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Jan 06, 2020

Evive Successfully Concludes China Phase III Clinical Trial of F-627 for Chemotherapy-induced Neutropenia

F-627 demonstrates positive results by meeting its primary endpoint
Jan 06, 2020, Shanghai, China — Evive Biotech, an innovative biotech company developing novel biological therapeutics, today announced that its pivotal Phase III study in China for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met its primary endpoint. F-627 is a dimeric recombinant human granulocyte colony-stimulating factor (rhG-CSF) IgG-Fc fusion protein that comprises a new class of long-acting G-CSF to manage CIN in cancer patients. F-627 met its non-inferiority primary clinical endpoint versus Recombinant Human Granulocyte Colony Stimulating Factor (GRAN® / NEUPOGEN®) in the first cycle of prophylactic treatment of CIN in subjects with breast cancer receiving chemotherapy. The duration of neutropenia in cycle one in patients treated with F-627 was not statistically different from patients treated with GRAN® (filgrastim).

“Meeting this trial’s non-inferiority and safety endpoints demonstrates that F-627 has the same efficacy and safety as NEUPOGEN® (GRAN®) but with the convenience of NEULASTA®” said Dr. William Daley, Evive’s Chief Medical Officer. He added, “This reinforces F-627’s ability to be a strong first line application as well as a viable alternative for patients contraindicated or refractory to current treatment options.” Successful completion of this trial is a key milestone towards submitting F-627’s BLA application to the CDE. “Observing a trend in study-drug-related treatment emergent adverse events in favor of F-627 in this trial shows promise for this trend to continue in the upcoming readout from F-627’s global pivotal Phase III trial against NEULASTA®” said Dr. Juhong Liu, Evive’s Chief Scientific Officer.

The China pivotal Phase III trial was a multi-center, randomized, open-label, active-controlled study comparing the efficacy and safety of Evive’s dimeric recombinant human granulocyte colony stimulating factor-fc fusion protein (F-627) and recombinant human granulocyte colony stimulating factor (GRAN® / NEUPOGEN®) in the prophylactic treatment of chemotherapy-induced neutropenia in women with breast cancer receiving myelotoxic EC chemotherapy treatment (epirubicin + cyclophosphamide). This trial was conducted specifically for regulatory submission to the Center for Drug Evaluation (CDE) at China’s National Medical Products Administration (NMPA). Separately, F-627’s global development program includes a Phase III placebo-controlled study completed in 2018 and a Phase III NEULASTA® controlled trial expected to read out in 2020 for submissions in the US and Europe.

Chemotherapy-induced Neutropenia (CIN)
CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. Market research indicates that CIN affects more than 8 million people every year with over 2.5 million people affected in China alone. The global CIN market is estimated to be at $6.0 billion with about >85% of patients still on first-generation of rhG-CSFs, and less than 15% of patients using second-generation rhG-CSFs, the pegylated rhG-CSF.

You are now leaving the Evive Biotech website. Evive offers links to other third party websites that may be of interest to our website visitors. When you click on these links you will leave the Evive’s website and will be redirected to another site. These sites are not under the control of Evive Biotech. Click Continue to proceed or Cancel to go back.

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