Last update 04 Apr 2026

LNF1904

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Recombinant Humanized Anti-CD19/CD3 Bispecific Antibody, LNF 1904, LNF-1904
+ [1]
Target
CD19 x CD3
Action
inhibitors, stimulants
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Therapeutic Areas
Immune System DiseasesHemic and Lymphatic DiseasesSkin and Musculoskeletal Diseases
Active Indication
B-Cell Malignant NeoplasmSystemic Lupus Erythematosus
Inactive Indication-
Originator Organization
Shandong New Time Pharmaceutical Co. Ltd.Shandong New Time Pharmaceutical Co. Ltd.
Active Organization
Shandong New Time Pharmaceutical Co. Ltd.Shandong New Time Pharmaceutical Co. Ltd.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-
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Related

2
Clinical Trials associated with LNF1904
CTR20222318
/ RecruitingPhase 1
评估 LNF1904 在复发/难治 B 细胞恶性肿瘤患者中的安全性、耐受性、初步有效性及药代动力学/药效学特征的 I 期临床研究
[Translation] Phase I study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic/pharmacodynamic characteristics of LNF1904 in patients with relapsed/refractory B-cell malignancies
CTR20244908
/ Not yet recruitingPhase 1
评估LNF1904 在复发/难治B 细胞恶性肿瘤患者中的安全性、耐受性、初步有效性及药代动力学/药效学特征的I 期临床研究
[Translation] Phase I clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic/pharmacodynamic characteristics of LNF1904 in patients with relapsed/refractory B-cell malignancies
100 Clinical Results associated with LNF1904
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100 Translational Medicine associated with LNF1904
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100 Patents (Medical) associated with LNF1904
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100 Deals associated with LNF1904
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
B-Cell Malignant NeoplasmPhase 1
China
Shandong New Time Pharmaceutical Co. Ltd.Shandong New Time Pharmaceutical Co. Ltd.
07 Feb 2023
Systemic Lupus ErythematosusIND Approval
China
Shandong New Time Pharmaceutical Co. Ltd.Shandong New Time Pharmaceutical Co. Ltd.
14 May 2025
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Clinical Result

Indication
Phase
Evaluation
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Deal

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Core Patent

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Clinical Trial

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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.
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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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