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〜Driving Technology Transfer and Test Manufacturing Following Regulatory Approval to Launch Company-Led af-001 Trial〜
TOKYO, Oct. 8, 2025 /PRNewswire/ -- Alpha Fusion Inc. (Alpha Fusion) is proud to announce a joint initiative with the Kobe City Medical Center General Hospital (KCGH) to establish a domestic supply system for investigational drugs utilizing Astatine-211 (At-211). This collaboration significantly advances the foundational work for what is expected to be the world's first company-sponsored clinical trial using At-211 (as of September 2025).
KCGH has secured usage approval for At-211 from Nuclear Regulation Authority. The hospital is now proceeding with technology transfer and test manufacturing of the investigational drug for Alpha Fusion's lead pipeline, af-001 (targeting differentiated thyroid cancer), in preparation for clinical trial initiation. This pioneering effort is setting up a system to seamlessly translate At-211 drug discovery into clinical practice.
Pioneering the World's First Company-Led At-211 Investigational Drug Supply Chain
At-211 is recognized as an exceptionally promising radionuclide for targeted alpha therapy due to its short half-life (approx. 7.2 hours) and simple decay properties. However, a stable supply system for the investigational drug has been a major global hurdle, resulting in all clinical trials to date being academia-led.
In a breakthrough, the partnership with KCGH has established the crucial supply chain necessary to conduct clinical trials in Japan. KCGH operates a radioactive investigational drug GMP manufacturing facility. The hospital's extensive experience in manufacturing investigational drugs using short-lived radionuclides for PET (Positron Emission Tomography) will be adapted for At-211 formulations. Establishing this supply system represents a landmark achievement for global therapeutic development using At-211.
Alpha Fusion has already formed a network with Japanese academic cyclotron facilities capable of At-211 production. By incorporating the hospital's GMP manufacturing facility into the system, Alpha Fusion is building the world's first multi-site supply chain for an At-211 radiopharmaceutical, connecting radionuclide production, drug manufacturing, and clinical trial sites.
af-001: The Lead Pipeline Harnessing At-211's Unique Properties
Utilizing the collaborative framework with KCGH, Alpha Fusion is preparing to launch its first company-led trial with its lead pipeline, af-001. This program targets differentiated thyroid cancer. It exploits At-211's unique property—shared with iodine—of being taken up by the Sodium-Iodide Symporter (NIS), allowing the drug to selectively accumulate in cancer cells. This specific approach is only feasible with At-211 among alpha-emitting radionuclides. Furthermore, the low surrounding radiation risk associated with At-211 is expected to allow for outpatient treatment, offering a powerful and highly convenient new therapeutic option for thyroid cancer patients.
This advancement solidifies the company's leading global position as a "clinical-stage At-211 drug discovery company".
Comment from Sunao Fujioka, CEO of Alpha Fusion:
"Targeted alpha therapy with At-211 could become a new cornerstone of cancer treatment, yet supply has been the global bottleneck. By partnering with KCGH to launch this investigational drug supply system, we have solved this key challenge ahead of the world, marking a giant leap toward clinical implementation. We are accelerating both our clinical development and supply efforts to deliver this new treatment to patients as quickly as possible."
Comment from Tomohiko Yamane, Director of Department of Molecular Imaging Research, KCGH:
KCGH has, over the past decade, manufactured in-house investigational PET diagnostic radiopharmaceuticals, supporting numerous clinical trials, including those for Alzheimer's disease treatments. In recent years, the use of radiopharmaceuticals has expanded from diagnostics to cancer treatment. We regard our participation in Alpha Fusion's company-led trial as a significant step forward in applying our manufacturing and quality-control expertise in radiopharmaceuticals to therapeutic applications. From Kobe, we are committed to delivering new treatment options to patients in our community and around the world as swift as possible."
Future Outlook
The valuable expertise gained by Alpha Fusion in technology transfer, investigational drug manufacturing, and logistics for At-211 therapeutics can be applied to future overseas clinical trials and commercial supply chain design. The successful system established in Japan will serve as a model case for replication and expansion in international markets, starting with the U.S. We are already in active discussions with domestic and international partners to manage these future supply chains.
Alpha Fusion plans to launch the clinical development of multiple At-211 pipelines both domestically and internationally, beginning with af-001. With the domestic investigational drug supply system now in place, we will accelerate the international rollout of At-211 drug discovery, aiming to create medicines for patients currently without treatment options.
〜Driving Technology Transfer and Test Manufacturing Following Regulatory Approval to Launch Company-Led af-001 Trial〜
TOKYO, Oct. 8, 2025 /PRNewswire/ -- Alpha Fusion Inc. (Alpha Fusion) is proud to announce a joint initiative with the Kobe City Medical Center General Hospital (KCGH) to establish a domestic supply system for investigational drugs utilizing Astatine-211 (At-211). This collaboration significantly advances the foundational work for what is expected to be the world's first company-sponsored clinical trial using At-211 (as of September 2025).
KCGH has secured usage approval for At-211 from Nuclear Regulation Authority. The hospital is now proceeding with technology transfer and test manufacturing of the investigational drug for Alpha Fusion's lead pipeline, af-001 (targeting differentiated thyroid cancer), in preparation for clinical trial initiation. This pioneering effort is setting up a system to seamlessly translate At-211 drug discovery into clinical practice.
Pioneering the World's First Company-Led At-211 Investigational Drug Supply Chain
At-211 is recognized as an exceptionally promising radionuclide for targeted alpha therapy due to its short half-life (approx. 7.2 hours) and simple decay properties. However, a stable supply system for the investigational drug has been a major global hurdle, resulting in all clinical trials to date being academia-led.
In a breakthrough, the partnership with KCGH has established the crucial supply chain necessary to conduct clinical trials in Japan. KCGH operates a radioactive investigational drug GMP manufacturing facility. The hospital's extensive experience in manufacturing investigational drugs using short-lived radionuclides for PET (Positron Emission Tomography) will be adapted for At-211 formulations. Establishing this supply system represents a landmark achievement for global therapeutic development using At-211.
Alpha Fusion has already formed a network with Japanese academic cyclotron facilities capable of At-211 production. By incorporating the hospital's GMP manufacturing facility into the system, Alpha Fusion is building the world's first multi-site supply chain for an At-211 radiopharmaceutical, connecting radionuclide production, drug manufacturing, and clinical trial sites.
af-001: The Lead Pipeline Harnessing At-211's Unique Properties
Utilizing the collaborative framework with KCGH, Alpha Fusion is preparing to launch its first company-led trial with its lead pipeline, af-001. This program targets differentiated thyroid cancer. It exploits At-211's unique property—shared with iodine—of being taken up by the Sodium-Iodide Symporter (NIS), allowing the drug to selectively accumulate in cancer cells. This specific approach is only feasible with At-211 among alpha-emitting radionuclides. Furthermore, the low surrounding radiation risk associated with At-211 is expected to allow for outpatient treatment, offering a powerful and highly convenient new therapeutic option for thyroid cancer patients.
This advancement solidifies the company's leading global position as a "clinical-stage At-211 drug discovery company".
Comment from Sunao Fujioka, CEO of Alpha Fusion:
"Targeted alpha therapy with At-211 could become a new cornerstone of cancer treatment, yet supply has been the global bottleneck. By partnering with KCGH to launch this investigational drug supply system, we have solved this key challenge ahead of the world, marking a giant leap toward clinical implementation. We are accelerating both our clinical development and supply efforts to deliver this new treatment to patients as quickly as possible."
Comment from Tomohiko Yamane, Director of Department of Molecular Imaging Research, KCGH:
KCGH has, over the past decade, manufactured in-house investigational PET diagnostic radiopharmaceuticals, supporting numerous clinical trials, including those for Alzheimer's disease treatments. In recent years, the use of radiopharmaceuticals has expanded from diagnostics to cancer treatment. We regard our participation in Alpha Fusion's company-led trial as a significant step forward in applying our manufacturing and quality-control expertise in radiopharmaceuticals to therapeutic applications. From Kobe, we are committed to delivering new treatment options to patients in our community and around the world as swift as possible."
Future Outlook
The valuable expertise gained by Alpha Fusion in technology transfer, investigational drug manufacturing, and logistics for At-211 therapeutics can be applied to future overseas clinical trials and commercial supply chain design. The successful system established in Japan will serve as a model case for replication and expansion in international markets, starting with the U.S. We are already in active discussions with domestic and international partners to manage these future supply chains.
Alpha Fusion plans to launch the clinical development of multiple At-211 pipelines both domestically and internationally, beginning with af-001. With the domestic investigational drug supply system now in place, we will accelerate the international rollout of At-211 drug discovery, aiming to create medicines for patients currently without treatment options.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Alpha Fusion and Kobe City Medical Center General Hospital Establish At-211 Investigational Drug Supply System
Alpha Fusion and Kobe City Medical Center General Hospital Establish At-211 Investigational Drug Supply System
DAVOS, Switzerland, Jan. 24, 2026 /PRNewswire/ -- Leading The Charge – Turning risk into reward with a circular economy for EV batteries and critical minerals, a whitepaper released by the Ellen MacArthur Foundation during the World Economic Forum Annual Meeting 2026, marks the first integrated, actionable circular value-chain roadmap for EV batteries grounded in real-world industrial practice. It also sets a landmark milestone in the cooperation between CATL and the Foundation.
Developed with input from over 30 leading organizations across the EV battery ecosystem — including CATL, DHL, Volvo, and JLR, alongside research institutions and NGOs — the report sets out a clear, industry-informed direction for how EV batteries must be designed, used, recovered, and reintegrated to maximise value and reduce systemic risk across the value chain.
As the founding strategic partner of The Foundation's Critical Minerals Mission, CATL worked closely with The Foundation and industry peers to translate circular economy principles into practical, deployable actions grounded in real operating experience. The roadmap also supports CATL's Global Energy Circularity Commitment, including its long-term goal to decouple battery growth from virgin raw material extraction.
It highlights the opportunities a circular EV battery system can unlock across environment, economy, product, and broader value creation. By keeping batteries and their critical minerals in use across multiple lifecycles, it reduces demand for newly mined materials, lowers emissions, and supports renewable energy integration. It also increases economic value by improving material efficiency, lowering waste and operational costs, and creating new revenue streams. At the same time, it strengthens supply chain resilience and distributes economic benefits more equitably across regions, showing that a systemic, circular approach transforms potential risks into strategic, value-generating opportunities.
Five bright spots to unlock a circular EV battery system
The whitepaper identifies five interdependent actions needed to keep battery materials in high-value use and strengthen system resilience:
CATL actions already in practice
CATL is already putting these system-level actions into practice across its operations. By separating the battery from the vehicle, CATL manages batteries as centrally managed assets, increasing utilization, enabling scheduled maintenance, and ensuring predictable return at end of use. Today, CATL operates more than 1,000 passenger-vehicle and over 300 commercial-vehicle swap stations, supported by a growing ecosystem of more than 100 partners.
This system integration enables high-quality recovery at scale. CATL's recycling operations achieve recovery rates of 99.6% for nickel, cobalt, and manganese, and 96.5% for lithium, with processing capacity expanding toward 270,000 tonnes per year. In parallel, CATL is applying alternative chemistries such as sodium-ion batteries, using widely available materials and reducing lifecycle carbon emissions per kilowatt-hour by up to 60%, reinforcing circular performance across mobility, swapping, and energy storage applications.
Scaling together
Speaking at The Foundation's Leadership Briefing among CATL Jiang Li, Vice-Chairman and Board Secretary of CATL highlighted: "This report marks a major milestone in the global journey towards a circular battery economy. Circular battery systems must now be scaled across regions, industries, and applications — from EVs to energy storage — and adapted to diverse market contexts."
"As EV adoption accelerates, a circular economy for batteries and critical minerals is no longer optional — it is essential to affordability, resilience, and long-term growth while reducing environmental and social impacts," said Wen-Yu Weng, Executive Leader for Critical Minerals at the Ellen MacArthur Foundation. "EV batteries are strategic assets, and circular approaches are key to retaining their value and ensuring critical minerals never become waste. We welcome CATL's contribution and look forward to continued collaboration to help scale a truly circular battery system and support the wider energy transition."
For CATL, this agenda directly underpins its pathway to carbon neutrality — building on the achievement of carbon neutrality across all its battery plants, and its target to achieve carbon neutrality across the full value chain by 2035.
The launch of the report marks an early milestone in CATL and The Foundation's broader collaboration to accelerate circularity of critical minerals. The next phase will focus on stress-testing these approaches in real-world environments, to understand how design, use, life extension, collection, and recycling loops function together at scale.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
CATL and the Ellen Macarthur Foundation Set Direction for Circular EV Batteries with Landmark Whitepaper
