Congratulations! YiboRay's IBR733 Cell Injection Receives IND Approval from CDE
iMBioRay
CAR-NK Cell Therapy Drug Developer
Yisheng Bio Important Strategic Partner——Imbioray (Hangzhou) Biopharmaceutical Co., Ltd.Imbioray received the implied permission (acceptance number: CXSL2300643) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in December this year for the clinical trial application (IND) of IBR733 cell injection.
IBR733 Cell Injection is a universal off-the-shelf CAR-raNK cell product derived from allogeneic peripheral blood, primarily used for the treatment of relapsed/refractory acute myeloid leukemia.
In this project, Yusheng Bio provided comprehensive technical services and validation support related to rapid mycoplasma NAT detection. The MycAway™ Mycoplasma qPCR Detection Kit has been fully validated for its specificity, limit of detection, and robustness according to EP 2.6.7 and JP G3. It also covers the types of mycoplasma strains required for validation by USP, WHO, and ChP. The kit’s performance complies with regulatory standards in China and abroad as well as international authoritative organizations, facilitating the smooth acceptance of the project's clinical trial application by the National Medical Products Administration (NMPA).
Imbioray Related Products:
NAT Method | Mycoplasma qPCR Detection and Method Validation
About IBR733 Injection
IBR733 Injection is a globally innovative product independently developed by Imbioray, consisting of a CD33/CLL1 bispecific antibody conjugated with NK cells. Both its product structure and therapeutic approach are internationally pioneering, marking a significant milestone. Results from investigator-initiated clinical trials (IIT) conducted by Imbioray show that IBR733 Injection is highly effective and very safe, offering new hope for AML patients.
About Imbioray
Imbioray is dedicated to addressing the unmet clinical needs in the treatment of tumors and immune-related diseases, primarily focusing on the development of cutting-edge NK cell therapies and cell engager products worldwide. Imbioray has pioneered the international tiNK and CAR-raNK cell technology platforms and possesses advanced proprietary processes for large-scale ex vivo closed-system cultivation of NK cells. Based on its proprietary platform technologies, Imbioray has developed several off-the-shelf cell therapy products such as IBR854 and IBR733. Multiple investigator-initiated clinical trials (IITs) have been conducted, preliminarily demonstrating safety and efficacy. Currently, the IBR854 cell injection has progressed to Phase I clinical trials, with several other novel drugs for solid tumors and hematologic malignancies gradually advancing.
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Yisheng Bio
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Yeasen Biotechnology (Shanghai) Co., Ltd. is a high-tech enterprise focused on the upstream core raw materials of the life science industry chain, engaged in the research, production, and sales of biological reagents in three major categories: molecular, protein, and cell. Core products cover multiple categories including qPCR series, NGS series, reverse transcription series, nucleic acid extraction and purification series, PCR series, molecular cloning series, in vitro transcription series, antibodies, protein purification series, protein analysis series, recombinant proteins, cell analysis series, cell culture series, cell transfection series, and reporter gene detection series. These products are widely used in life science research, diagnostic testing, and biopharmaceutical fields.
