YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (006280.KS) today announced the approval of GreenGene F (Beroctocog alfa) [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with haemophilia A in China by the National Medical Products Administration (NMPA). GreenGene F was initially approved by the Korean health authority in 2010 for control and prevention of bleeding episodes in patients with haemophilia A.
"The approval of GreenGene F in China marks an important milestone for GC Pharma and supports our ongoing commitment to treating patients living with rare disorder," said EC Huh, Ph.D., president of GC Pharma.
In the pivotal phase III clinical trial conducted in China, which served as the foundation for the approval, GreenGene F demonstrated efficacy in treating hemophilia patients. About 80 percent of patients showed improvement in symptoms within 8 hours after a single injection, meeting its primary efficacy endpoints of hemostasis and bleeding prevention. The trials also met of its secondary endpoints with 94 percent reduction of Annual Bleeding and Annual Joint Bleeding rates.
The trial also included patient-reported Quality of Life (QoL) metrics. Patients treated with ‘GreenGene F’ reported an improvement in hemophilia-related symptoms compared to before receiving the treatment. In terms of safety, there is no serious adverse events of death occurs in the trials.
Through a collaboration with GC China, a leading plasma-derived haemophilia products provider in China and also a GC Pharma’s affiliate company, GreenGene F will be available in China within the first half of next year.
GC Pharma previously announced the focusing Chinese market due to higher market growth potential. It is estimated that 60 percent of people in China with haemophilia A undiagnosed and untreated of undertreated. The Company continues to innovate in order to address some of the greatest challenges associated with hematologic disorders, including haemophilia.
About GC Pharma
GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Pharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company's legal name.
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