPS-Triple Agonist (also known as HM15211) is a long-acting Glucagon/GIP/GLP-1 triple agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker. The therapeutic indication is non-alcoholic steatohepatitis (NASH).

^LAPSGLP-2 Analog (also known as HM15912) is a long-acting glucagon-like peptide-2 (GLP-2) analogue linked to a human immunoglobulin G4 fragment crystallizable. The therapeutic indication is short bowel syndrome in the pediatric and adult populations.

Disease/Category-Specific EA Policies/Criteria

http://www.hanmipharm.com/ehanmi/handler/Rnd-FocusedPipelineA 

http://www.hanmipharm.com/ehanmi/handler/Rnd-FocusedPipelineB

Single-Patient EA Policies/Criteria

Policy Statements
Any use of investigational products outside a clinical study in a country must be in accordance with local laws and regulations governing such programs.

In general, where permitted by local regulation, investigational products supplied via Expanded Access may no longer be provided when it becomes available via the local healthcare system.

A. Patient Eligibility Criteria

The U.S. FDA advises that Expanded Access may be appropriate when patients must meet the following criteria:

Suffer from a serious or immediately life-threatening disease or condition.
Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative therapy is available or exists to treat the disease or condition.
Are ineligible, impossible, or not feasible for enrollment or participation in any clinical trial of investigational products.
The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.

B. Investigational Products Criteria

In addition to the patient eligibility requirements, the investigational product must meet the following criteria:

The investigational product is under investigation in one or more clinical studies.
There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population.
The provision of the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

For more information about Expanded Access in the U.S., please visit the U.S. FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access

Conclusion representation

Generally, Huahui does not provide the investigational products to patients until there is sufficient data on their safety and efficacy, enabling patients and physicians to make informed decisions about the potential risks and benefits of using these investigational products outside of a clinical trial setting. Therefore, after careful consideration, Huahui is not currently offering Expanded Access to the investigational product.

In the future, Huahui may reassess Expanded Access for each of its investigational products with further progress in clinical trials and more data supporting their safety and efficacy.