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The new IVIG products boast improvements in purity, safety, and yield.
China Biologic Products announced on Nov. 4, 2015 that the company has received approval from the China Food and Drug Administration (CFDA) to begin clinical trials on its next-generation intravenous immunoglobulin (IVIG) products. The company expects to complete these clinical trials over the next 24 months and begin commercial production of its IVIG product in its new fractionation facility in Shandong by 2018.
Ming Yin, senior vice-president of China Biologic, said his company is a pioneer for the manufacture of this new-generation IVIG. He noted the company has also successfully developed a laboratory-scale manufacturing process and virus inactivation techniques for its IVIG products.
The new version of China Biologic Products' IVIG therapy is reportedly associated with higher purity, better safety, and improved product yields. Because the formulation does not contain sugar, said Yin, there may be fewer immunogenicity issues involving the kidneys.
Plasma collection growth strategy
To meet growing demand for its plasma products, China Biologic Products has had to purchase approximately 20% of its raw materials (source plasma and plasma pastes) from outside vendors for the production of its human albumin and IVIG products. In April 2015, the company announced it purchased approximately 143 tons of source plasma and plasma pastes from Xinjiang Deyuan Bioengineering Co., Ltd. for approximately $22.4 million. This purchase will be used to manufacture IVIG product for market releases in 2015 and 2016, and through a new strategic collaboration agreement between Guizhou Taibang and Xinjiang Deyuan, China Biologic Products will have the ability to purchase no less than 500 tons of source plasma over the next three years. Yin said the purchase of plasma "serves as an important growth catalyst for China Biologic," allowing the company to secure a stable supply of plasma during the next three years as it continues to expand its own in-house collection capacity.
The company, through its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., opened a new plasma collection center in Zaozhuang City, Shandong Province in October 2015. The facility is the ninth plasma collection station operating in the Shandong Province, according to a company press release, and the company has plans to open future collection locations in Hebei Province and in Daming County.
Sources: Seeking Alpha, China Biologic Products