Effective Date: [August 21, 2026]
About Haixi Pharma and HX9428
Fujian Haixi Pharmaceuticals Co., Ltd. is committed to the discovery and development of innovative medicines that address significant unmet medical needs and have the potential to improve treatment outcomes and quality of life for patients.
HX9428 is an investigational oral therapy being developed by Haixi Pharma for the treatment of neovascular age-related macular degeneration (nAMD). HX9428 is currently under clinical development. Its safety and efficacy have not been established by regulatory authorities, and HX9428 has not been approved for commercial use.
Our Approach to Expanded Access
Haixi Pharma recognizes the importance of access to investigational therapies for patients with serious or vision-threatening diseases and understands that patients and their physicians may have an interest in receiving HX9428 outside of a clinical study.
At the current stage of development, however, Haixi Pharma believes that participation in appropriately designed and monitored clinical trials is the most appropriate way for patients to access HX9428. Clinical trials provide patients with access to the investigational therapy under defined treatment conditions and enable the systematic collection of safety, pharmacokinetic, and efficacy information that is essential to the continued development of HX9428.
Accordingly, Haixi Pharma does not currently provide an Expanded Access Program for HX9428 and is not accepting requests for Expanded Access to HX9428 at this time.
This policy applies to requests for access to HX9428 outside of Haixi Pharma-sponsored or otherwise authorized clinical studies.
Clinical Trial Access
Patients and physicians who are interested in HX9428 are encouraged to consider participation in an ongoing clinical study, where appropriate and where the patient meets the applicable eligibility criteria.
Information regarding clinical studies of HX9428 may be available through applicable clinical trial registries and other public sources.
Future Review of this Policy
Haixi Pharma will continue to monitor the clinical development of HX9428 and the evolving regulatory environment. As additional clinical and safety information becomes available, Haixi Pharma may reassess its approach to Expanded Access.
Any future decision to establish an Expanded Access Program will be subject to applicable laws and regulations, regulatory requirements, the availability of sufficient clinical and safety information, product supply, and the potential impact on the ongoing development of HX9428.
Nothing in this policy should be interpreted as a guarantee or commitment by Haixi Pharma to provide HX9428 through Expanded Access in the future.
Haixi Pharma remains committed to advancing the development of HX9428 responsibly and efficiently, with the ultimate goal of bringing a potentially meaningful new treatment option to patients with nAMD.
Last Updated: [August 21, 2026]
