China Biologic Gets CFDA Clinical Trial Approval For Human Fibrin Sealant

(RTTNews) - China Biologic Products Holdings, Inc. (CBPO) a plasma-based biopharmaceutical company in China, said that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., recently obtained approval from the China Food and Drug Administration or CFDA to begin human clinical trials on its Human Fibrin Sealant product.

Fibrin Sealant is intended to be used as an adjunct to hemostasis on patients undergoing surgery in case traditional surgical techniques such as sutures, ligatures, and cauteries are ineffective or impractical.

China Biologic expects to commence clinical trials for the Fibrin Sealant product in 2018 and to take at least one year to complete the trials.

David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic said, "Fibrin Sealant can be used in a variety of surgical applications to manage bleeding from surfaces or cavities that are not amenable to suturing, electrosurgery, or other specialized techniques. Our Fibrin Sealant, sourced from human plasma, will provide medical practitioners with better efficacy, safety and greater convenience of use when compared to other fibrin glue products sourced from animal blood."