According to information publicly disclosed by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), the clinical trial application for Biokin Pharma's first Antibody-Radionuclide Conjugate (ARC), Lutetium [177Lu]-BL-ARC001 Injection, has received implicit approval. The drug is intended for patients with locally advanced or metastatic solid tumors, including but not limited to those who have failed standard therapy or for whom standard therapy is unavailable.
Entrusted by Biokin Pharma, InnoStar conducted comprehensive non-clinical safety evaluations and pharmacokinetic studies for Lutetium [177Lu]-BL-ARC001 Injection. These services were performed in its GLP laboratory, which complies with standards set by the NMPA, FDA, and OECD, and were carried out in accordance with guidelines from the NMPA, ICH, and FDA. InnoStar's professional team ensured the reliability and integrity of the experimental data through a scientifically rigorous approach and highly efficient, precise technical operations. This provided critical data support for the successful clinical approval of Lutetium [177Lu]-BL-ARC001 Injection, accelerating the project's progress.
Lutetium [177Lu]-BL-ARC001 utilizes antibody-mediated targeted delivery technology combined with the potent tumor-killing capability of radionuclides. Compared to traditional radionuclide conjugates, it demonstrates stronger target specificity, higher tumor enrichment, and is expected to show improved efficacy against resistant tumors. This drug is the first Category 1 innovative drug developed by Biokin Pharma from its proprietary HIRE-ARC platform in the ARC field. It is also a potential global first-in-class ARC drug for which the company holds full intellectual property rights.