NAYA Therapeutics Partners with Alpha Nuclide to Advance Astatine-211 Therapy for Hepatocellular Carcinoma in China
核心洞察
NAYA Therapeutics (搜索) has entered a research and manufacturing partnership with Alpha Nuclide (搜索) to support clinical development of NY-703 (搜索), a GPC3 (搜索)-targeting Astatine-211 (搜索) targeted alpha therapy for hepatocellular carcinoma (搜索).
The collaboration will enable investigator-initiated clinical trials for NY-703 (搜索) in China beginning in 2026, targeting the country's large HCC (搜索) population of over 200,000 new cases annually.
Alpha Nuclide (搜索) will supply Astatine-211 (搜索) from its East China production center near Shanghai, utilizing a first-of-its-kind TR-Alpha cyclotron in their state-of-the-art facility.
NAYA Therapeutics (搜索), a clinical-stage biopharmaceutical company, has announced a strategic research and manufacturing partnership with Alpha Nuclide (搜索) to advance clinical development of its GPC3 (搜索)-targeting Astatine-211 (搜索) targeted alpha therapy NY-703 (搜索) for hepatocellular carcinoma (搜索) (HCC (搜索)) in China. The collaboration positions NAYA to initiate investigator-initiated clinical trials in 2026, leveraging China's substantial HCC patient population of over 200,000 new cases annually.
Strategic Partnership for Alpha Therapy Development
Under the agreement, Alpha Nuclide (搜索) will supply Astatine-211 (搜索) (²¹¹At (搜索)) to NAYA Therapeutics (搜索) from its East China production center near Shanghai, where a first-of-its-kind TR-Alpha cyclotron has been installed in the state-of-the-art facility. The partnership underscores Alpha Nuclide's mission to make ²¹¹At accessible for radiopharmaceutical innovators globally through its integrated CDMO service model.
"We are excited to partner with Alpha Nuclide (搜索), a leader in Astatine-211 (搜索) research and manufacturing," commented NAYA CEO Dr. Daniel Teper. "Their growing facilities and deep understanding of the precision manufacturing and supply chain logistics for Astatine-211 makes them an ideal partner for advancing our programs. Access to the China market and its large HCC (搜索) population is critical to accelerating initial data readouts for NY-703 (搜索) prior to expanding development to patients in the US and Europe."
Addressing Critical Unmet Need in HCC Treatment
NY-703 (搜索) represents a novel approach to treating residual disease and metastasis in hepatocellular carcinoma (搜索), consisting of a GPC3 (搜索)-antibody fragment F(ab')2 conjugated to an Astatine-211 (搜索) isotope. The therapy targets a significant clinical challenge, as up to 75% of HCC (搜索) patients treated with surgery and/or immunotherapy relapse within 5 years, often due to the presence of metastases (搜索) and minimal residual disease (搜索) (MRD).
HCC (搜索) represents a rapidly-growing cancer (搜索) with an estimated one million new patients annually worldwide. The partnership with Alpha Nuclide (搜索) provides NAYA with access to China's particularly large local HCC population and enables options to scale patient recruitment as part of a global development plan.
Astatine-211 as Optimal Alpha-Particle Emitter
Dr. Yutian Feng, CEO of Alpha Nuclide (搜索), emphasized the therapeutic potential of the collaboration: "Astatine-211 (搜索) is increasingly recognized as an optimal, 'goldilocks' alpha-particle emitter with highly-attractive properties including a short half-life, clean decay, minimal toxicity, and potential for broad supply, overcoming the limitations over other radionuclides and unlocking the potential of alpha therapies to address the needs of cancer (搜索) patients at risk of residual disease & metastasis."
Alpha Nuclide (搜索) continues to expand its targeted alpha therapy infrastructure, having initiated a second facility in Shijiazhuang City near Beijing to build its fully integrated TAT capabilities.
Building Comprehensive Supply Network
The Alpha Nuclide (搜索) collaboration follows two other recent partnerships with Ionetix (搜索) and Atley Solutions (搜索) as NAYA consolidates critical components to establish a decentralized ²¹¹At (搜索) supply network and maintain its early mover advantage in the targeted alpha therapy space.
NAYA's pipeline harnesses two synergistic modalities: Astatine-211 (搜索) targeted alpha therapies and NK cell engaging bifunctional antibodies, with an initial focus on hepatocellular carcinoma (搜索). The company aims to unlock deeper, more durable responses in patients not responding to current standard-of-care treatments.
Alpha Nuclide (搜索) provides comprehensive radiopharmaceutical manufacturing services in China, with core expertise in cyclotron-based production, TAT drug discovery services, GMP compliance, and clinical logistics, supporting biopharma partners from early-stage research through commercial supply.