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Lee's Pharmaceutical Holdings Limited (HK:0950)
:0950
Inhaled Fentanyl Aerosol, Fentanyl Citrate Injection
Cancer
Phase I
Recruiting
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
Apr 16, 2025
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Socazolimab+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab
Cervical Cancer
Phase III
Recruiting
Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
Jun 03, 2024
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Au409
Advanced Hepatocellular Carcinoma
Phase I
Recruiting
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
Mar 11, 2024
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5-Aminolevulinic Acid
5-Aminolevulinic Acid, Fluorescence-Guided Resection
Phase III
Recruiting
Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)
Nov 27, 2023
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Istaroxime, 9% Saline (Ns)
Healthy
Phase I
Completed
Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
Jun 17, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Lee's Pharmaceutical Holdings Limited (0950) have in its pipeline
0950 is currently developing the following drugs: Inhaled Fentanyl Aerosol, Fentanyl Citrate Injection, Socazolimab+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab, Au409. These drug candidates are in various stages of clinical development as the company works toward FDA approval.