February 28, 2022, Beijing – Evive Biotech (“Evive”), a global biopharmaceutical company developing novel biologic therapies, announced that the Chinese National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for F-627 (efbemalenograstim alfa) for the treatment of chemotherapy-induced neutropenia (CIN).

Along with the successful submission of BLA to FDA in March 2021, and MAA to EMA in October, the NDA is supported by data from three pivotal phase III trials. All three trials met their primary and secondary endpoints, demonstrating desirable efficacy and safety profile of F-627.

About Ryzneuta™

Ryzneuta™ (efbemalenograstim alfa) is developed for the treatment of chemotherapy-induces neutropenia (CIN) in cancer patients after chemotherapy. Neutropenia is a common side-effect of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cell that fights infection. 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. Ryzneuta™ strengthens the immune system’s ability to fight infection by increasing the production of neutrophils, preventing potential chemotherapy dose reductions and delays that may compromise treatment outcomes. The three Ryzneuta™ pivotal trials are all multi-center, randomized, multi-dose, active-controlled study comparing the efficacy and safety of Ryzneuta™.

About Evive Biotech

Evive Biotech is a global biopharmaceutical company devoted to 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, inflammatory and metabolic diseases. Founded in 2004, we currently have operations in the US, Singapore, and China. As the first biopharmaceutical company to build a platform bringing innovative therapies from China to the world, Evive adopts a holistic approach to drug development, combining exceptional research and commercialization capabilities with our world-class in-house regulatory expertise and extensive international management experience. Through partnerships with industry, physicians, and regulatory authorities, we strive to bring revolutionary remedies to the global market quickly and efficiently to address unmet medical needs, making a real and lasting difference to patients and their families worldwide.

To learn more about Evive Biotech, visit www.evivebiotech.com.