Tokyo/Shanghai [April 30, 2025] — Evive Biotech Co., Ltd., a clinical-stage biopharmaceutical subsidiary of YIFAN PHARMA, and Japan-based I'rom Group Co., Ltd., one of the largest Site Management Organization in Japan for supporting clinical studies globally and currently focusing on regenerative medicine and vaccine areas, today announced that Evive Biotech and I'rom have commenced cooperation toward development of Evive Biotech’s novel biologic drug Efbemalenograstim alfa injection (internal code: F-627, "Ryzneuta®") in Japan based on the 2024 strategic agreement, and both parties collaborate to commence the design and development of the regiment for a same-day dosing with chemotherapy, that is not suitable for existing G-CSF products, for the Japanese market in the second quarter of this year.

I'rom's decision to work for development of Ryzneuta® is based on the rigorous evaluation of its robust global clinical dataset, including 12 Phase I-III trials, and I’rom’s confidence of its great potential commercial value to address unmet medical needs in Japanese oncology supportive care, as the preclinical data demonstrated Ryzneuta®'s potential of same-day dosing post-chemotherapy, which has been further validated through Investigator-initiated trials (IITs) conducted in China. Its result of the same-day dosing interim analysis was published at the 16th American Association for Cancer Research (AACR) Annual Meeting, showing administration of Ryzneuta® on same-day of chemotherapy was as safe and effective as conventional administration after 24 hours in reducing risk of CIN.

The collaboration marks a strategic milestone to advance Ryzneuta®'s regulatory and commercial trajectory in Japan, leveraging its differentiated molecule structure and manufacture technologies for the prevention of chemotherapy-induced neutropenia (CIN).

 

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Notes for editors

For further information, please contact:

Evive Biotech Media     
media@evivebiotech.com

I’rom Group Media

web-info@iromgp.com

 

About Ryzneuta®
Ryzneuta® (Efbemalenograstim alfa) is developed for the treatment of Chemotherapy-Induced 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 disulphide 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 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

Evive Biotech, a subsidiary of Yifan Pharmaceutical, 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.

 

About I’rom Group

I'rom Group is four business units (Advanced Medicinal Treatment Services, Site Management Organization (SMO) Services, Contract Research Organization (CRO) Services, and Medical Support Services) contribute at various stages to ensure that pharmaceuticals and medical technologies get to the patients that need them. In its core business unit SMO, I'rom Group collaborates with medical institutions throughout Japan and its highly qualified CRCs (Clinical Research Coordinator) work with doctors, medical staff, and patients to support pharmaceutical companies conducting various clinical trials. The Advanced Medicinal Treatment business unit engages in the research and development of advanced medicine and regenerative medicine such as development of new vaccines and gene therapy, and the sales of iPS Cell manufacturing tools including Sendai virus vector and CytoTune-iPS kit. Since its formation, I'rom Group has consistently been involved in each of these businesses with the objective of contributing to medical development, to elevate the quality of patients' lives. In future I’rom Group will make further efforts to provide support for clinical trials and for technical developments in advanced medicine. I'rom Group continues to advance, with the strong belief that making new therapeutic technologies available to patients will give them hope for the future.