Hanmi Pharmaceutical Co., Ltd

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). LAPS GLP-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