Pharma Focus Asia

INIS and Alpha Nuclides Establish Strategic Development and Distribution Agreements for China

Saturday, June 08, 2024

International Isotopes, Inc. (INIS) and Alpha Nuclide Inc. (AN) Form Strategic Partnership for Chinese Market

International Isotopes, Inc. (INIS), a global leader in medical isotopes, radiopharmaceuticals, sealed source devices, and medical devices for radioisotopes, has entered a Strategic Development and Distribution Agreement with Alpha Nuclide Inc. (AN). This partnership grants AN the rights to produce and distribute INIS’s Theranostics and Nuclear Medicine Products in mainland China.

Alpha Nuclide, based in the Hangzhou Bay district, is setting up an advanced facility in Haiyan, Jiaxing, near Shanghai. This facility will be equipped with a 30 MeV proton and a 30 MeV alpha beam cyclotron, enabling the production of alpha-emitter and positron-emitter radionuclides such as Astatine-211, Actinium-225, Zirconium-89, Copper-64, and Germanium-68 for theranostic applications.

The collaboration will begin with the distribution of INIS’s RadQual™ calibration sources. Future phases include establishing a joint venture to register INIS’s Theranostics & Nuclear Medicine Products with the CFDA, enabling local manufacturing and distribution. The partnership plans to commercialize INIS’s Iodine-131 radiopharmaceutical, radiochemical API, and theranostics API I-131 for third-party therapeutic applications in China, all to be produced at AN’s Jiaxing facility. Additionally, they intend to form a supply agreement for raw isotopes, provided by Alpha Nuclide, for use in INIS’s manufacturing processes.

I-131 is predominantly used for diagnosing and treating thyroid disease in China. Currently, Chinese hospitals and pharmacies rely mainly on European or U.S. suppliers, leading to service reliability and access issues. In June 2021, China’s National Health Commission, Ministry of Science and Technology, and six other departments issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), aiming to bolster the medical isotope industry and support the "Healthy China" initiative by establishing a stable and independent medical isotope supply system.

Alpha Nuclide Inc., stated, "We are thrilled to partner with INIS in a multifaceted collaboration, linking the Chinese market with a U.S. company. Our shared vision for growth in the radiopharmaceutical sector focuses on the supply of radionuclides and the logistics of radiopharmaceutical manufacture and supply. INIS, with its global reach, complements our strategy perfectly. This collaboration will be mutually beneficial and drive exciting growth for both parties."

International Isotopes, added, "INIS is excited to partner with Alpha Nuclide to boost regional supply and broaden access to radiopharmaceuticals in China. Alpha Nuclide has made significant strides in their early years. My experience managing the leading radiopharmacy network in China confirms that Alpha Nuclide is an ideal, multi-dimensional partner. This partnership marks the next phase of our global growth strategy, and we are eager to begin."

Alpha Nuclide supplies medical radioisotopes such as Astatine-211, Actinium-225, Germanium-68, Lead-203, and Copper-64. The company also offers contracted research services for radiopharmaceutical development and manufacturing to support clinical trials. Headquartered in the Hangzhou Bay district in Ningbo, Alpha Nuclide operates a Level-2 RAM licensed lab equipped with radioactivity processing labs, radiochemistry labs, a cell culture facility, and a small animal facility. They are also building a Level-1 RAM licensed facility in Haiyan, Jiaxing, featuring two 30-MeV cyclotrons and a GMP processing facility to produce medical radioisotopes and GMP-grade radiopharmaceuticals.



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