GreenGene F, Next-gen Hemophilia A Treatment, Approved in China

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by Teresa Carvalho, MS |

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Kovaltry | Hemophilia News Today | trial top-line data | clotting factor for blood cells

GreenGene F (beroctocog alfa), a lab-made version of coagulation factor VIII, has been approved by regulators in China for the control and prevention, or prophylaxis, of bleeding episodes associated with hemophilia A, the therapy’s developer, GC Pharma,  announced.

GreenGene F will be available in China in the first half of 2022, and marketed in collaboration with the company’s affiliate, GC China.

“The approval of GreenGene F in China marks an important milestone for GC Pharma and supports our ongoing commitment to treating patients living with [this] rare disorder,” EC Huh, PhD, president of GC Pharma, said in a press release.

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Hemophilia is a rare genetic disorder in which the blood fails to clot as it should, leading to excessive bleeding. In hemophilia A, this failure is caused by the lack of factor VIII. Current treatments aim at providing the missing factor VIII to patients to prevent spontaneous bleeding and damage to joints.

GreenGene F’s approval by China’s National Medical Products Administration (NMPA) was based on a Phase 3 clinical trial in that country, which showed the therapy’s efficacy in easing symptoms in about 80% of hemophilia A patients, GC Pharma, based in Korea, reported in its release.

Within eight hours of a single injection, the treatment stopped or prevented bleeding, meeting the trial’s primary endpoints. The study also achieved key secondary goals, with GreenGene F effectively showing a 94% reduction in annual bleeding rates — the number of spontaneous bleeding events over a year — and annual joint bleeding rates.

Patients treated with GreenGene F in the trial also reported a better quality of life, the release stated. Researchers reported no serious adverse events associated with the treatment.

GreenGene F  is a third-generation recombinant factor VIII, GC Pharma reported on its website, and “offers a significantly reduced risk of transmission of viral pathogens.”

After halting a U.S.-based clinical trial program (NCT01568580NCT01619046, and NCT02027779) into the therapy, the company focused on the hemophilia patients in China, citing greater market growth potential.

According to GC Pharma, about 60% of the people with hemophilia A in that country are not being treated properly or not using any disease-specific treatment.

GreenGene F was approved in Korea to treat hemophilia A in 2010.