International Isotopes, Inc. (INIS) and Alpha Nuclide Inc (AN) have entered into a Strategic Development and Distribution Agreement for the rights to manufacture and distribute INIS's Theranostics and nuclear Medicine Products in mainland China. Alpha Nuclide is a global leading supplier of alpha-particle emitting radionuclides and a radiopharmaceutical CRDMO. INIS is a global supplier of medical isotopes, radiopharmaceuticals, sealed source devices, and medical devices for radioisotopes.
Alpha Nuclide currently operates from Hangzhou Bay district and is setting up a world-class facility with a 30 MeV proton and a 30 MeV alpha beam cyclotron for the production of alpha-emitter and positron-emitter radionuclides for theranostic applications, such as Astatine-211, Actinium-225, Zirconium-89, Copper-64 and Germanium-68, in Haiyan, Jiaxing, China; which is located just outside of Shanghai.
The parties will begin with the distribution of INIS's RadQual™ calibration sources as phase I of the strategic alliance, with further planned milestones for the establishment of a joint venture to register INIS's Theranostics & Nuclear Medicine Products with the CFDA for local manufacturing and distribution. The parties envision commercializing INIS's radiopharmaceutical Iodine-131, radiochemical API, and theranostics API I-131 for 3rd party therapeutic applications in China. The parties intend to manufacture and distribute these the INIS products from AN's Jiaxing facility. The parties also intend to enter into a supply agreement for raw material isotopes to be supplied from Alpha Nuclide and used in INIS's manufacturing process.
I-131 for Thyroid Disease diagnosis and radio-therapy in China represents the majority of all radioisotope uses in China. Currently, hospitals and pharmacies in China are primarily dependent on supply from Europe or the U.S., leading to issues with reliability of service and access to treatment. In June of 2021, the 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). The plan aims to improve the medical isotope industry and related industries to support the "Healthy China" initiative. It also aims to create a stable and independent medical isotope supply system.
"Alpha Nuclide is delighted and excited to partner with INIS in a multifaceted collaboration, connecting the Chinese market with a US company, and vice versa. Our vision for growth in the radiopharmaceutical space is aligned as we focus on the supply of radionuclides and the logistics for manufacture and supply of radiopharmaceuticals. INIS is one of the biggest players in this space, and have a global reach in radiopharmacies and other radiopharmaceutical end users. AN's strategy is complimentary to INIS. This collaboration will be mutually beneficial and bring exciting growth for both parties" said Yutian Feng, Co-Founder and CEO of Alpha Nuclide Inc.
"INIS is proud to partner with Alpha Nuclide to increase regional supply and expand access to radiopharmaceuticals in China. Alpha Nuclide has accomplished a lot in their early years. In my experience in operating the leading radiopharmacy network in China, I see Alpha Nuclide as the perfect multi-dimensional partner to team up with. For us at INIS, this is the next phase of our global growth strategy and we are excited to get the project going" said Shahe Bagerdjian, President and CEO of International Isotopes.
