Plasma Products, Vaccines Products, Gene Recombinant Protein Products

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1.Company Introduction

Founded in 1992, Hualan Biological Engineering Inc. is an innovative pilot company of national grade engaging in the research, production and sales of plasma products, vaccines, recombinant protein and other biological products. The business of Hualan Biological Engineering Inc. is over 6 provinces in China and it has 31 subsidiaries, 7.6 billion of total production value and more than one hundred billion of market value. The company produces the first marketed Influenza A (H1N1) Vaccine, (Split, Inactivated) in the globe, and is the first company whose plasma products gained GMP certificate in China, and the first company whose influenza vaccine gained the WHO Pre-Qualification. The Influenza Vaccine (Split Virion), Inactivated has been exported to Europe, Africa, Southeast Asia and other countries. While the plasma products have been exported to India, Peru, El Salvador, Paraguay, Pakistan and other countries. 

Hualan Biological Bacterin Inc., a holding subsidiary of the company, is engaged in the R & D, production and sales of vaccines. At present, there are six kinds of vaccines on the market, including Influenza Vaccine (Split Virion), Inactivated, H1N1 Influenza A Vaccine (Split Virion), Inactivated, Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, Group A and C Meningococcal Polysaccharide Vaccine, Group ACYW135 Meningococcal Polysaccharide Vaccine, and Recombinant Hepatitis B Vaccine (Hansenula polymorpha).

Hualan Genetic Engineering Co., Ltd is a joint-stock company of Hualan Biological Engineering Inc. The company mainly engages in the R&D, and production of innovative drugs and biosimilar drugs, devoting to building the largest monoclonal antibody drug production base in China.

Shengming Bio is wholly owned subsidiary of Hualan Group and can provide CRO and CMO services related to monoclonal antibody drugs.

2. Products introduction

The major businesses of the company includes three types: research and development, production and sales of plasma products, vaccines products, gene recombinant protein products.

The main products are as follows:

Vaccines Products

Influenza Vaccine (Split Virion), Inactivated: Other than the WHO-PQ, the Influenza Vaccine (Split, Virion), Inactivated of Hualan Biological Bacterin Inc. has obtained the registration certificate and GMP of Ukraine, Ivory Coast, Pakistan, Philippines, Indonesia and Dominica.

The vaccine is prepared from influenza virus type A and B prevalent strains recommended by WHO. The virus strains are inoculated in embryo eggs. After incubation, the virus liquid is harvested. The vaccine is prepared by inactivation, concentration, purification and splitting. The vaccine is a slightly opalescent liquid.

It stimulates the body to produce immunity against influenza virus, and is used to prevent influenza caused by this strain of virus.

The vaccine is prepared from influenza virus type A and B prevalent strains recommended by WHO. The virus strains are inoculated in embryo eggs. After incubation, the virus liquid is harvested. The vaccine is prepared by inactivation, concentration, purification and splitting. The vaccine is a slightly opalescent liquid.

Vaccination Subjects: The vaccine is approved for use in people aged 3 years old and above, especially in vulnerable people and high risk population for influenza complications, such as children, the elderly, the weak and people in influenza epidemic areas.

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent: The vaccine can stimulate the body to produce immunity against influenza viruses, and can be used for the prevention of influenza caused by relevant strains of influenza viruses.

Gene Recombinant Protein Products

Human Albumin: The product is used for the treatment for shocks caused by hemorrhagic trauma or burn, increased intracranial pressure caused by cerebral edema or injury, edema or ascites caused by cirrhosis or nephrosis, preventing hypoproteinemia; treatment for hyperbilirubinemia of newborns; the adjuvant therapy to cardiopulmonary bypass, burn or hemodialysis, and the treatment for adult respiratory distress syndrome (ARDS).

Human Immunoglobulin (pH4) for Intravenous Injection: the product is used for the treatment for primary immunoglobulin deficiency diseases, such as X-linked hypoimmunoglobinemia, common variable immunodeficiency disease (CVID), IgG subclass deficiency, etc.; secondary immunoglobulin deficiency diseases, such as severe infections, neonatal sepsis, etc.; autoimmune diseases (AID), such as primary thrombocytopenic purpura, Kawasaki disease (KD), etc.

Human Immunoglobulin: the product is used to prevent measles and infectious hepatitis, and will enhance the therapeutic effect in preventing some severe bacterial and viral infections if used with antibiotics.

Human Hepatitis B Immunoglobulin: the product is mainly used to prevent hepatitis B, and indicated for newborns whose mothers are HBsAg positive; people with accidental infection; close contacts with hepatitis B patients or hepatitis B virus carriers.

Human Rabies Immunoglobulin: the product is indicated for passive immunization of persons with wounds bitten or scratched by rabid dogs or other animals carrying rabies virus.

Human Tetanus Immunoglobulin: the product is mainly used for prevention and treatment of tetanus, especially indicated for those with anaphylaxis to tetanus antitoxin (TAT).

Human Coagulation Factor VIII: this product has a corrective effect on coagulation disorders that caused by the lack of human coagulation factor Ⅷ. It is mainly used in the prevention and treatment of hemorrhagic symptoms caused by hemophilia A and acquired coagulation factor Ⅷ deficiency and the surgical bleeding treatment of this kind of patients.

3. Product pictures

Plasma products:

Human Tetanus Immunoglobulin

Influenza Vaccine (Split, Virion), Inactivated

Influenza Vaccine(Split, Virion), Inactivated, Quadrivalent

4. Economic and trade demand

4.1.Look for trade and cooperation partners:Partners can be distributors, manufacturers. Partners should have a good sales team, try their best to cooperate and finish registration matters, communicate with the MOH, give timely feedback, actively explore the market, place orders.

4.2.Shengming Bio is wholly owned subsidiary of Hualan Group and can provide CRO and CMO services related to monoclonal antibody drugs.

The contents of services include screening mono antibody, evaluation, process R&D, drug analysis, preparation development, approval production, filling and packaging, labeling, etc.

CMO (Contract Manufacture Organization) Business: With the world-class pilot plant and manufacturing base in conformity with US and European standard, we could contract manufacture (CMO) products, filling and lyophilization for clinical application and large-scale production.

5. Contact person

Company name:Hualan Biological Bacterin Inc.

Contact Person:  Kevin Cai/ Kathy Zhang

Tel: 0086-373-3559991

E-mail:export@hualanbio.com,  sales@hualanbio.com

Address:Jia No.1-1, Hualan Ave., Xinxiang, Henan, China    

Contact

IT Center, China Council for the Promotion of International Trade (CCPIT)

+86-10-82217954

tradeinvest@ccpit.org

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