Last update 04 Nov 2024
Omalizumab biosimilar (CSPC)
Last update 04 Nov 2024
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody |
Synonyms Omalizumab Biosimilar (Synermore Biologics (Suzhou) Co., Ltd.), Recombinant anti-IgE monoclonal antibody(CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.), 奥马珠单抗生物类似药（Synermore Biologics (Suzhou) Co., Ltd.） + [6] |
Target |
Mechanism IgE inhibitors(Immunoglobulin E inhibitors) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date CN (26 Sep 2024), |
Regulation- |
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Gene Sequence
Sequence Code 81670L
The sequence is quoted from: *****
Sequence Code 143601H
The sequence is quoted from: *****
Related
5
Clinical Trials associated with Omalizumab biosimilar (CSPC)A Phase 3, Randomized, Double-blind, Parallel group, Active Controlled Study to Compare the Efficacy and Safety of SYN008 to Xolair® in Adult Patients with Chronic Spontaneous Urticaria and Inadequate Response to H1 Antihistamine Treatment
一项 SYN008 与注射用奥马珠单抗（ Xolair）治疗难治性慢性自发性荨麻疹患者的随机、双盲、平行、阳性对照的多中心等效性临床试验
[Translation] A randomized, double-blind, parallel, positive-controlled, multicenter equivalence trial of SYN008 versus omalizumab injection (Xolair) in patients with refractory chronic spontaneous urticaria
A Multicenter Randomized, Double-blind, Parallel, Positive-controlled Phase III Clinical Trial to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria
100 Clinical Results associated with Omalizumab biosimilar (CSPC)
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100 Translational Medicine associated with Omalizumab biosimilar (CSPC)
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100 Patents (Medical) associated with Omalizumab biosimilar (CSPC)
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27
Literatures (Medical) associated with Omalizumab biosimilar (CSPC)25 Apr 2023International journal of molecular sciences
A Novel Rabbit Anti-Myoglobin Monoclonal Antibody's Potential Application in Rhabdomyolysis Associated Acute Kidney Injury.
Article
Author: Han, Lu ; Gong, Yanhua ; Qiao, Ou ; Wang, Xinyue ; Li, Ning
Myoglobin (Mb) is the main constituent of vertebrate skeletal muscle and myocardium and plays an essential role in oxygen binding, storage, transport, and earliest disease diagnosis. This study focuses on preparing the novel recombinant rabbit anti-Mb monoclonal antibody and applying it to a diagnosis of Mb deposition in rhabdomyolysis-associated acute kidney injury (RM-AKI). The full-length coding sequence of rat Mb was cloned and expressed, and the high-quality and titer rabbit anti-Mb polyclonal antibodies were produced by the immunogen His-Mb fusion protein. A new hybridoma cell was obtained by hybridoma screening technology. With the help of DNA sequencing and a molecular clonal, anti-Mb monoclonal antibody heavy and light chains expression plasmid was constructed. Finally, the recombinant rabbit anti-Mb monoclonal antibody with extraordinarily high affinity (KD = 1.21 pM) was obtained. Meanwhile, it had broad species reactivity (mouse, rat, human, and horse) and good tissue specificity (skeletal muscle and myocardium). It also had a very good performance in western blotting, immunohistochemistry, and immunofluorescence assay to detect the Mb level in the kidney, myocardium, and skeletal muscle of RM-AKI. This study will be significantly helpful for Mb-associated disease diagnosis, and pathogenesis exploration, and further may act as a neutralizing antibody for disease treatment.
06 Feb 2023Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]
[A real world study of anti-IgE monoclonal antibody in the treatment of allergic united airway disease].
Article
Author: Cong, T C ; Wang, Q G ; Sui, H J ; Huang, J J ; Hu, Y ; Zhen, Z
Objective: To investigate the clinical efficacy and safety of anti-IgE monoclonal antibody (omazumab) in the treatment of allergic united airway disease (UAD) in the real-wold. Methods: Retrospective cohort study summarizes the case data of patients with allergic united airway disease who were treated with anti IgE monoclonal antibody (omalizumab) for more than 16 weeks from March 1, 2018 to June 30, 2022 in the Peking University First Hospital.The allergic UAD is defined as allergic asthma combined with allergic rhinitis (AA+AR) or allergic asthma combined with chronic sinusitis with nasal polyps (AA+CRSwNP) or allergic asthma combined with allergic rhinitis and nasal polyps (AA+AR+CRSwNP). The control of asthma was evaluated by asthma control test (ACT), lung function test and fractional exhaled nitric oxide (FeNO). The AR was assessed by total nasal symptom score (TNSS). The CRSwNP was evaluated by nasal visual analogue scale (n-VAS), sino-nasal outcome test-22 (SNOT-22), nasal polyps score (TPS) and Lund-Mackay sinus CT grading system. The global evaluation of omalizumab for the treatment of allergic UADwas performed by Global Evaluation of Treatment Effectiveness(GETE).The drug-related side effects were also recorded. Matched t test and Wilcoxon signed-rank test were used to compare the score changes of IgE monoclonal antibody (omazumab) before and after treatment, and multivariate logistic regression analysis was used to determine the influencing factors of IgE monoclonal antibody (omazumab) response. Results: A total of 117 patients with UAD were enrolled, ranging in age from 19 to 77 years; The median age of patients was 48.7 years; Among them, 60 were male, ranging from 19 to 77 years old, with a median age of 49.9 years; There were 57 females, ranging from 19 to 68 years old, with a median age of 47.2 years. There were 32 cases in AA+AR subgroup, 59 cases in AA+CRSwNP subgroup, and 26 cases in AA+AR+CRSwNP subgroup. The total serum IgE level was 190.5 (103.8,391.3) IU/ml. The treatment course of anti IgE monoclonal antibody was 24 (16, 32) weeks. Compared with pre-treatment, omalizumab increased ACT from 20.0 (19.5,22.0) to 24.0 (23.0,25.0) (Z=-8.537, P<0.001), increased pre-bronchodilator FEV1 from 90.2 (74.8,103.0)% predicted value to 95.4 (83.2,106.0)% predicted value (Z=-5.315,P<0.001), increased FEV1/FVC from 80.20 (66.83,88.38)% to 82.72 (71.26,92.25)% (Z=-4.483,P<0.001), decreased FeNO from(49.1±24.8) ppb to (32.8±24.4) ppb (t=5.235, P<0.001), decreased TNSS from (6.5±2.6)to (2.4±1.9) (t=14.171, P<0.001), decreased n-VAS from (6.8±1.2) to (3.4±2.0)(t=14.448, P<0.001), decreased SNOT-22 from (40.0±7.9) to (21.3±10.2)(t=15.360, P<0.001), decreased TPS from (4.1±0.8) to (2.4±1.0)(t=14.718, P<0.001) and decreased Lund-Mackay CT score from (6.0±1.3) to (3.1±1.6)(t=17.012, P<0.001). The global response rate to omalizumab was 67.5%(79/117). The response rate in AA+AR (90.6%,29/32) was significantly higher than that in AA+CRSwNP (61.0%,36/59) and AA+AR+CRSwNP (53.8%,14/26) subgroups (χ2=11.144,P=0.004). Only 4 patients (3.4%,4/117) had mild side effects. Conclusion: The real-world study showed favorable effectiveness and safety of anti-IgE monoclonal antibody for treatment of allergic UAD. To provide basis for preventing the progress and precise treatment of allergic UAD.
01 Feb 2023Pharmacology research & perspectives
A humanized anti‐cocaine mAb antagonizes the cardiovascular effects of cocaine in rats
Article
Author: Marckel, Jordan A. ; Rubinstein, Jack ; Koch, Sheryl E. ; Norman, Andrew B.
Abstract:
The recombinant monoclonal anti‐cocaine antibody, h2E2, sequesters cocaine in plasma increasing concentrations more than 10‐fold. The increased levels of cocaine in the plasma could have detrimental peripheral effects, particularly on the cardiovascular system. We investigated the duration and magnitude of the effect of cocaine on the rat heart, and if h2E2 could antagonize that effect. Echocardiography was used to evaluate cardiac function under isoflurane anesthesia, while a tail‐cuff was used to measure blood pressure. Cocaine was delivered intravenously and the rats were continuously monitored for a total of 45 min. Echocardiography measurements were recorded every 5 min and blood pressure measurements were recorded throughout the duration of the experiment using 30‐s cycles. ECG recordings were taken simultaneously with the echocardiography measurements. An increase in ejection fraction was seen after the cocaine push with the maximum change occurring at 25 min. Treatment with h2E2 1 h before the cocaine push did not have any effect on cardiac parameters. Subsequent cocaine treatment had no effect on the ejection fraction, indicating that the antibody‐bound cocaine does not affect the heart. This antagonism of cocaine's effects was greatly decreased after 1 week and entirely absent after 1 month. Cocaine in the presence of h2E2 is pharmacologically inert and h2E2 may have additional clinical utility for reversing cocaine effects on the cardiovascular system.
1
News (Medical) associated with Omalizumab biosimilar (CSPC)100 Deals associated with Omalizumab biosimilar (CSPC)
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R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Chronic Urticaria | CN | 26 Sep 2024 |
Developing
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Asthma | NDA/BLA | CN | - | |
| Autoimmune Diseases | Phase 2 | CN | 29 Aug 2022 | |
| Autoimmune Diseases | Phase 2 | EU | 29 Aug 2022 |
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Clinical Result
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Phase 3 | - | hvorlmfixj(zbnltepyaa) = 高度相似，无临床意义上的差异 elsfprxdyz (mbjcrqsnpk ) View more | Similar | 08 Oct 2024 | |||
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