Shire BioScience (Shanghai) Co., Ltd.

To evaluate the efficacy and safety of lanariumab and icatibant in Chinese patients who received at least one dose of lanariumab or icatibant in real-world clinical practice.

Primary objective The primary objective of this study is to evaluate the safety of repeated subcutaneous administration of lanarumab in Chinese HAE subjects. Secondary objectives The secondary objectives of this study are: To evaluate the PK of repeated subcutaneous administration of lanarumab in Chinese HAE subjects. To evaluate the PD of repeated subcutaneous administration of lanarumab in Chinese HAE subjects. To evaluate the efficacy of repeated subcutaneous administration of lanarumab in Chinese HAE subjects. To evaluate the immunogenicity of repeated subcutaneous administration of lanarumab and its effect on the PK, PD, efficacy and safety of lanarumab.

Primary objective: To evaluate the safety of Ripuga in Chinese Fabry disease naïve subjects by evaluating the incidence of treatment-emergent serious adverse events (TEAEs) throughout the study. Secondary objectives: 1. To evaluate other safety parameters of Ripuga; 2. To evaluate the efficacy of Ripuga on renal function parameters (estimated glomerular filtration rate [eGFR]); 1) To evaluate the efficacy of Ripuga on other renal function variables, pain, and pharmacodynamic (PD) markers (plasma lyso-Gb3); 2) To evaluate hearing changes in subjects aged <18 years; 3) To evaluate the pharmacokinetics (PK) of Ripuga in Chinese Fabry disease naïve subjects.