August 18, 2026
Source: drugdu
46

Forwarding our company's announcement dated August 17, 2026:
The Board of Directors of our Company is pleased to announce that HX9428, a drug candidate molecule of our independently developed innovative drug project HXP056, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the development of a treatment for neovascular age - related macular degeneration ( nAMD, also known as wet age-related macular degeneration, wAMD) . This FTD designation will facilitate closer communication between our Company and the FDA regarding the clinical development of HX9428 and advance its global clinical development process.
HX9428 is a novel oral small molecule drug independently developed by Haixi New Drug, intended for the treatment of nAMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard treatment for nAMD. However, existing treatments require intravitreal injection into the eye, which may lead to long-term, repeated treatments, resulting in medical burdens, compliance challenges, and injection-related risks for patients. HX9428, administered orally, promises to provide nAMD patients with a more convenient treatment option than traditional injection therapies, helping to improve long-term treatment adherence and addressing current clinical treatment challenges.
Regarding Fast Track eligibility (FTD)
Fast Track designation (FTD) is an accelerated development and review pathway established by the FDA specifically for innovative drugs addressing serious diseases with unmet clinical needs. Drugs granted this designation enjoy several key policy supports: frequent and timely dedicated communication with the FDA throughout the entire clinical development and review process; eligibility for priority review and accelerated approval in subsequent applications; and the ability to utilize a rolling review model, eliminating the need to wait for a complete New Drug Application (NDA) and allowing for the submission of completed research modules in batches, thus shortening the overall review cycle.
The FDA requires two core criteria for Free Therapy (FTD) designation: first, the drug must target a serious disease; second, it must fill an unmet clinical need, meaning it must provide a treatment option not available with existing therapies or have potential clinical advantages over current standard treatments. The FDA's granting of FTD designation to HX9428 for the nAMD indication is an affirmation of its innovative drug design and potential clinical value. With the policy support for FTD designations, the global clinical development of HX9428 is expected to accelerate further.
Currently, the domestic R&D progress of HX9428 is progressing steadily, having successfully completed Phase I clinical trials. Phase II dose expansion studies and a second positive-control Phase II clinical trial are currently underway. Overseas R&D is also progressing simultaneously; HX9428 has received FDA approval to conduct Phase II clinical trials for nAMD in the United States. The company is fully committed to advancing its clinical development strategy in the US, aiming to benefit patients worldwide as soon as possible.
https://mp.weixin.qq.com/s?__biz=Mzg2NDU5NTI3Mg==&mid=2247484354&idx=1&sn=09abb56a9dd2eb8b528fda45408a3bdb&chksm=hczvean2wozhw4shpawmsd7pft2tt3p0d7q2clozkw6u81ds2x4xosom28i6fhb9pn86s4xtm550
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