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InnoCare Pharma Ltd. (HK:9969)
:9969
Rituximab, Orelabrutinib, Bendamustine Injection
Mantle Cell Lymphoma
Phase III
Recruiting
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Apr 09, 2024
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Icp-248, Obinutuzumab (G), Rituximab (R)
Mature B-Cell Malignancies
Phase I
Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies
Apr 02, 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 InnoCare Pharma Ltd. (9969) have in its pipeline
9969 is currently developing the following drugs: Rituximab, Orelabrutinib, Bendamustine Injection, Icp-248, Obinutuzumab (G), Rituximab (R). These drug candidates are in various stages of clinical development as the company works toward FDA approval.