CDEK
← All drugs Report issue

toripalimab

Trade name: LOQTORZ

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Oct 27, 2023

Clinical trial activity

443 trials · 127 clinical orgs · 1 marketing orgs

Phase 1
107
Phase 2
367
Phase 3
53
Phase 4
3

Earliest trial started Mar 1, 2016 (NCT02857166)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. May 18, 2020

    Orphan Drug Designation

  2. Oct 27, 2023

    Coherus BioSciences — Earliest FDA Approval

  3. Oct 27, 2023

    Coherus BioSciences — Marketing Organization

  4. Oct 27, 2023

    Coherus BioSciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughOct 27, 2023

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • js001
  • js-001

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07290621Phase 2Feb 28, 2026University of Chicago
NCT07281716Phase 1/Phase 2 (Phase 2)Dec 31, 2025Cantargia AB, Coherus Oncology, Inc., Icahn School of Medicine at Mount Sinai
NCT07281976Phase 1/Phase 2 (Phase 2)Dec 31, 2025Nanjing Leads Biolabs Co.,Ltd, Nanjing Medical University
NCT07309276Phase 2Dec 30, 2025Shanghai Junshi Bioscience Co.,Ltd.
NCT07272291Phase 2Dec 25, 2025Tianjin Medical University
NCT07286942Phase 2Dec 18, 2025Jiangsu Cancer Institute & Hospital
NCT07246330Phase 3Dec 15, 2025Tianjin Medical University
NCT07277322Phase 1/Phase 2 (Phase 2)Dec 15, 2025Coherus Oncology, Inc., Icahn School of Medicine at Mount Sinai
NCT07279597Phase 2Dec 10, 2025Huazhong University of Science and Technology
NCT07307456Phase 2Dec 8, 2025Changhai Hospital
NCT07245901Phase 1/Phase 2 (Phase 2)Dec 5, 2025Sun Yat-Sen University
NCT07244874Phase 2Dec 1, 2025People's Liberation Army of China, Tianjin Medical University
NCT07201675Phase 2Dec 1, 2025Shandong University
NCT07209189Phase 2Dec 1, 2025Coherus Oncology, Inc., Johns Hopkins University
NCT07172412Phase 2Nov 30, 2025Tianjin Medical University
NCT07154069Phase 3Nov 13, 2025Sun Yat-Sen University
NCT07258979Phase 1/Phase 2 (Phase 2)Nov 5, 2025Suzhou Medilink Therapeutics Ltd.
NCT07189793Phase 2Oct 31, 2025Wenzhou Medical University
NCT07040644Phase 2Sep 30, 2025Sun Yat-Sen University
NCT07111832Phase 3Sep 30, 2025Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Showing 20 of 443 trials
Page 1 / 23

Organizations

Research & Development (127)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Sun Yat-Sen UniversityAcademic/Hospital898042016
Shanghai Junshi Bioscience Co.,Ltd.For profit654242016
Chinese Academy of Medical SciencesAcademic/Hospital543652016
Fudan UniversityAcademic/Hospital403342018
Jiao Tong UniversityAcademic/Hospital252142019
Huazhong University of Science and TechnologyAcademic/Hospital211532019
Peking UniversityAcademic/Hospital191142016
Tianjin Medical UniversityAcademic/Hospital191742019
Zhejiang UniversityAcademic/Hospital181542019
Guangzhou Medical UniversityAcademic/Hospital10522019
Sichuan UniversityAcademic/Hospital10932019
Southern Medical UniversityAcademic/Hospital10732020
Central South UniversityAcademic/Hospital9532019
People's Liberation Army of ChinaGovernment9642016
Fujian Medical UniversityAcademic/Hospital8422020
Henan Medical UniversityAcademic/Hospital8532019
RemeGenFor profit8822022
China Medical UniversityAcademic/Hospital7642020
LaNova Medicines LimitedFor profit7712022
Xiamen UniversityAcademic/Hospital7132020
127 organizations
Page 1 / 7

Marketing (2)

OrganizationOrg typeRelationshipDate
Coherus BioSciencesFor profitMKTGOct 27, 2023
Coherus BioSciencesFor profitNDAOct 27, 2023