Chigenovo’s Expanded Access Policy

Chigenovo Co., Ltd.（Chigenovo）is a biotechnology company committed to develop innovative therapies for hereditary eye diseases by conducting rigorous clinical trials and obtaining marketing approval by the U.S. Food and Drug Administration (FDA), China National Medical Products Administration (NMPA) and other regulatory authorities. One of the Chigenovo's lead investigational products, ZYS101e is a gene replacement therapy for patients with CYP4V2 gene mutations administered by subretinal injection. A phase 3 clinical trial of ZVS101e in patients with Bietti's Crystalline Corneoretinal Dystrophy (BCD) is planned to be initiated in the second half of 2024 in China.

Expanded access (or referred to as“compassionate use”) is used to describe treatment with an investigational product for a patient with a serious or immediately life-threatening illness when there are no comparable or satisfactory alternative treatments available and the patient is ineligible or unable to participate in a clinical trial. For more information about expanded access, please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.

We believe participation in our clinical trial is the most appropriate way to access ZVS101e at this stage of development. Information about our phase 3 clinical trial, including eligibility criteria and locations, will be available at clinicaltrials.gov.

Given that the efficacy and safety of the investigational product have not yet been confirmed, Chigenovo currently does not offer any Expanded Access Programs for ZVS101e outside of our clinical studies. Chigenovo acknowledges the need for Expanded Access Program and will reassess our policy based on data from ongoing and future clinical trials.

If you have any additional questions for Expanded Access Program, please feel free to contact Chigenovo by ChigenovoCT@chinagene.cc.