INIS and Alpha Nuclides Ink Strategic Development and Distribution Deals for China

International Isotopes, Inc. (INIS) and Alpha Nuclide Inc. (AN) have signed a strategic development and distribution agreement to manufacture and distribute INIS's Theranostics and nuclear medicine products in mainland China. Alpha Nuclide, a leading global supplier of alpha-particle emitting radionuclides and a radiopharmaceutical contract research, development, and manufacturing organization (CRDMO), is partnering with INIS, a renowned supplier of medical isotopes and radiopharmaceuticals.

Alpha Nuclide operates from the Hangzhou Bay district and is establishing an advanced facility in Haiyan, Jiaxing, near Shanghai. This facility will house a 30 MeV proton and a 30 MeV alpha beam cyclotron for producing alpha-emitter and positron-emitter radionuclides for theranostic applications, including Astatine-211, Actinium-225, Zirconium-89, Copper-64, and Germanium-68.

The initial phase of the collaboration involves distributing INIS's RadQual™ calibration sources. Future phases will focus on forming a joint venture to register and locally manufacture INIS's Theranostics and Nuclear Medicine Products with the CFDA. The partnership plans to commercialize INIS's radiopharmaceutical Iodine-131, radiochemical API, and theranostics API I-131 for therapeutic applications in China. These products will be manufactured and distributed from AN's facility in Jiaxing. Additionally, AN will supply raw material isotopes for INIS's manufacturing processes.

Iodine-131 is widely used in China for diagnosing and treating thyroid diseases. Currently, Chinese hospitals and pharmacies rely heavily on imports from Europe and the U.S., leading to supply chain challenges. Recognizing this, the National Health Commission, along with other governmental bodies, released the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035) in June 2021. This plan aims to enhance the medical isotope industry, ensuring a stable and independent supply system to support the "Healthy China" initiative.

Yutian Feng, Co-Founder and CEO of Alpha Nuclide, expressed excitement about the collaboration, highlighting the mutual benefits and growth opportunities it presents. He noted that the partnership aligns with AN's strategy in the radiopharmaceutical space and leverages INIS's global reach and expertise.

Shahe Bagerdjian, President and CEO of INIS, echoed these sentiments, emphasizing the potential to enhance regional supply and expand access to radiopharmaceuticals in China. He praised Alpha Nuclide's accomplishments and described the partnership as a pivotal step in INIS's global growth strategy.

Alpha Nuclide specializes in providing medical radioisotopes, including astatine-211, actinium-225, germanium-68, lead-203, and copper-64. They offer contracted research services and manufacturing for clinical trials. Their headquarters in the Hangzhou Bay district features a Level-2 RAM licensed lab with various specialized facilities. They are also developing a Level-1 RAM licensed facility in Haiyan, Jiaxing, equipped with two 30-MeV cyclotrons and a GMP processing facility to supply medical radioisotopes.

Founded in 1995, International Isotopes Inc. is headquartered in Idaho Falls, ID, USA. The company produces a range of radioisotope products, including sodium iodide I-131 for hyperthyroidism and thyroid cancer, calibration standards for nuclear pharmacies and imaging systems, Cobalt-60 sealed source products, and API supply for theranostics clients.