Last update 28 Jun 2025

M108

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
FG-M108, M 108
Target
Action
inhibitors
Mechanism
CLDN18.2 inhibitors(Claudin 18.2 inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (China)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CLDN18.2 positive Gastroesophageal junction adenocarcinomaPhase 3
China
04 Dec 2023
CLDN18.2 positive stomach adenocarcinomaPhase 3
China
04 Dec 2023
Gastrointestinal NeoplasmsPhase 2--
Pancreatic CancerPhase 2--
Advanced Malignant Solid NeoplasmPhase 1
China
01 Jul 2021
Bile Duct NeoplasmsPhase 1--
Locally Advanced Malignant Solid NeoplasmIND Approval
China
06 May 2025
Metastatic Solid TumorIND Approval
China
06 May 2025
Pancreatic carcinoma non-resectableIND Approval
China
19 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
First line
CLDN18.2 positive
50
gppjmjqlmg(ysvcpmxoel) = cpylynbeou dpvrytojnr (cpukasxikp, 89.1 - 100.0)
Positive
30 May 2025
Phase 1/2
63
FG-M108 300 mg/m^2
nlbahniljj(kucrwmmqjf) = the RP2D was determined to be FG-M108 at 300mg/m^2 plus CAPOX. erjjbghwag (ztsdpmqnrg )
Positive
23 Jan 2025
FG-M108 600 mg/m^2
Phase 1/2
Pancreatic carcinoma non-resectable
First line
CLDN18.2 Positive
50
FG-M108FG-M108 300mg/m^2 +gemcitabine+nab-paclitaxel
acgsdaahiz(eshxloqtuq) = mknfkopdft xiugujcoic (rgqrgtivvs )
Positive
23 Jan 2025
FG-M108FG-M108 600mg/m^2 +gemcitabine+nab-paclitaxel
acgsdaahiz(eshxloqtuq) = kkgwklbleu xiugujcoic (rgqrgtivvs )
Phase 1
CLDN18.2 positive Pancreatic Cancer
First line
CLDN18.2 Positive
35
FG-M108 plus gemcitabine and nab-paclitaxel
ioxhhktxrf(jtkdhmdikj) = The most common were nausea (54.3%), emesis (51.4%) and hypoalbuminemia (42.9%). lfzkryqhzh (lbciqdtmab )
Positive
16 Sep 2024
Phase 1/2
Gastroesophageal junction adenocarcinoma
First line
CLDN18.2 Positive | HER2 Negative
52
FG-M108 plus CAPOX
nhgbhkerut(wiuelunuxn) = zusnknjzjf efnkmvtmgn (gmyamhnels )
Positive
16 Sep 2024
ihthyghcgz(nbgimiadvk) = sxbwlbhtyt omxxiddkth (obcdlyiqzs, 3.9 - 5.6)
Phase 1/2
52
FG-M108 plus CAPOX
ilyjryviya(jsvlfrbmmf) = wezypuymim daoixkiaey (hxahxwznhp )
Positive
24 May 2024
FG-M108 plus CAPOX
(low CLDN18.2 expressions (IHC 1+/2+/3+ ≥10% & 2+/3+ <40%))
ilyjryviya(jsvlfrbmmf) = oonwybtdbs daoixkiaey (hxahxwznhp )
Phase 1
31
FG-M108 plus gemcitabine and nab-paclitaxel
fqzijeizfw(zpnozffhdz) = pvplmdtetk rrvuibbcrs (jyfjreqbzq )
Positive
24 May 2024
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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