HAIXI PHARMA (02637) shares jumped more than 14% in early trading, before settling to a gain of 5.42% at HK$196.40, with a trading volume of HK$21.28 million.

The company announced that its self-developed innovative drug candidate, HX9428, for the treatment of neovascular age-related macular degeneration (nAMD), has received approval from the US Food and Drug Administration (FDA) to commence a Phase 2 clinical trial in the United States. Simultaneously, Haixi Pharma has initiated a second Phase 2 trial in China, using a positive control (Aflibercept), planning to enroll 60 patients.

Public information indicates that HX9428 is an oral innovative drug candidate designed to overcome the current reliance on intravitreal injections for nAMD treatment, offering a more convenient dosing regimen to improve long-term patient compliance. Prior studies have completed Phase 1 and Phase 2 dose expansion stages.

The company stated that the US Phase 2 approval and the initiation of the controlled study in China represent significant progress in global clinical development. HX9428 has not yet been approved for marketing, and its safety and efficacy require further validation.