China Biologic Products has obtained China State Food and Drug Administration (SFDA) approval to initiate clinical trials for its human fibrinogen.
As part of the approval, the company will start phase III clinical trials including the efficacy study, since phases I and II are not required for this product.
China Biologic Products president and chief executive officer Chao Ming Zhao said human fibrinogen is made using company’s internally developed new manufacturing process, which improves product quality.
"The new process also increases plasma utilization and production efficiency," Zhao added.
"The phase III clinical trials are expected to last about two years, after which we will begin commercial production and sales, assuming the clinical trials prove that the product provides the safe and effective treatments we expect."
Human fibrinogen is used to treat congenital fibrinogen and acquired fibrinogen deficiencies.