Last update 15 Dec 2025

Culmerciclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
TQB 3616, TQB-3616, TQB3616
+ [1]
Action
inhibitors
Mechanism
CDK2 inhibitors(Cyclin-dependent kinase 2 inhibitors), CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC24H27FN8
InChIKeyLLFOBMRPWNABCB-UHFFFAOYSA-N
CAS Registry2004705-28-4

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancer
China
09 Dec 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
China
01 Jul 2022
Dedifferentiated LiposarcomaPhase 2
China
29 Jul 2022
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
China
18 Aug 2021
Non-Small Cell Lung CancerPhase 2
China
12 Aug 2021
Small Cell Lung CancerPhase 2
China
12 Aug 2021
Advanced breast cancerPhase 2
China
04 Feb 2021
ER-positive/HER2-negative Breast CancerPhase 1
China
29 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hormone receptor positive HER2 negative breast cancer
First line
HR Positive | HER2 Negative
432
mnylevtfkl | zdfsrykhns(lfsrftguny) = mvkjzlbtww hzmmplkpiv (tykcwylzgx )
Positive
17 Oct 2025
mnylevtfkl | zdfsrykhns(lfsrftguny) = llnrgoujye hzmmplkpiv (tykcwylzgx )
Phase 1
-
16
TQB3616 capsule under fasted conditions
risspbxyar(xgjmofzxkj) = llqkfkcowi okpnusikaz (ybndotwemh )
Positive
30 May 2025
Phase 3
-
ubdrucocck(asugfdodye) = isgiagqjyf mknwkgdtog (jblaotzefv )
Positive
27 Sep 2024
对照组
ubdrucocck(asugfdodye) = fbdbxmlsqg mknwkgdtog (jblaotzefv )
Phase 2
26
wvomaqiigm(gtjuogmunj) = heyzuwwlpd cysohlyuyt (lqykhsudfw, 40.0% ∼79.9%)
Positive
14 Sep 2024
Phase 2
HR-positive/HER2-low Breast Carcinoma
First line | Second line
HR Positive | HER2 Negative
111
(1st-, 2nd-line BC (100% Chinese) + 1st-line)
xsbhnudlpm(whqyukvlhn) = phlgzkizya rkclfrgdch (jfyncvmuwk )
Superior
01 Jan 2024
(1st-, 2nd-line BC (100% Chinese) + 2nd-line)
xsbhnudlpm(whqyukvlhn) = lwcixjrnct rkclfrgdch (jfyncvmuwk )
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Clinical Trial

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Approval

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Regulation

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