HAIXI PHARMA(02637.HK): HX9428 for nAMD Cleared by US‑FDA for Phase II Trial; Positive‑Control Phase II Study Initiated in China

NewTimeSpace News: Fujian Haixi Pharmaceuticals Co., Ltd. (02637.HK) released a voluntary announcement on 4 August 2026. The US Phase II clinical trial application for HX9428, the Company’s in‑house‑developed innovative drug for neovascular age‑related macular degeneration (nAMD, wet AMD), has been approved by the FDA. In parallel, the second randomized, positive‑control (head‑to‑head versus aflibercept) Phase II study (CTR20262884) has been formally initiated in China, planning to enrol 60 subjects.

HX9428 is an oral investigational innovative drug. It aims to overcome the limitation that current nAMD therapies mainly rely on intravitreal injection, by delivering a convenient administration regimen and improving patients’ long‑term treatment compliance. Phase I and Phase II dose‑expansion studies have been completed previously. The Company commented that the US Phase II clearance together with the launch of the Chinese controlled study mark important progress in global clinical development. HX9428 has not yet been approved for marketing; its safety and efficacy require further verification.

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