HUTCHMED (HCM)
NASDAQ:HCM
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Hmpl-523
Healthy
Phase I
Completed
Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets
Nov 26, 2025
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Hmpl-A251
Solid Tumors, Adult
Phase I/II
Recruiting
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
Nov 11, 2025
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Hmpl-523 Acetate Tablets
Healthy
Phase I
Completed
Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans
Sep 11, 2025
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100 Μci [14C] Hmpl-306
Mass Balance Study
Phase I
Completed
Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects
Oct 29, 2024
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Hmpl-760 Planned Dose 1, R-Gemox, Hmpl-760 Planned Dose 2
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Phase II
Active Not Recruiting
Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
Sep 08, 2024
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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 HUTCHMED (HCM) have in its pipeline
HCM is currently developing the following drugs: Hmpl-A580, Hmpl-523, Hmpl-A251. These drug candidates are in various stages of clinical development as the company works toward FDA approval.