South Korean biopharma company Green Cross said Thursday that it has decided to officially halt US-based clinical trials of its recombinant DNA-based hemophilia treatment GreenGene F to concentrate its resources on the Chinese market.
The firm said that the decision was based on the new direction and strategy that it has set for its global business agenda.
“Given the rising investment costs and burden involved, Green Cross decided to end the clinical trials of GreenGene F in the US,” Green Cross said in a statement. “It reflects our strategy to prioritize markets with bigger potential as well as to minimize investment risks and focus on (them).”
A Green Cross spokesperson also clarified that its decision to halt the US trials is unrelated to the drug’s quality or safety, noting that GreenGene F is already being sold in Korea upon approval from the Drug Ministry in 2010.
Since 2012, the company had been conducting third phase clinical trials in the US to test the safety, efficacy and pharmacokinetics of GreenGene F in patients with severe type A hemophilia, according to the US National Institutes of Health’s Clinical Trials Register.
However, the US clinical trials, which Green Cross had expected would be completed within two to three years, took longer than expected due to the difficulty of recruiting patients diagnosed with the rare disease.
Looking ahead, the Korean drugmaker plans to focus on the ongoing clinical trials of GreenGene F in China, which were approved by the local drug regulator in July and are scheduled for completion in 2018.
In bringing GreenGene F to the Chinese market, the firm plans to make full use of the sales and marketing networks it has built in China from selling its plasma-derived hemophilia treatment GreenMono across the nation.
The current Chinese market for hemophilia drugs is much smaller than that in the US or Europe, but it is geared for sharp growth in the future, as untreated hemophilia patients in China are likely to seek treatment in line with rising living standards, according to a report published by Credit Suisse in June 2015.
The Chinese market for type A hemophilia -- consisting of around 50,000 patients -- is also about three times bigger than that of the US, according to the report titled “China Plasma Products Sector.”
In the long run, Green Cross said it has plans to return to the US market with upgraded hemophilia treatment that has therapeutic effects which last twice as long as existing treatments.
By Sohn Ji-young (
jys@heraldcorp.com)
