Lee’s Pharmaceutical Holdings Limited ((HK:0950)) announced an update on their ongoing clinical study.
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Lee’s Pharmaceutical Holdings Limited is conducting a Phase IV clinical study titled ‘A Prospective, Open, Single-arm, Multi-center Phase IV Clinical Study of Inhaled Nitric Oxide Combined With Ventilatory Support for the Treatment of Neonatal (Gestational Age ≥34 Weeks) Hypoxic Respiratory Failure With Pulmonary Hypertension.’ The study aims to evaluate the safety of INOmax, a treatment for newborns suffering from hypoxic respiratory failure with pulmonary hypertension, highlighting its potential significance in neonatal care.
The intervention being tested is inhaled nitric oxide (NO), administered via the INOmax DSIR Plus delivery system. This treatment is designed to improve oxygenation in newborns, with dosing adjustments based on arterial oxygenation levels.
The study is observational with a cohort model and a prospective time perspective. It is open-label and single-arm, focusing on safety as the primary purpose, with no masking involved.
The study began on July 23, 2025, with the latest update on July 29, 2025. These dates are crucial as they mark the study’s progress and the availability of updated information for stakeholders.
This clinical study update could influence Lee’s Pharmaceutical Holdings Limited’s stock performance and investor sentiment, as successful results may enhance the company’s market position in neonatal treatments. Investors should also consider the competitive landscape and potential advancements in similar treatments by other industry players.
The study is currently recruiting, with further details available on the ClinicalTrials portal.