Evive Biotech and APOGEPHA announce the launch of Ryzneuta® in Germany, the first oversea market launched under Ryzneuta® 's globalization plan

Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., and APOGEPHA Arzneimittel GmbH (APOGEPHA), a Dresden based specialty pharmaceutical company, with a strong focus on innovative therapies announce that the new drug Ryzneuta® is now available in the German market on 7th October 2024. This milestone allows patients under chemotherapy in Germany to receive the first non-pegylated long-acting G-CSF product Ryzneuta®.

Ryzneuta® is an FDA-, EMA- and NMPA-approved, novel, long-acting and PEG-free recombinant human G-CSF for treatment of chemotherapy-induced neutropenia (CIN). It is an innovative drug developed by Evive that has filed for global marketing authorization for the prevention and treatment of neutropenia in cancer patients following the administration of chemotherapy. Since its inclusion in the “catalog of medicines covered by medical insurance“in 2023, Ryzneuta® has attained remarkable sales in Chinese market.

APOGEPHA Arzneimittel GmbH, serving as a significant collaborator of Evive in the European markets, will be responsible for the commercialization of Ryzneuta® in other EU countries through its extensive network, particularly its promotion capabilities, thereby offering superior choices for the prevention and treatment of neutropenia in cancer patients within the region following the administration of chemotherapy.

The successful completion of the first launch in Europe resulted from the close cooperation and joint efforts of both teams. Both companies are looking forward to bring this product to patients in other European markets.

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Notes for editors

For further information, please contact:

Evive Biotech Media    

media@evivebiotech.com

APOGEPHA Arzneimittel GmbH Media

sliebig@apogepha.de

About Ryzneuta®

Ryzneuta® (Efbemalenograstim alfa) is developed for the treatment of Chemotherapy-Induced Neutropenia (CIN) in cancer patients. Neutropenia is a common side-effect of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cells that fight infections. Ryzneuta® is a recombinant fusion protein consisting of two G-CSF molecules and a human IgG2-Fc fragment. Due to the Fc fragment, Ryzneuta® has a prolonged half-life comparable to other, PEGylated G-CSF products on the market. The expression of the fusion protein is done Chinese Hamster Ovary (CHO) cells, resulting in a mammalian glycosylation pattern. 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 pivotal trials of Ryzneuta® are all multi-center, randomized, multi-dose, active-controlled study comparing the efficacy and safety of the drug.

About Evive Biotech and Yifan Pharma

Evive Biotech, a subsidiary of Yifan Pharma, 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 manufacture and regulatory expertise as well as extensive international management experience. Through partnerships with industry, physicians, and regulatory authorities, we strive to bring revolutionary remedies to the global markets 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.

Yifan Pharmaceutical is an innovative R&D and production company focusing on the pharmaceutical and health sectors. Our vision is to develop innovative drugs with definite clinical values, to help disease-afflicted patients regain health. Currently, we are focusing on four business areas, i.e., biologics, small molecules, synthetic biologics, and special traditional Chinese medicines (TCMs), expanding our product R&D pipelines and innovating drugs for disease treatment to address unmet medical needs.

About APOGEPHA Arzneimittel GmbH

APOGEPHA Arzneimittel GmbH is a family-owned German pharmaceutical company with about 150 employees and has its headquarter in Dresden. The company is specialized in urologic an uro-oncologic indications and has long-lasting experience as well as high expertise in development, marketing, and sales of innovative products. With its highly skilled sales team the company reaches Health Care Professionals with scientific sound information to bring the best treatment options to patients. APOGEPHA’s products are sold in 25 markets worldwide. With Ryzneuta®APOGEPHA enlarges its portfolio in the field of oncology.

For more company information, please visit www.apogepha.com.