On July 6, 2026 Chimigen Biomedical, a universal immune initiation therapy independently developed by Kemi Biopharmaceutical (Chengdu) Co., Ltd., received clinical trial approval from the U.S. Food and Drug Administration (FDA) , accelerating the international R&D layout of its pipeline.

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Prostate cancer is a typical "cold tumor ," and existing immunotherapies such as PD-1 have repeatedly failed in phase III clinical trials. How to activate tumor-specific immune responses and transform "cold tumors" into "hot tumors" has become one of the most important unmet clinical needs in this field.

KMV002 is an immunotherapy product independently developed by KemiBio for metastatic castration-resistant prostate cancer, and it is also the company’s first product in the oncology field to enter the clinical research stage. Driven by the company’s core technology platform—SynNeogen—KMV002 achieves highly efficient targeted delivery of FcR-mediated dendritic cells (DCs) through AI-assisted engineering, thereby activating cross-antigen presentation and specific CD8+ T cell immune responses, ultimately achieving the therapeutic goal of treating "cold tumors" of the prostate. In previous studies, KMV002 has shown good therapeutic efficacy and safety in multiple animal models. In the future, the company will actively promote the clinical development of KMV002, rapidly verify its safety and efficacy in humans, and provide a new clinical solution for prostate cancer patients.

(Press release, Chimigen Biomedical, JUL 6, 2026, View Source [SID1234673518])