HAIXI PHARMA (02637.HK): Oral Retinal Disease Drug HX9428 Files Phase IIa IND for Diabetic Macular Edema; Phase I Data in nAMD Disclosed

NewTimeSpace News: On 2 September 2026, Fujian Haixi Pharmaceuticals Co., Ltd. (stock code: 02637.HK) announced that HX9428, a candidate molecule under its self-developed innovative drug program HXP056, submitted a Phase IIa investigational new drug (IND) application for diabetic macular edema (DME) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) on 31 August 2026, making DME the second indication being advanced for HX9428.
The Phase I dose-escalation study for the first indication, neovascular age-related macular degeneration (nAMD, also known as wet AMD), has been fully completed, enrolling 15 patients across five dose levels of 5-40 mg/QD. Of these, 13 patients (including 3 treatment-naive patients and 10 previously treated with anti-VEGF therapy) completed the planned 24 weeks of dosing without any additional intravitreal anti-VEGF injections; best-corrected visual acuity (BCVA) improved by more than 5 letters on average across the overall population, with the 3 treatment-naive patients improving by an average of 12 letters. Interim Phase I data as of February 2026 were published in the abstract of the 2026 American Academy of Ophthalmology (AAO) meeting, and HX9428 has received Fast Track Designation (FTD) from the US FDA, with Phase II studies in nAMD ongoing concurrently in China and the United States.
HX9428 is a novel oral small-molecule drug developed in-house for vascular retinal diseases including nAMD, DME and RVO. Current anti-VEGF therapy requires intravitreal injection, and oral administration is expected to offer patients a more convenient alternative. The company listed on the Main Board of the Hong Kong Stock Exchange in October 2025.

View announcement.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.