GC Green Cross Neutropenia Treatment 'Neurapec' Same-Day Administration Clinical Trial Approved

Purpose of Securing Clinical Evidence for Same-Day Administration of Nurapec After Chemotherapy

GC Green Cross Neutropenia Treatment Newrapec.

[Asia Economy Reporter Lee Gwan-joo] GC Green Cross announced on the 14th that it has received approval from the Ministry of Food and Drug Safety for an investigator-initiated clinical trial plan (IND) on same-day administration of 'Neurapec' after chemotherapy treatment.

Neurapec is a second-generation neutropenia treatment independently developed by GC Green Cross. It increases the half-life compared to existing G-CSF (granulocyte colony-stimulating factor) agents, allowing the drug effect to be maintained longer. This product is administered after chemotherapy to prevent side effects such as fever and infections caused by a decrease in neutrophil counts in the body.

Currently, neutropenia treatments under approved usage must be administered 24 hours after chemotherapy, causing inconvenience for patients who need to extend hospitalization or visit hospitals/clinics the next day. To resolve this, GC Green Cross developed and has been supplying since last year 'Hugpec,' a self-administration support device for Neurapec.

The approved clinical trial aims to provide evidence for cases where same-day administration is inevitably required in medical practice. According to a large-scale retrospective study in the U.S. published in the journal Blood in 2014, despite the approved usage of G-CSF agents, about 13% of patients with solid tumors and hematologic cancers receive G-CSF agents on the same day after chemotherapy.

This study will divide 160 patients with colorectal cancer, pancreatic cancer, and small cell lung cancer into two groups, administering Neurapec on the day of chemotherapy completion (same-day administration) and 24 hours later, respectively, to evaluate the non-inferiority of neutropenia prevention effects. The clinical trial is led by Professor Park Kwon-oh of the Hematology-Oncology Department at Yangsan Pusan National University Hospital, with three researchers from the Palliative Care Division of the Korean Cancer Study Group (KCSG) jointly participating.

Professor Park, the principal investigator, stated, "If the safety of same-day administration of Neurapec is clinically confirmed through this study, the chemotherapy process for patients may become somewhat easier in the future."

Since its launch in 2015, Neurapec's efficacy and safety have been proven in medical practice, leading to a gradual increase in prescriptions. Last year, it accounted for the largest share of 49% (based on IQVIA data) among neutropenia treatments prescribed.

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