Huahui Health Ltd.

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.