GC scores 1st approval for local recombinant hemophilia treatment in China

GC said that it has obtained product approval from China’s National Medical Products Administration of China for GreenGene F, a hemophilia treatment. The company stressed that this is the first local recombinant hemophilia treatment to receive approval in China.

GC received the approval after meeting all of the major evaluation indicators in the Chinese clinical trial of GreenGene F.

As a result of the trial, GC confirmed that 80 percent of patients showed improvement in hemostasis and bleeding prevention, the primary endpoint of the trial, within eight hours after injecting the drug. The company also confirmed that the annual bleeding and joint bleeding rate, the secondary endpoint, increased by 94 percent.

According to the company, about 40 percent of all patients with hemophilia A in China receive treatment. So unlike other countries where there are few new prescriptions, the country has ample market potential.

“This approval will speed up the penetration of the rare disease treatment market in China along with the approval of Hunterase, a treatment for Hunter syndrome, last year,” the company said.

GC CEO Huh Eun-chul said, “With this approval, efforts that have been made to treat hemophilia patients in China have come to fruition.”

He added that the company would do its best to commercialize it as soon as possible to expand patient access to treatment.

GreenGene F is a third-generation gene recombination-type hemophilia A treatment, launched in 2010 after GC successfully developed it for the third time in the world and for the first time in Korea.