
"177Lu-BRP-010030 Injection," developed by SuzhouBoomRay Chuanghe Pharmaceutical Co., Ltd. (hereinafter "BoomRay"), has recently obtained implicit approval for clinical trials (Acceptance No. CXHL2501096) from the National Medical Products Administration (NMPA) in China. The drug is intended for the treatment of advanced solid tumors positive for Fibroblast Activation Protein (FAP). It is globally the first and only therapeutic radiopharmaceutical based on a targeted covalent technology to receive such approval.
InnoStar was commissioned by BoomRay to provide comprehensive non-clinical safety evaluation and pharmacokinetic studies for "177Lu-BRP-010030 Injection." Conducted in full compliance with NMPA, ICH, and FDA guidelines within GLP laboratory environments meeting both NMPA and FDA standards, InnoStar's professional team contributed to the successful approval and advancement of the drug into clinical trials through rigorous scientific approach and efficient, precise technical execution.
About CTR-FAPI
CTR-FAPI (BRP-010) is a highly differentiated novel theranostic agent targeting Fibroblast Activation Protein (FAP). Developed using proprietary Covalent Targeted Radioligand (CTR) technology, it is currently the world's only covalent radiopharmaceutical in clinical development for both diagnosis and treatment of FAP-positive solid tumors. CTR-FAPI achieves irreversible covalent binding to the target protein via "SuFEx" modification. Consistent data from preclinical studies and early clinical trials demonstrate that CTR-FAPI offers higher tumor uptake, superior imaging contrast, longer tumor retention, and greater therapeutic potential.
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