Dizal Pharmaceuticals

Single-Patient EA Policies/Criteria Sunvozertinib (DZD9008) At Dizal we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. One of the Dizal's lead products, sunvozertinib, is an oral EGFR tyrosine kinase inhibitor (TKI). It is currently being investigated as a single agent in phase 2 and phase 3 clinical trials for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR Exon20ins mutation. We are enrolling and conducting clinical trials aiming at gaining regulatory approval to make sunvozertinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access sunvozertinib at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov. Dizal understands the interest of patients in accessing drugs, such as sunvozertinib, outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. Because sunvozertinib is an investigational drug, and its efficacy and safety are still under evaluation, sunvozertinib can only be administered in accordance with local investigational drug requirement by an experienced physician. Dizal now offers Individual Patient Access for its investigational drug sunvozertinib for the treatment of adult patients with Advanced Non-Small Cell Lung Cancer (NSCLC), with EGFR or HER2 mutation, at the sites participating in ongoing clinical trials of sunvozertinib. Individual patients at these sites may be able to access sunvozertinib if they are ineligible for the available standard of care and are recommended by the treating physician to the Individual Patient Access Program. In order to meet FDA requirements, Dizal will provide a Letter of Authorization (LOA), referencing the content in Dizal’s US IND, to each treating physician to support their written requests (IND) for individual patient use. This same principle may be applied to countries with IND/CTA of sunvozertinib opened to fulfill the local regulatory requirements. Golidocitinib (DZD4205, AZD4205) At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. One of Dizal's lead products, golidocitinib, is an oral, potent, highly selective Janus kinase 1 (JAK1) inhibitor. It is currently being investigated as a single agent in a phase 2 clinical trial for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). We are conducting clinical trials aiming at gaining regulatory approval to make golidocitinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access golidocitinib at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov. Dizal understands the interest of patients in accessing drugs, such as golidocitinib, outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. Because golidocitinib is an investigational drug, and its efficacy and safety are still under evaluation, golidocitinib can only be administered in accordance with local investigational drug requirements by an experienced physician. Dizal now offers Individual Patient Access to the investigational drug golidocitinib for the treatment of adult patients with r/r PTCL at the sites participating in ongoing clinical trials of golidocitinib. Individual patients at these sites may be able to access golidocitinib if they are ineligible for the available standard of care and are recommended by the treating physician to the Individual Patient Access Program. In order to meet the FDA's requirements, Dizal will provide a Letter of Authorization (LOA), referencing the content in Dizal's US IND, to each treating physician to support their written requests (IND) for individual patient use. The same principle may be applied to countries with IND/CTA of golidocitinib opened to fulfill the local regulatory requirements. Available Therapies via Single-Patient EA DZD9008 (INN name: sunvozertinib): Non-Small Cell Lung Cancer (NSCLC) patients with EGFR Exon20ins mutation DZD4205 (AZD4205, INN name: golidocitinib): Relapsed/refractory peripheral T-cell lymphoma (r/r PTCL)