GreenGeneF, Green Cross's Hemophilia Treatment, Obtains Product Approval in China

GC Green Cross's gene recombinant hemophilia treatment 'Greenzin-F' (Photo by GC Green Cross)

[Asia Economy Reporter Chunhee Lee] GC Green Cross's hemophilia treatment ‘GreenGene F (Berotocog Alfa)’ has received product approval from Chinese health authorities.

Green Cross announced on the 12th that its hemophilia treatment GreenGene F has obtained product approval from the National Medical Products Administration of China. This is the first time a domestically developed recombinant gene therapy hemophilia treatment has received product approval from Chinese authorities.

GreenGene F is a third-generation recombinant gene therapy for hemophilia A. Green Cross successfully developed it as the third in the world and the first in Korea, launching it in 2010. In 2016, Green Cross announced it would halt clinical trials in the U.S. early and focus on the high-growth potential Chinese market, signaling its intention to directly confront development risk controversies.

Through clinical trials in China, Green Cross succeeded in meeting all major evaluation criteria for GreenGene F. For the primary endpoint of hemostasis and bleeding prevention, 80% of patients showed symptom improvement within 8 hours after treatment administration, and the secondary endpoint, the ‘Annual Bleeding/Joint Bleeding Rate,’ improved by approximately 94%.

Only about 40% of all hemophilia A patients in China receive treatment. Compared to other countries with fewer new prescription candidates, the market potential is considered sufficient. In fact, the Chinese hemophilia treatment market is expected to grow to 400 billion KRW by 2028, more than doubling the market size recorded last year.

Local marketing and sales of GreenGene F will be handled by GC China, a local affiliate with the strongest market share in plasma-derived hemophilia treatments in China and a solid sales and distribution network.

Huh Eun-cheol, CEO of GC Green Cross, said, “This approval is the fruition of our ongoing efforts to treat hemophilia patients in China,” adding, “We will do our best to expedite commercialization to expand treatment accessibility for patients.”

This content was produced with the assistance of AI translation services.