[Translation] An open, single-arm, multicenter clinical trial to evaluate the efficacy and safety of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia

主要目的：评价新型静注人免疫球蛋白（10%）治疗原发免疫性血小板减少症（ITP）的疗效，通过分析首次用药治疗后7天内受试者血小板计数≥30×109/L并且提高到基线2倍以上的受试者比例，评价贵州泰邦生物制品有限公司生产的静注人免疫球蛋白（10%）的疗效。次要目的： 1)通过其它次要疗效指标，观察和评价疗效差异； 2)观察和评价安全性。

[Translation]

Primary purpose: To evaluate the efficacy of new intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia (ITP), and to evaluate the efficacy of intravenous human immunoglobulin (10%) produced by Guizhou Taibang Biological Products Co., Ltd. by analyzing the proportion of subjects with platelet count ≥30×109/L and increased to more than 2 times the baseline within 7 days after the first medication. Secondary objectives: 1) Observe and evaluate the difference in efficacy through other secondary efficacy indicators; 2) Observe and evaluate safety.

Start Date10 Jul 2020

Sponsor / Collaborator

Guizhou Taibang Biological Products Co., Ltd.

CTR20200912

/ RecruitingPhase 1

静注炭疽人免疫球蛋白Ⅰ期安全耐受性和药效动力学临床试验

[Translation] Phase I safety, tolerability and pharmacodynamics clinical trial of intravenous anthrax human immunoglobulin

1. 观察健康受试者单次给予静注炭疽人免疫球蛋白的耐受性和安全性； 2. 观察静注炭疽人免疫球蛋白在健康受试者体内的药效动力学行为，并计算药效动力学参数。

[Translation]

1. To observe the tolerability and safety of a single intravenous injection of anthrax human immune globulin in healthy subjects; 2. To observe the pharmacodynamic behavior of intravenous anthrax human immune globulin in healthy subjects and calculate the pharmacodynamic parameters.

Start Date16 Jun 2020

Sponsor / Collaborator

Guizhou Taibang Biological Products Co., Ltd.

[+1]

CTR20170096

/ Active, not recruitingPhase 3

评价人凝血因子Ⅷ治疗甲型血友病的安全性和有效性的单臂、开放性、多中心III期临床试验

[Translation] A single-arm, open-label, multicenter phase III clinical trial to evaluate the safety and efficacy of human coagulation factor VIII in the treatment of hemophilia A

评价贵州泰邦生产的人凝血因子Ⅷ制剂治疗甲型血友病患者的安全性和有效性。

[Translation]

To evaluate the safety and efficacy of human coagulation factor VIII preparation produced by Guizhou Taibang in the treatment of patients with hemophilia A.

Start Date-

Sponsor / Collaborator

Guizhou Taibang Biological Products Co., Ltd.

100 Clinical Results associated with Guizhou Taibang Biological Products Co., Ltd.

0 Patents (Medical) associated with Guizhou Taibang Biological Products Co., Ltd.

Literatures (Medical) associated with Guizhou Taibang Biological Products Co., Ltd.

01 Jan 2023·PeerJ

Parvovirus B19 DNA and antibodies in Chinese plasma donors, plasma pools and plasma derivatives.

Article

Author: Wang, Zongkui ; Ye, Shengliang ; He, Xuexin ; Su, Na ; Zhang, Rong ; Liu, Qing ; Jiang, Peng ; Ye, Xiangzhong ; Cao, Dawei ; Zhang, Yu ; Han, Jinle ; Li, Changqing ; Sun, Pan ; Yin, Yongsheng ; Ji, Shangzhi ; Ma, Li ; Cao, Haijun ; Zhao, Xuemei ; Chen, Yunhua ; Fan, Jiajin ; Du, Xi ; Lu, Kuilin

Background:

Human parvovirus B19 (B19V) is a common contaminant found in plasma pools and plasma derivatives. Previous studies were mainly focused on limited aspects, further assessment of prevalence of B19V DNA and antibodies in plasma donors, the contamination of B19V in pooled plasma and plasma derivatives should be performed in China.

Study Design and Methods:

Individual plasma donors' samples from four provinces and pooled plasma from four Chinese blood product manufacturers were collected and screened using B19V DNA diagnostic kits between October 2018 and May 2020. The positive samples were investigated for the seroprevalence of B19V antibodies and subjected to sequence analysis and alignment for phylogenetic studies. Moreover, 11 plasma donors who were B19V DNA-positive at their first testing were also followed during the later donation period. Additionally, 400 plasma pools and 20 batches of plasma derivatives produced by pooled plasma with a viral load of B19V DNA exceeding 10⁴IU/mL were also collected and tested for B19V DNA and antibodies.

Objectives:

To comprehensively and systematically determine the frequency and viral load of B19V DNA in plasma donors, pooled plasma, and plasma derivatives from four Chinese blood product manufacturers.

Results:

A total of 17,187 plasma donors were analyzed and 44 (0.26%) specimens were found positive for B19V DNA. The quantitative DNA levels ranged from 1.01 × 10¹ to 5.09 × 10¹² IU/mL. Forty-four DNA-positive specimens were also investigated for the seroprevalence of B19V antibodies, 75.0% and 2.3% of which were seropositive for B19V IgG and IgM antibodies, respectively. The phylogenic analyses showed that the prevalent genotypes in the four provinces' plasma donors belonged to B19V Genotype 1. Eleven individual plasma donors who were B19V DNA-positive at the first donation were then followed for a period, and in general, the DNA levels of B19V gradually decreased. Moreover, 64.8% (259/400) of the pooled plasma was contaminated by B19V, with concentrations of 1.05 × 10⁰-3.36 × 10⁹IU/mL. Approximately 72.6% of the DNA-positive plasma pools were only moderately contaminated (<10⁴ IU/mL), while 27.4% contained >10⁴ IU/mL. Twenty batches of plasma derivatives produced by pooled plasma with a viral load of B19V DNA exceeding 10⁴IU/mL were also tested. B19V was detected in 5/5 PCC samples and 5/5 factor VIII samples but was not found in the intravenous immune globulin and albumin samples.

Conclusion:

The contamination of B19V in pooled plasma and plasma-derived clotting factor concentrates is serious. Whether B19V nucleic acid testing (NAT) screening of plasma and plasma derivatives is launched in China, blood product manufacturers should spontaneously perform B19V NAT screening in plasma donors and mini-pool plasma. These measures can ensure that samples with high titer B19V DNA are discarded in order to prevent and control this transfusion transmitted virus.

01 May 2017·Journal of pharmaceutical and biomedical analysisQ3 · MEDICINE

Concentrations of antibodies against β-amyloid 40/42 monomer and oligomers in Chinese intravenous immunoglobulins

Q3 · MEDICINE

Article

Author: Yuan, Jing ; Li, Changqing ; Liu, Fengjuan ; Ma, Li ; Wang, Zongkui ; Zeng, Renyong ; Jiang, Peng ; Du, Xi ; Ye, Shengliang ; Cao, Haijun ; Chen, Yunhua ; Hou, Mingxia

Intravenous immunoglobulin (IVIg) preparations are being investigated as a potential agent for treatment or prevention of Alzheimer's disease (AD). Antibodies towards soluble β-amyloid (Aβ) contained in IVIg were considered to be the major component contributing to the beneficial effect of the preparations in pilot studies. This study compared the antibody concentrations against Aβ in Octagam^® IVIg (Octapharma) and 9 IVIg preparations from different Chinese manufacturers by ELISA, using Aβ40 monomer, Aβ40 soluble oligomers, Aβ42 monomer and Aβ42 soluble oligomers as the antigens. The results showed that each preparation contained different antibody levels against the four Aβ forms. The median values of the four antibody concentrations in Chinese IVIg preparations were 16.53, 8.47, 24.36 and 33.25μg/mL, which were remarkably higher than that in Octagam^® IVIg (1.66, 2.07, 4.61 and 4.64μg/mL). Moreover, the anti-Aβ42 oligomer antibody levels in almost all IVIg preparations were higher than the anti-Aβ42 monomer antibody, and the concentrations of anti-Aβ42 antibodies in most of the IVIg preparations were significantly higher than that of anti-Aβ40 antibodies. These findings will contribute to an increased understanding of the uniqueness of Chinese IVIg preparations, and could provide support for a trial of a Chinese IVIg product in AD patients.

01 Jan 2017·Journal of pharmaceutical and biomedical analysisQ3 · MEDICINE

Demonstration of the IgG antibody repertoire against the bacteria Escherichia coli in Chinese intravenous immunoglobulins

Q3 · MEDICINE

Article

Author: Wang, Zongkui ; Yuan, Jing ; Li, Changqing ; Liu, Fengjuan ; Lei, Min ; Ma, Li ; Jiang, Peng ; Cao, Haijun ; Du, Xi ; Ye, Shengliang ; Chen, Yunhua

Intravenous immunoglobulin (IVIg) is produced by pooling plasma from thousands of healthy blood donors, and the diversity of the antibody is critical for the clinical efficacy of IVIg. This study investigated the antibody diversity of Chinese IVIg. Firstly, 2-dimensional gel electrophoresis and immunoblotting with protein extracts of Escherichia coli (E. coli) O157:H7 were used to study IgG antibody repertoire of 8 IVIg preparations from different Chinese manufacturers. This was followed by the identification of the antibody-reactive proteins of E. coli by mass spectrometry and the sequence similarity of the proteins was aligned by bioinformatics analysis. The results showed that all IVIg preparations expressed a large range of antibody reactivities against E. coli proteins. 94-238 antigens were recognized by the 8 IVIg preparations. 33 interesting target antigens were selected and identified as 29 different proteins, mainly including membrane proteins, molecular chaperones, metabolism enzymes, and proteins involved in cell cycle processes. Additionally, these antigens were highly conserved proteins which were found extensively in a variety of other pathogenic microorganisms. Our study indicated that Chinese IVIg preparations recognized a large range of high conserved proteins which play key roles in pathogenic microorganisms, and showed each IVIg had its own distinct antibody repertoire.

News (Medical) associated with Guizhou Taibang Biological Products Co., Ltd.

05 Sep 2014

·www.biospace.com

China Biologic Products To Participate In Upcoming Investor Conferences

BEIJING, Sept. 5, 2014 /PRNewswire/ -- China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, is scheduled to participate in the upcoming conferences: Morgan Stanley Global Healthcare Conference, to be held September 8-10, 2014 at the Grand Hyatt New York. Management is scheduled to meet with institutional investors throughout September 9-10. Morgan Stanley Asia Pacific Healthcare Day, to be held September 11, 2014 at the Boston Harbor Hotel. Management is scheduled to meet with institutional investors throughout the day. Aegis Healthcare & Technology Conference, to be held September 10-13, 2014 at the Wynn Las Vegas. Management will present at 1:30 p.m. local time on September 12 and meet with institutional investors throughout the day. For additional information, please contact the respective institutional sales representative at each sponsoring bank. About China Biologic Products, Inc. China Biologic is a leading plasma-based biopharmaceutical company in China. The Company's products are used as critical therapies during medical emergencies and for the prevention and treatment of life-threatening diseases and immune-deficiency related diseases. China Biologic is headquartered in Beijing and manufactures over 20 different dosages of plasma-based products through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co., Ltd. and Guizhou Taibang Biological Products Co., Ltd. The Company also has an equity investment in Xi'an Huitian Blood Products Co., Ltd. The Company sells its products to hospitals and inoculation centers, as well as distributors, in China. For additional information, please see the Company's website, . Contact: China Biologic Products, Inc. Mr. Ming Yin Senior Vice President Phone: +86-10-6598-3099 Email: ir@chinabiologic.com ICR Inc. Mr. Bill Zima Phone: +86-10-6583-7511 or +1-646-405-5191 E-mail: bill.zima@icrinc.com SOURCE China Biologic Products, Inc. Hey, check out all the research scientist jobs. Post your resume today!

100 Deals associated with Guizhou Taibang Biological Products Co., Ltd.

100 Translational Medicine associated with Guizhou Taibang Biological Products Co., Ltd.

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Pipeline

Pipeline Snapshot as of 12 Mar 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)	Measles More	Approved
Human prothrombin complex concentrate(Guizhou Taibang Biological Products Co., Ltd.) ( F10 x factor IX x factor VII x thrombin )	Hypoprothrombinemias More	Approved
Factor VIII(Guizhou Taibang Biological Products) ( F10 )	Hemophilia A More	Phase 3
Anthrax Immune Globulin (Taibang Biological)	Anthrax More	Phase 1

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