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On December 30, 2025, Imbioray's ACC-NK (IBR854) achieved another milestone breakthrough! The Phase II clinical trial project of Imbioray’s IBR854 Cell Injection combined with pemetrexed and cisplatin for the first-line treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Acceptance Nos.: CXSL2501161, CXSL2501162).This is another Phase II clinical trial project accepted by the National Medical Products Administration (NMPA) following the April 18 of this year, when Imbioray's ACC-NK (IBR854) for the treatment of advanced renal cell carcinoma received tacit approval from the NMPA for clinical trials.The Phase II clinical trial of Imbioray's IBR854 cell injection for the treatment of advanced renal cell carcinoma has been fully launched this August, led by Professor Dingwei Ye from the Fudan University-affiliated Cancer Hospital.The Phase II clinical trial project recently approved for acceptance focuses on first-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer, representing another significant layout by Imbioray in the field of cell therapy. As a subtype of lung cancer with a very high prevalence, non-squamous non-small cell lung cancer affects a large patient population with urgent clinical treatment needs. While traditional chemotherapy regimens can extend survival to some extent, challenges such as efficacy bottlenecks and drug resistance remain, highlighting the pressing need for better therapeutic approaches.As of now, in the field of immune cell therapy, Imbioray is far ahead in both the number of clinical trial projects searchable on the official website of the National Medical Products Administration and the progress of clinical trial projects.In the field of cell therapy, gene editing technology used to be the mainstream direction, but the potential safety risks that came with it have always constrained the development of cell therapy.Imbioray's ACC-NK adopts non-viral vectors, no gene editing, and an "ADC approach" of antibody conjugation technology to covalently link a specific antibody targeting tumor antigen 5T4 with allogeneic NK cells. This achieves "precise targeting" of solid tumor cells while completely avoiding the risk of mutations associated with genetic modifications.As an innovative pioneer in China's cell therapy field, Imbioray has always aimed to tackle clinically challenging tumors and has been continuously advancing the research and clinical translation of innovative drugs. Based on its proprietary antibody-conjugated NK cell platform technology, it has developed several universal off-the-shelf cell therapy products, including IBR854, IBR733, and IBR822.Currently, IBR854 cell injection, the world's first innovative drug for advanced solid tumors, has entered Phase II clinical trials in August 2025, with 8 cases already enrolled. IBR733 cell injection, the world’s first treatment targeting acute myeloid leukemia, has completed Phase I clinical trials. IBR822 cell injection, the first drug targeting Trop-2 for advanced solid tumors, is expected to enter Phase II clinical trials by the end of 2025. IBR900, imbioray's fourth off-the-shelf universal NK cell product to receive CDE's tacit clinical approval, focuses on patients aged 65 and above with B-cell lymphoma or those who are intolerant to or have failed existing treatments, and entered Phase I clinical trials on July 1, 2025. imbioray also has multiple NK cell products at various stages of development.Source: imbioray Bio
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