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HUTCHMED (HCM)
NASDAQ:HCM
Hmpl-306
Gliomas Harboring Idh1 And/Or Idh2 Mutations
Phase I
Recruiting
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
May 28, 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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Paclitaxel, Doxorubicin, Fruquintinib, Sintilimab
Advanced Endometrial Cancer
Phase III
Recruiting
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
Aug 21, 2024
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Hmpl-506
Hematological Malignancies
Phase I
Recruiting
A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
Apr 19, 2024
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Hmpl-306 Regimen, Salvage Chemotherapy Regimen
Acute Myeloid Leukemia
Phase III
Recruiting
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
Apr 16, 2024
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Surufatinib Combined With Camrelizumab, Nab-Paclitaxel, And Gemcitabine, Nab-Paclitaxel Plus Gemcitabine, Surufatinib With Nab-Paclitaxel, And Gemcitabine
Metastatic Pancreatic Cancer
Phase II/III
Recruiting
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
Mar 26, 2024
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Hmpl-523
Autoimmune Diseases, Primary Immune Thrombocytopenia, Hematologic Diseases, Immune System Diseases, Hemorrhage, Thrombotic Microangiopathies, Immune Thrombocytopenia, Pathologic Processes, Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia, Blood Platelet Disorder, Purpura, Thrombocytopenic, Purpura, Blood Coagulation Disorder, Hemorrhagic Disorders, Skin Manifestations, Itp - Immune Thrombocytopenia
Phase I
Withdrawn
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
Feb 13, 2024
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Tazemetostat, Hmpl-689
Relapsed/Refractory Lymphoma
Phase II
Completed
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
Dec 13, 2022
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Fruquintinib+Sintilimab, Axitinib / Everolimus, Fruquintinib
Advanced Renal Cell Carcinoma
Phase II/III
Active Not Recruiting
Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
Aug 16, 2022
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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-306, 100 Μci [14C] Hmpl-306, Hmpl-760 Planned Dose 1, R-Gemox, Hmpl-760 Planned Dose 2. These drug candidates are in various stages of clinical development as the company works toward FDA approval.