Sph9788
Healthy Participants
Phase I
Recruiting
A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.
Feb 18, 2025
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Sph7485
Advanced Solid Tumor
Phase I
Recruiting
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
Jun 27, 2024
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Sph7854
Inflammatory Bowel Disease
Early Phase I
Recruiting
A Clinical Study of SPH7854 Granules in Healthy Subjects.
Jun 24, 2024
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B007, Cyclosporin Capsules
Primary Membranous Nephropathy
Phase II/III
Recruiting
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
Jun 17, 2024
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B007
Generalized Myasthenia Gravis
Phase II/III
Recruiting
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
Jun 03, 2024
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Paclitaxel, B013
Platinum-Resistant Recurrent Ovarian Cancer
Phase II
Recruiting
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
May 23, 2024
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Sph5030
Biliary Tract Or Colorectal Cancer With Her2-Positive/Mutated
Phase II
Recruiting
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
May 23, 2024
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B001
Neuromyelitis Optica Spectrum Disorders
Phase II/III
Recruiting
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
May 09, 2024
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T3011 High Dose, T3011 Middle Dose, T3011 Low Dose
Advanced Solid Tumors
Phase I/II
Recruiting
A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
Jan 09, 2024
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T3011
Advanced Melanoma
Phase I/II
Recruiting
A Clinical Study of T3011 in Subjects With Advanced Melanoma
Jan 09, 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 Shanghai Pharmaceuticals Holding Co Ltd Class H (SHPMF) have in its pipeline
SHPMF is currently developing the following drugs: Sph9788, Sph7485, Sph7854. These drug candidates are in various stages of clinical development as the company works toward FDA approval.