Last update 16 Nov 2024
Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen)
Last update 16 Nov 2024
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms SG-301, SG301, SG301 SC + [1] |
Target |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
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Related
6
Clinical Trials associated with Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen)A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
一项评价SG301 注射液联合泊马度胺和地塞米松对比安慰剂联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤有效性和安全性的随机、对照、双盲、多中心Ⅲ 期临床试验（第一阶段）
[Translation] A randomized, controlled, double-blind, multicenter Phase III clinical trial to evaluate the efficacy and safety of SG301 injection combined with pomalidomide and dexamethasone versus placebo combined with pomalidomide and dexamethasone in the treatment of relapsed/refractory multiple myeloma (Phase I)
A Randomized, Double-blind, Placebo-controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Characteristics of SG301 SC Injection in Single-dose Healthy Subjects and Multiple-dose Systemic Lupus Erythematosus (SLE) Subjects
100 Clinical Results associated with Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen)
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100 Translational Medicine associated with Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen)
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100 Patents (Medical) associated with Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen)
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100 Deals associated with Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen)
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Plasma cell myeloma refractory | Phase 3 | CN | 14 Jun 2024 | |
| Relapse multiple myeloma | Phase 3 | CN | 14 Jun 2024 | |
| Multiple Myeloma | Phase 3 | - | - | |
| Systemic Lupus Erythematosus | Phase 1 | CN | 10 Nov 2023 | |
| Hematologic Neoplasms | Phase 1 | US | 29 Jun 2022 | |
| Autoimmune Diseases | Phase 1 | - | - |
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