Alpha Fusion and Kobe Hospital launch At-211 Drug system

Alpha Fusion Inc. has announced a strategic collaboration with Kobe City Medical Center General Hospital (KCGH) to establish a domestic supply system for investigational drugs using Astatine-211 (At-211). This initiative represents a major milestone toward launching what is expected to be the world’s first company-sponsored clinical trial utilizing At-211, a promising radionuclide for targeted alpha therapy.

Under the collaboration, KCGH has received approval from Japan’s Nuclear Regulation Authority to use At-211 and has begun technology transfer and test manufacturing of Alpha Fusion’s lead candidate, af-001, which targets differentiated thyroid cancer. The hospital’s radioactive investigational drug GMP manufacturing facility, renowned for its expertise in handling short-lived radionuclides for PET imaging, will play a central role in producing At-211-based investigational drugs under clinical-grade conditions.

At-211 is regarded as one of the most promising radionuclides for targeted alpha therapy due to its short half-life (approximately 7.2 hours), simple decay profile, and high therapeutic precision. Until now, the lack of a stable supply system has confined all At-211 clinical research to academic settings. By establishing an industry-led At-211 supply chain, Alpha Fusion and KCGH are pioneering a new phase of commercial and clinical translation for alpha radiopharmaceuticals.

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The collaboration integrates Kobe City Medical Center General Hospital (KCGH)’s GMP production with Alpha Fusion’s nationwide network of cyclotron facilities capable of producing At-211, creating the world’s first multi-site At-211 supply chain that connects radionuclide production, investigational drug manufacturing, and clinical trial execution.

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This breakthrough makes Alpha Fusion a global leader in clinical-stage At-211 drug discovery. It also lays the groundwork to expand targeted alpha therapy from thyroid cancer to other solid tumors.