Last update 21 Nov 2024

Omalizumab biosimilar (CSPC)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

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

IgE

Mechanism

IgE inhibitors(Immunoglobulin E inhibitors)

Therapeutic Areas

Immune System DiseasesRespiratory DiseasesSkin and Musculoskeletal Diseases

Active Indication

Chronic UrticariaAsthmaAutoimmune Diseases

Inactive Indication-

Originator Organization

Synermore Biologics (Suzhou) Co., Ltd.

Active Organization

Synermore Biologics Co., Ltd.CSPC Megalith Biopharmaceutial Co., Ltd.

Inactive Organization

CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (26 Sep 2024),

Chronic Urticaria

Regulation-

Gene Sequence

Sequence Code 143601H

The sequence is quoted from: *****

Sequence Code 81670L

The sequence is quoted from: *****

Clinical Trials associated with Omalizumab biosimilar (CSPC)

EUCTR2021-000149-42-HU / Unknown statusPhase 3

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

Start Date16 Aug 2021

Sponsor / Collaborator

Synermore Biologics Co., Ltd.

CTR20210213 / CompletedPhase 3

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

主要研究目的：验证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疗效的一致性。次要研究目的： 1. 评价SYN008与注射用奥马珠单抗（Xolair）对难治性慢性自发性荨麻疹患者的安全性； 2. 评价SYN008与注射用奥马珠单抗（Xolair）对难治性慢性自发性荨麻疹患者的免疫原性； 3. 基于次要疗效终点，评价SYN008与注射用奥马珠单抗（Xolair）对难治性慢性自发性荨麻疹患者的疗效。

[Translation]

Main study objectives: To verify the consistency of efficacy of SYN008 and Omalizumab for injection (Xolair) in the treatment of patients with refractory chronic spontaneous urticaria. Secondary study objectives: 1. To evaluate the safety of SYN008 and Omalizumab for injection (Xolair) in patients with refractory chronic spontaneous urticaria; 2. To evaluate the immunogenicity of SYN008 and Omalizumab for injection (Xolair) in patients with refractory chronic spontaneous urticaria; 3. Based on secondary efficacy endpoints, evaluate the efficacy of SYN008 and Omalizumab for injection (Xolair) in patients with refractory chronic spontaneous urticaria.

Start Date23 Jul 2021

Sponsor / Collaborator

CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.

NCT04944602 / Unknown statusPhase 3

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

• This study is a multicenter, randomized, double-blind, parallel-group, positive-controlled phase III study to evaluate the therapeutic equivalence of SYN008 versus omalizumab for injection (Xolair®) in the treatment of CSU patients who remain symptomatic despite antihistamine treatment.

Start Date01 Jul 2021

Sponsor / Collaborator

CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

100 Clinical Results associated with Omalizumab biosimilar (CSPC)

100 Translational Medicine associated with Omalizumab biosimilar (CSPC)

100 Patents (Medical) associated with Omalizumab biosimilar (CSPC)

Literatures (Medical) associated with Omalizumab biosimilar (CSPC)

25 Apr 2023·International journal of molecular sciences

A Novel Rabbit Anti-Myoglobin Monoclonal Antibody's Potential Application in Rhabdomyolysis Associated Acute Kidney Injury

Article

Author: Gong, Yanhua ; Li, Ning ; Han, Lu ; Qiao, Ou ; Wang, Xinyue

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 technol.With the help of DNA sequencing and a mol. 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, immunohistochem., 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 2023·Zhonghua 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: Sui, H J ; Cong, T C ; Zhen, Z ; Wang, Q G ; Huang, J J ; Hu, Y

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 2023·Pharmacology Research & Perspectives

A humanized anti‐cocaine mAb antagonizes the cardiovascular effects of cocaine in rats

Article

Author: Rubinstein, Jack ; Koch, Sheryl E. ; Marckel, Jordan A. ; Norman, Andrew B.

AbstractThe 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.

News (Medical) associated with Omalizumab biosimilar (CSPC)

09 Jun 2021

·www.globenewswire.com

A Comprehensive Analysis of 18+ Key Companies Strengthening Chronic Spontaneous Urticaria Pipeline | Insights by DelveInsight

Los Angeles, June 08, 2021 (GLOBE NEWSWIRE) -- A Comprehensive Analysis of 18+ Key Companies Strengthening Chronic Spontaneous Urticaria Pipeline | Insights by DelveInsight For the treatment of Chronic Spontaneous Urticaria, there are several drugs being developed by different pharmaceutical industries with different routes of administration like oral, subcutaneous, intravenous which could be chosen according to the affordability and feasibility of an individual. DelveInsight’s ‘Chronic Spontaneous Urticaria Pipeline Insights’ report offers a holistic coverage of the current treatments and pipeline therapies and landscape in different stages of development from pre-clinical till late-stage, along with dormant, inactive and abandoned therapeutic agents. Some of the key pointers from the Chronic Spontaneous Urticaria Pipeline report: Request for Sample to know more about the key pharma company and therapy expected to grab maximum share @ Chronic Spontaneous Urticaria Emerging Therapies and Forecast Chronic Spontaneous Urticaria: Overview Chronic Urticaria (CU) is a condition of the skin caused by a plenitude of factors such as environmental irritants, your immune system, genetics, or in response to a bacterial, fungal, or viral infection. Based on the cause, it can be of two types Chronic Idiopathic Urticaria (also called chronic spontaneous urticaria) and Chronic Inducible Urticaria (also called physical urticaria). Chronic Spontaneous Urticaria was previously referred to as Chronic Idiopathic Urticaria, however, the term is no longer used as many cases have an autoimmune basis. For more information on emerging drugs, visit Chronic Spontaneous Urticaria Pipeline Analysis Chronic Spontaneous Urticaria Drug Pipeline Assessment Request for Sample to know more @ Chronic Spontaneous Urticaria Pipeline Analysis, Key Companies and Futuristic Trends Chronic Spontaneous Urticaria Therapeutics Assessment The Chronic Spontaneous Urticaria Pipeline report proffers comprehensive coverage of the active pipeline candidates segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Connect with our Business Executive for Asset Prioritization Services and Consulting Solutions Scope of the Chronic Spontaneous Urticaria Pipeline Report Coverage: GlobalKey Players: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, GlaxoSmithKline, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, Amgen, and others. Key Chronic Spontaneous Urticaria Pipeline Therapies: UB-221, GBR 310, Ligelizumab, UCB8600, Antolimab, Dupilumab, GI-301, CDX-0159, LY3454738, Fenebrutinib, GS-4059, Nucala, SYN008, BP001, Tezepelumab and others. Reach out @ Chronic Spontaneous Urticaria Pipeline: Novel therapies and Emerging technologies Table of Contents Learn more about the report offerings @ Chronic Spontaneous Urticaria Emerging Therapies, Treatments and Ongoing Clinical Trials Related Reports Chronic Spontaneous Urticaria MarketDelveInsight’s ‘Chronic spontaneous urticaria (CSU) – Market Insights, Epidemiology, and Market Forecast—2030’ report. Chronic Inducible Urticaria Market ForecastDelveInsight’s ‘Chronic Inducible Urticaria Market Insights, Epidemiology, and Market Forecast-2030’ report. Scleroderma MarketDelveInsight's " Scleroderma Market Insights, Epidemiology, and Market Forecast-2030" report. Skin Neoplasms MarketDelveInsight's "Skin Neoplasms - Market Insights, Epidemiology, and Market Forecast-2030" report. Soft Tissue Defect MarketDelveInsight's "Soft Tissue Defect - Market Insights, Epidemiology, and Market Forecast-2030" report. Uremic Pruritus MarketDelveInsight's "Uremic Pruritus (UP) - Market Insights, Epidemiology, and Market Forecast-2030" report. Warts MarketDelveInsight's "Warts Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Highlights from ASCO20218 most common allergensDeadliest infectious diseasesChronic Hand Eczema Market Analysis and Forecast About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

100 Deals associated with Omalizumab biosimilar (CSPC)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Urticaria	CN	CSPC Megalith Biopharmaceutial Co., Ltd.	26 Sep 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Asthma	NDA/BLA	CN	CSPC Megalith Biopharmaceutial Co., Ltd.	-
Autoimmune Diseases	Phase 2	EU	Synermore Biologics Co., Ltd.	29 Aug 2022
Autoimmune Diseases	Phase 2	CN	Synermore Biologics Co., Ltd.	29 Aug 2022
Chronic Urticaria	Preclinical	-	CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.	01 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20210213 (Company_Website) Manual	Phase 3	Chronic Urticaria	-	恩益坦	(ernaookihf) = 高度相似，无临床意义上的差异 zljmeuvpbh (izlmeuqira ) View more	Similar	08 Oct 2024
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