Anti-RANKL Monoclonal Antibody — Competitive Intelligence Brief

Anti-RANKL Monoclonal Antibody (Anti-RANKL Monoclonal Antibody) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Monoclonal antibody. Area: Osteoporosis.

phase 1 Monoclonal antibody RANKL Osteoporosis Biologic

Target snapshot

Anti-RANKL Monoclonal Antibody (Anti-RANKL Monoclonal Antibody) — Shanghai JMT-Bio Inc.. Inhibits RANKL

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Anti-RANKL Monoclonal Antibody TARGET	Anti-RANKL Monoclonal Antibody	Shanghai JMT-Bio Inc.	phase 1	Monoclonal antibody	RANKL
Denosumab (Prolia)	Denosumab (Prolia)	Prince of Wales Hospital, Shatin, Hong Kong	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (receptor activator of nuclear factor kappa-B ligand)
Denosumab Prefilled Syringe [Prolia]	Denosumab Prefilled Syringe [Prolia]	Seoul National University Bundang Hospital	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Placebo to Denosumab	Placebo to Denosumab	Amgen	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
DMAB Discontinuation and Switching	DMAB Discontinuation and Switching	University of Alabama at Birmingham	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
BONCRESA	DENOSUMAB-MOBZ	AMNEAL PHARMS LLC	marketed	RANK Ligand Inhibitor [EPC]	RANKL
Denosumab De-escalation	Denosumab De-escalation	National Taiwan University Hospital	marketed	RANKL inhibitor monoclonal antibody de-escalation strategy	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Monoclonal antibody class)

1. Pfizer · 7 drugs in this class
2. argenx · 7 drugs in this class
3. Johnson & Johnson · 2 drugs in this class
4. German CLL Study Group · 2 drugs in this class
5. Amgen · 2 drugs in this class
6. Hoffmann-La Roche · 2 drugs in this class
7. Brii Biosciences Limited · 2 drugs in this class
8. Alexion Pharmaceuticals, Inc. · 2 drugs in this class
9. Biotest · 2 drugs in this class
10. Fondazione Italiana Linfomi - ETS · 2 drugs in this class