China Biologic Products Holdings, Inc. operates as a biopharmaceutical company that engages in the research, development, manufacturing and sales of human plasma-based biopharmaceutical products (plasma products) in the People’s Republic of China (China or PRC). The company also develops, manufactures and markets certain other biopharmaceutical products and regenerative medical biomaterial products.
The company operates its plasma business through a majority owned subsidiary, Shandong Taibang B...
China Biologic Products Holdings, Inc. operates as a biopharmaceutical company that engages in the research, development, manufacturing and sales of human plasma-based biopharmaceutical products (plasma products) in the People’s Republic of China (China or PRC). The company also develops, manufactures and markets certain other biopharmaceutical products and regenerative medical biomaterial products.
The company operates its plasma business through a majority owned subsidiary, Shandong Taibang Biological Products Co., Ltd., a company based in Tai’an, Shandong Province, and a wholly owned subsidiary, Guizhou Taibang Biological Products Co., Ltd., a company based in Guiyang, Guizhou Province. The company also holds a minority equity interest in Huitian, a plasma products company based in Xi’an, Shaanxi Province.
The company has a biopharmaceutical product portfolio covering approximately 20 different dosage forms of plasma products across nine categories and one chemical drug, placenta polypeptide. All of its plasma products and the placenta polypeptide product are prescription medicines administered in the form of injections. The company’s principal products are human albumin and immunoglobulin for intravenous injection (IVIG).
The company owns 80% equity interest in TianXinFu (Beijing) Medical Appliance Co., Ltd. (TianXinFu), a medical device company primarily engaging in manufacturing and sale of regenerative medical biomaterial products, including artificial dura mater and spinal dura mater products. Its pipeline products mainly include absorbable oral repair membrane for oral and maxillofacial surgery and the second generation artificial dura mater. In August 2019, the company acquired the remaining 20% equity interest in TianXinFu and as a result, TianXinFu became the company’s indirect wholly owned subsidiary.
The company operates through Biopharmaceutical Products and Biomaterial Products segments. Biopharmaceutical products include plasma products and placenta polypeptide.
Products
The company’s principal plasma products are its approved human albumin and IVIG products. Human albumin is principally used to treat critically ill patients by replacing lost fluid and maintaining adequate blood volume and pressure. IVIG products are primarily used to enhance specific immunity, a defense mechanism by which the human body generates certain immunoglobulin, or antibodies, against invasion by potentially dangerous substances. The company also has one chemical drug, placenta polypeptide. All of the company’s approved plasma products and the placenta polypeptide products are prescription medicines administered in the form of injections.
Human Albumin – 20%/10ml, 20%/25ml, 20%/50ml, 10%/100ml, 10%/20ml, 10%/50ml, 25%/50ml and 20%/50ml (10g, from factor IV): Used for the treatment of shock caused by blood loss trauma or burn; raised intracranial pressure caused by hydrocephalus or trauma; oedema or ascites caused by hepatocirrhosis and nephropathy; prevention and treatment of low-density-lipoproteinemia; and neonatal hyperbilirubinemia.
Human Immunoglobulin – 10%/3ml and 10%/1.5ml and IVIG – 5%/25ml, 5%/50ml, 5%/100ml and 5%/200ml: Used for the treatment of original immunoglobulin deficiency, such as X chain low immunoglobulin, familiar variable immune deficiency, immunoglobulin G secondary deficiency; secondary immunoglobulin deficiency, such as severe infection, newborn sepsis; and auto-immune deficiency diseases, such as original thrombocytopenia purpura or Kawasaki disease.
Human Hepatitis B immunoglobulin – 100 IU, 200IU and 400IU: Used for the prevention of measles and contagious hepatitis. When applied together with antibiotics, its curative effect on certain severe bacteria or virus infection might be improved.
Human Rabies Immunoglobulin – 100IU, 200IU and 500IU: Used for passive immunity from bites or claws by rabies or other infected animals. All patients suspected of being exposed to rabies are treated with a combined dose of rabies vaccine and human rabies immunoglobulin.
Human Tetanus Immunoglobulin – 250IU: Human Tetanus Immunoglobulin is used for the prevention and therapy of tetanus. Particularly applied to patients who have allergic reactions to tetanus antitoxin.
Placenta polypeptide – 4ml/vial: Placenta polypeptide is used of the treatment of cell immunity deficiency diseases, viral infection and leucopenia caused by various reasons, and assist in postoperative healing.
Factor VIII – 200IU and 300IU: Used of the treatment of coagulopathies, such as hemophilia A and increased concentration of coagulation factor VIII.
Human prothrombin complex concentrate – 300IU: Used of the treatment of congenital and acquired clotting factor II, VII, IX, X deficiency, such as Hemophilia B, excessive anticoagulant, and vitamin K deficiency, etc.
Human fibrinogen – 0.5g: Used for the treatment for lack of fibrinogen and increase human fibrinogen concentration.
Artificial Dura Mater: Dura substitutes are used when the patients’ dura could not be sutured satisfactorily and watertight closure is difficult to achieve.
Business Strategy
The key elements of the company's strategy include securing the supply of plasma, further strengthening of research and development capability, market development and network expansion, and organic growth complemented by acquisition of competitors and/or other new biopharmaceutical and medical device products.
Plasma Sourced from Xinjiang Deyuan Bioengineering Co., Ltd. (Xinjiang Deyuan)
In addition to its in-house collection, the company also outsources plasma from Xinjiang Deyuan pursuant to a cooperation agreement entered into with Xinjiang Deyuan and its controlling shareholder in August 2015 and supplemented by a supplementary agreement entered into in August 2018. Under these agreements, Xinjiang Deyuan had sold the company approximately 500 tonnes of source plasma in batches from August 2015 to August 2018 and agreed to sell to it approximately 500 tonnes of source plasma over a three year period from August 2018 to August 2021. As of December 31, 2019, an aggregate of 802 tonnes of plasma had been delivered to the company under these agreements.
Sales, Marketing and Distribution
Because all of its biopharmaceutical products are prescription drugs and the medical device products are used in surgeries, the company could only sell to hospitals and inoculation centers directly or through approved distributors. For 2019, direct sales to hospitals and inoculation centers represented approximately 49.0% of its total plasma products sales and the other biopharmaceutical and medical device products are mostly sold through distributors. The company sells biopharmaceutical and biomaterial products to hospitals, inoculation centers and distributors.
Research and Development
For the year ended December 31, 2019, the company’s total research and development expenses amounted to approximately $11.7 million.
Intellectual Property
The company held 105 issued patents and 48 pending patent applications in China for certain manufacturing processes and packing designs, as of December 31, 2019. The company also had 36 registered trademarks in China, as of December 31, 2019.
In addition, the company had registered four domain names, as of December 31, 2019, such as www.chinabiologic.com, www.ctbb.com.cn, www.taibanggz.com.cn and www.txfmedical.com.
Regulation
Due to the nature of the company’s products, it is supervised by various levels of the National Health Commission of the PRC and/or the National Medical Products Administration of the PRC. The company is also subject to other PRC regulations, including those relating to taxation, foreign currency exchange and dividend distributions.
History
The company was formerly known as China Biologic Products, Inc. and changed its name to China Biologic Products Holdings, Inc. in 2017.
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