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 I clinical study titled ‘A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Malignant Tumors.’ The study aims to assess the safety and pharmacokinetic profile of inhaled fentanyl aerosol compared to intravenous fentanyl in cancer patients, which could offer a new pain management option.
The study tests two interventions: the experimental inhaled fentanyl aerosol and the active comparator, fentanyl citrate injection. Both are intended to manage pain in cancer patients, with the inhaled version potentially offering a more convenient administration method.
This interventional study uses a randomized, open-label, 2-cycle crossover design with no masking. The primary purpose is treatment, focusing on comparing the pharmacokinetics and safety of the two fentanyl delivery methods.
The study began on April 16, 2025, with primary completion and estimated completion dates yet to be announced. The most recent update was submitted on September 24, 2025, indicating ongoing recruitment and study progress.
The outcome of this study could significantly impact Lee’s Pharmaceutical’s stock performance by introducing a novel pain management solution, potentially enhancing market competitiveness. Investors should monitor this development closely, considering the competitive landscape in pain management solutions.
The study is ongoing, with further details available on the ClinicalTrials portal.
