R&D-Beijing Tiantan Biological Products Co.,Ltd

R&D Achievements

In Janurary 2018，BTBP established the CNBG Blood Products R&D Center. The center has integrated the R&D technologies and talents across the group and built a comprehensive blood product research and innovation system. It standardized and managed the entire chain of new product development, quality control, registration and application, and clinical trial operation, promoting the company's high-quality development through scientific research and innovation. In 2023, the 4th generation of 10% Human Immunoglobulin for Intravenous Injection (蓉生静丙® 10%) manufactured with chromatography process is the first in China approved for marketing, and the Recombinant Human Coagulation Factor VIII for Injection has also obtained the Marketing Authorization.

Marketing Authorizations obtained since 2018

Effective patent authorizations

Scientific papers

6 Technology Platforms

Virus Safety Study

P2 Laboratory

Sychronizing with the new products development, continuously optimize the virus inactivation/removal method to improve the products safety and reduce the potential risk of pathogenic microorganism transmission

Plasma Comprehensive Utilization Research

Plasma Comprehensive Utilization Research Pilot Plant

Adopting leading domestic plasma protein separation and purification technology to develope new products and upgrade the manufacturing processes of the marketed products.

Plasma Protein Chromatographic Separation

Plasma Separation and Purification Device

The plasma proteins are separated and purifed by multi-step continuous chromatography technology. It is mainly used for prospective technical research and the development of new blood products for rare diseases.

Genetic Recombinant Products Development

Bioreactor

The R & D center owns core technologies such as genetic engineering cell line construction and screening, upstream cell large-scale culturing, downstream separation and purification, formulation, and long-acting fusion protein devleopment.

New Products Analysis and Tests

ICP-MASS

Develope, validate and transfer the new product testing methods, verify the new product quality, formulate testing standards, and develope testing methods for clinical researches.

Immunogloblin Products Development

Chromatography System

Develope high concentration immunoglobulin and new administration methods by combining low-temperature ethanol separation process with chromatographic separation; Develop hyperimmunoglobulins containing highly effective neutralizing antibodies targeting certain pathogenic microorganisms or specific antigens.

R&D Pipelines

The R&D center closely follows the development trends of the international blood product industry and established R&D pipelines around rare diseases(such as hemophilia), immunodeficiency, severe illness, infection, etc. It focuses on the production of new products such as high concentration human immunoglobulin, plasma-derived coagulation factor, recombinant coagulation factor, and micro protein products. While maintaining a leading position in the domestic industry in the research and development of recombinant human coagulation factor and human immunoglobulin products, it closely tracks cutting-edge innovations, forward-looking technologies and new product varieties in the industry.

Applying for Clinical Trials

Clinical Trails in Process

Applying for Production

Human Immunoglobulin for Subcutaneous Injection

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Indications: primary immunodeficiency disease (PID), immunoglobulin G subclass deficiency

Applying for Clinical Trials

Clinical Trails in Process

Applying for Production

Recombinant Human Coagulation Factor VIIa for Injection

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Indications: for the treatment of bleeding in some congenital hemophilia patients, and the prevention and treatment of bleeding during surgical or invasive procedures.

Applying for Clinical Trials

Clinical Trails in Process

Applying for Production

Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

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Indications: control and prevention of bleeding in patients with hemophilia A, surgical prevention in patients with hemophilia A

Applying for Clinical Trials

Clinical Trails in Process

Applying for Production

Human Coagulation Factor IX

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Indications: hemorrhagic treatment for patients with coagulation factor IX deficiency (Hemophilia B).

项目名称：

注射用重组人凝血因子ⅦA

适用于下列患者群体出血的治疗，以及外科手术或有创操作出血的防治。
（1）凝血因子Ⅷ或Ⅸ的抑制物＞5个BETHESDA单位（BU）的先天性血友病患者；
（2）预计对注射凝血因子Ⅷ或凝血因子Ⅸ，具有高记忆应答的先天性血友病患者；
（3）获得性血友病患者；
（4）先天性凝血因子Ⅶ（FⅦ）缺乏症患者；
（5）具有血小板膜糖蛋白ⅡB-ⅢA（GPⅡB-ⅢA）和/或人白细胞抗原（HLA）抗体和既往或现在对血小板输注无效或不佳的血小板无力症患者。