https://www.prnewswire.com/news-releases/evive-biotech-meets-primary-and-secondary-endpoints-in-global-phase-iii-clinical-trial-for-their-novel-chemotherapy-induced-neutropenia-treatment-301089142.html?utm_source=STAT+Newsletters&utm_campaign=aa45630b7d-stat_china_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-aa45630b7d-149692869

With a Phase 3 win, Evive's lead drug poised to take on Amgen

Evive Biotech is one step closer to getting its first drug approved after clearing a global Phase 3 study for F-627, its lead product designed for breast cancer patients with chemotherapy-induced neutropenia.

This also brings the company one step closer to taking market share from Amgen's Neulasta (pegfilgrastim), the current standard of care for this condition.

The Shanghai-based biologics manufacturer, which changed its name from Generon Biomed in late June, saw F-627 beat primary and secondary endpoints in its clinical trial, which pitted the novel neutropenia therapy against Neulasta.

The study showed that F-627 is as effective as Amgen's therapy in boosting the production of white blood cells and offers another option for patients who cannot use Neulasta.

"F-627's fusion protein structure presents a unique alternative as it reduces the possibility of allergic reactions caused by the PEGylation used in pegfilgrastim," Evive's chief medical officer, William Daley, said in a statement.

The company said it will submit F-627 to the U.S. Food and Drug Administration for approval and explore commercialization partnerships in the U.S., Europe, Japan, China, and other countries.