YONGIN, South Korea I August 18, 2014 I Green Cross, a South Korean biopharmaceutical company, announced today that South Korea’s Ministry of Food and Drug Safety has granted marketing authorisation for Neulapeg® (pegteograstim), a treatment for abnormally low level of neutrophils in patient undergoing chemotherapy.

Green Cross anticipates that this approval will be an important boost to further support for the company’s efforts to expand its cancer care products.

Neulapeg® is a long-acting PEGylated recombinant human granulocyte-colony stimulating factor (G-CSF), indicated for the reduction of the duration of neutropenia in patients treated to eliminate solid tumour and malignant lymphoma with cytotoxic chemotherapy. The clinical trials showed non-inferiority of the efficacy and tolerability of Neulapeg®to pegfilgrastim. This new medicine is intended as a fixed once-per-cycle dose, unlike currently marketed 1st generation G-CSF products which require 4 to 6 daily injections following each cycle of chemotherapy.

Neutropenia (a granulocyte disorder characterized by an abnormally low number of neutrophils) is one of the most serious side effects of chemotherapy. Neutropenia can put some patients at risk for severe infections and may cause interruptions in cancer treatment.

“This is a significant milestone for Green Cross as Neulapeg®is the first Green Cross oncology supportive care treatment product.” said Su-Jung Kim, Oncology Team Leader of Green Cross. “Neulapeg® will be available in the Korean market early next year. We are poised to accelerate the introduction of Neulapeg®into foreign markets.”

About Green Cross
Green Cross provides safe and effective healthcare solutions that address the evolving needs of human health. Headquartered in Yongin, South Korea, Green Cross specialises in the development and manufacture of plasma-derivatives, vaccines and recombinant proteins.

SOURCE: Green Cross