National Health Laboratory

The Chinese government has announced that it will allow wholly foreign-owned hospitals to be set up in nine regions, including Beijing, in a bid to attract foreign investment and stimulate the economy to boost the flagging economy. The Ministry of Commerce, the National Health Commission and the State Food and Drug Administration jointly issued a document, deciding to expand the pilot work in the field of biotechnology and wholly owned hospitals. In the field of biotechnology, foreign-invested enterprises will be allowed to engage in human stem cell, gene diagnosis and treatment technology development and technology application in the China (Beijing) Pilot Free Trade Zone, China (Shanghai) Pilot Free Trade Zone, China (Guangdong) Pilot Free Trade Zone and Hainan Free Trade Port. All products registered and approved for production will be available for use throughout the country. In the field of hospitals, we plan to set up wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and the whole island of Hainan (except for traditional Chinese medicine, excluding the acquisition of public hospitals). Specific conditions, requirements and procedures will be notified separately. In recent years, top foreign medical institutions have shown strong interest in the growth of China's high-end medical demand market. For example, Mayo Clinic of the United States has set up its first office in Shanghai United Family Hospital and plans to conduct long-term cooperation with China in joint treatment, international academic exchanges, clinical training and other areas to improve the accessibility of international cutting-edge medical technologies in China. Experts pointed out that China's medical level has made remarkable progress in the past decades, especially in the field of treatment of certain diseases, and China's medical level has become a global leader. Chinese doctors have also accumulated rich experience in treatment. As early as 2014, the National Health and Family Planning Commission and the Ministry of Commerce allowed foreign investors to set up wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Jiangsu, Fujian, Guangdong and Hainan through new facilities or mergers and acquisitions. The approval authority for the establishment of wholly foreign-owned hospitals is delegated to the provincial level, and its establishment and change shall be handled in accordance with relevant laws and regulations. The new policy aims to attract foreign investment, promote high-quality development in China's medical related fields, and better meet the medical and health needs of the people. The new policy does not include mergers and acquisitions of TCM hospitals and public hospitals, and specific conditions, requirements and procedures will be announced soon. In addition, the policy allows companies with foreign investors to engage in the development and application of gene and human stem cell technologies for treatment and diagnosis in pilot free trade zones in Beijing, Shanghai, Guangdong and Hainan. The opening of these sectors comes against a backdrop of growth headwinds in the world's second-largest economy and low confidence among foreign businesses.

In order to strengthen the strict supervision of precursor chemicals, the Ministry of Public Security, the Ministry of Commerce, the National Health Commission, the Ministry of Emergency Management, the General Administration of Customs and the State Medical Products Administration jointly issued an official announcement on August 2, 2024, announcing that as of September 1, 2024. A total of seven substances, including 4-(n-phenylamino) piperidine, are formally included in the management scope of the "Regulations on the Management of Precursor Chemicals" (hereinafter referred to as the "Regulations"), and are included in the schedule of the "Classification and Variety Catalogue of Precursor Chemicals". The seven substances included in the management scope include: 4-(n-phenyl-amino) piperidine, 1-tert-butoxycarbonyl-4 -(n-phenyl-amino) piperidine, n-phenyl-N -(4-piperidyl) propionamide, cannabidiol, 2-methyl-3-phenylglycolic acid and its esters, 3-oxy-2-phenylbutyric acid and its esters, And 2-methyl-3 -[3,4-(methylenedioxy) phenyl] glycidates. According to the notice, the first four of the above seven substances, namely 4-(n-phenylamino) piperidine, 1-tert-butoxy-4 -(n-phenylamino) piperidine, n-phenyl-N -(4-piperidyl) propionamide and cannabidiol, are explicitly classified as Class II precursor chemicals in the Schedule to the Ordinance. For the production, operation, purchase, transportation and import and export activities of these substances, the relevant management provisions of non-drug precursor chemicals must be strictly observed. In particular, although cannabidiol is also classified as category II, its pre-clinical research activities in the medical field need to comply with the specific requirements of Article 10 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances. In addition, the announcement also clarified that 2-methyl-3-phenylglycolic acid and its esters, 3-oxy-2-phenylbutyric acid and its esters, and 2-methyl-3 -[3,4-(methylenedioxy) phenyl] glycolic acid esters are also classified as Class II precursor chemicals, and their related activities also need to follow the management provisions of non-pharmaceutical precursor chemicals.

IDAHO FALLS, Idaho and NINGBO, China, June 7, 2024 /PRNewswire/ -- 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. About Alpha Nuclide Alpha Nuclide is a commercial supplier of medical radioisotopes such as astatine-211, actinium-225, germanium-68, lead-203, copper-64 and etc. Alpha Nuclide also provides contracted research services for the development of radiopharmaceuticals and manufacture services of radiopharmaceuticals to support clinical trials. Alpha Nuclide's headquarter is located in the Hangzhou Bay district in Ningbo, where a Level-2 RAM licensed lab is fully operational and equipped with radioactivity processing labs, radiochemistry labs, a cell culture facility and a small animal facility. Alpha Nuclide is also building a Level-1 RAM licensed facility in Haiyan, Jiaxing, where we plan to install 2 30-MeV cyclotrons along with GMP processing facility to supply medical radioisotopes and manufacture GMP grade radiopharmaceuticals. About International Isotopes Inc. International Isotopes Inc. (INIS), established in 1995, with its headquarters in Idaho Falls, ID, USA, manufactures a wide range of radioisotope-focused products. INIS manufactures and supplies generic sodium iodide I-131 radiopharmaceutical drug product for hyperthyroidism and thyroid cancer. INIS manufactures and distributes a complete line of calibration and reference standards for nuclear pharmacies and SPECT/PET imaging systems as well as industrial calibration standards. The Company also manufactures Cobalt-60 sealed source products and provides contract manufacturing of various drug products as well as radioisotope API supply for 3rd party theranostics clients. International Isotopes Inc. Safe Harbor Statement Certain statements in this press release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements with respect to the Company's future growth expectations. Information contained in such forward-looking statements is based on current expectations and is subject to change. These statements involve a number of risks, uncertainties and other factors that could cause actual results, performance, or achievements of International Isotopes Inc. to be materially different from any future results, performance or achievements of the Company expressed or implied by these forward-looking statements. Other factors, which could materially affect such forward-looking statements, can be found in the Company's filings with the Securities and Exchange Commission at , including its Annual Report on Form 10-K for the year ended December 31, 2023. Investors, potential investors, and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements made herein are only made as of the date of this press release and International Isotopes, Inc. and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. FOR MORE INFORMATION ABOUT INIS, CONTACT: David Drewitz Creative Options Communications Investor and Public Relations [email protected] Phone: 972-814-5723 FOR MORE INFORMATION ABOUT ALPHA NUCLIDES, CONTACT: Weibin Zhuo VP & Co-founder +86 189 0220 7829 [email protected] SOURCE International Isotopes Inc.