Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta(TM)
BLA submission to the U.S. FDA follows successful conclusion of Evive's Global Phase III Clinical Trial for chemotherapy-induced neutropenia in breast cancer patients.
Evive is the first Chinese biologics company to advance a novel biologic product from pre-clinical studies to a completed BLA submission.
SINGAPORE,March 31,2021 --Evive Biotech,a global biologics company developing novel biologic therapies,today announced the submission of its Biologics License Application (BLA) for Ryzneuta™(also known as F-627) to the US Food & Drug Administration (FDA).The submission follows the successful conclusion of Evive's Global Phase III Clinical Trials (NCT03252431 and NCT02872103),which met its primary and secondary endpoints,demonstrating strong and lasting benefit for patients.
Ryzneuta™is a novel treatment for chemotherapy-induced neutropenia (CIN). Neutropenia is a common side-effect of many forms of chemotherapy and is a condition characterized by low levels of neutrophils,a type of white blood cell that fights infection. Ryzneuta™strengthens the immune system's ability to fight infection by increasing the production of these critical white blood cells,thus preventing potential chemotherapy dose reductions and delays that may compromise treatment outcomes. Due to its novel structure,achieved through Evive's proprietary DiKine™fusion protein platform,Ryzneuta™presents a unique,naturally long-acting,treatment alternative to current pegylated G-CSF treatments.
"This is a significant milestone for Evive and demonstrates our full in-house capability to develop a novel biological drug from laboratory bench to global market launch. We are very proud to be the first Chinese company to submit a completed BLA package and I am delighted that this has been achieved by our own team," said Dr. Jubo Liu,Evive Biotech's CEO. "With this submission,we are looking forward to working with our partners to make Ryzneuta™accessible to patients suffering from chemotherapy-induced neutropenia," he added.
Ryzneuta's global development program,which spans 10 clinical trials and has enrolled over 1,200 patients to date in multiple territories including the US,EU,Australia,and China,has met all primary and secondary endpoints across all its trials. Ryzneuta's global pivotal phase III trial was conducted under a Special Protocol Assessment (SPA) in agreement with the U.S. FDA.
"Neutropenia is a common and potentially life-threatening complication for cancer patients," said Dr. William Dailey,Evive Biotech's Chief Medical Officer. "Submission of our BLA is an important step that brings us closer to providing a strong first-line treatment and an alternative to patients who are contraindicated or refractory to current treatment options. I am very proud of every member of our team that has worked hard to bring us to this point – my congratulations to them."
"There are estimated to be eight million global patients undergoing chemotherapy every year who are at risk of developing CIN," said Dr. John Glaspy,Principle Investigator of the Global Clinical Trial Programand Professor of Medicine at the Jonsson Comprehensive Cancer Center (JCCC) of the University of California,Los Angeles (UCLA) School of Medicine,"and we look forward to working with the FDA to advance Ryzneuta™through the approvals process and to launch it as a new option for patients with this serious condition."
The FDA generally acknowledges its decision to accept or reject an application 60 calendar days after the date of the initial submission. In addition to the BLA submission to the FDA,Evive is working towards submitting a Marketing Authorization Application to the European Medicines Agency and a New Drug Application to China's National Medical Products Administration.
Notes to editors
For further information,please contact:
Brunswick Group
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About Ryzneuta™
Ryzneuta™(efbemalenograstim alfa) is developed for the treatment of chemotherapy-induces neutropenia (CIN) in cancer patients after chemotherapy. Ryzneuta™is a recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal. Ryzneuta™is expressed in Chinese Hamster Ovary (CHO) cells. Ryzneuta™exists as a homodimer with two G-CSF-Fc molecules covalently linked through disulfide bonds formed between the Fc moiety of the molecule. Through specific binding to its receptor,G-CSF receptor,Ryzneuta™stimulates survival,proliferation,differentiation,and function of neutrophil precursors and mature neutrophils.
The Ryzneuta™pivotal Phase III trial (NCT03252431),during which the product was known as F-627,is a multi-center,randomized,multi-dose,active-controlled study comparing the efficacy and safety of Ryzneuta™and Neulasta®. The trial met its primary and secondary endpoints mutually agreed upon by the FDA and Evive during Special Protocol Assessment (SPA). The results demonstrated the efficacy and safety profile of Ryzneuta™.
About Evive Biotech
Evive Biotech is a global biologics company with Asian roots,developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary technology platforms to advance a series of innovative drug candidates for oncology and inflammatory disorders. Founded in 2004,we have over 200 employees today with operations in the US,Singapore and China. We adopt a holistic approach to drug development,combining exceptional research and commercialization capabilities with world class in-house regulatory expertise to bring innovative therapies to market quickly and efficiently. Our state-of-the art in-house cGMP facility allows us to manufacture at commercial scale in accordance with FDA,EMA and NMPA standards and industry best practices. Through partnerships with industry,physicians,and regulatory authorities,we develop revolutionary remedies that we believe will make a real and lasting difference to patients and their families worldwide.
To learn more about Evive Biotech,visit www.evivebiotech.com
