Suzhou, China, April 13, 2022 – Suzhou Smart Nuclide (“Smart Nuclide”, “Company”) announces today that the U.S. Food and Drug Administration (“FDA”) cleared the Company’s Investigational New Drug Application (“IND”) for SNA002, which is a self-developed radioactive diagnostic imagining agent labeled by ⁶⁸Ga targeting PD-L1. SNA002 is a PET imaging agent with single-domain antibody as ligand and conjugated with ⁶⁸Ga. It enables physicians to evaluate the PD-L1 expression in primary and/or metastatic lesions in solid tumor patients.

The FDA approval of the IND for SNA002 marks an important milestone towards the industry, which represents a complete path for the IND application to FDA from Chinese innovative nuclear medicine companies. The research and development of Chinese innovative nuclear medicine begins to meet with the international standards, which will encourage other relevant companies. SNA002 is expected to be the first commercialized innovative nuclear medicine in Europe and the United States from China.

SNA002 is a radioactive diagnostic imagining agent labeled by 68Ga targeting PD-L1. SNA002 only takes 1-2 hours to imaging after injection, which can rapidly visualize the PD-L1 expression level of various organs of the whole body in a real-time, dynamic, and accurate basis, including heterogeneous expression in the tumor and micro metastasis, SNA002 can achieve:

• Accurately identifythose patients who are effective to PD-1 treatment, guide patients to accurately use drugs, comply with ethics, improve patients’ life quality, and save patients’ expenses and national health-insurance funds
• It replaces the traditional method of invasive sampling for immunohistochemistry, while reducing the pain of patients, they can have imaging examination at any time according to the stages of the disease.

Today, PD-L1 monoclonal antibody has become the most mature product in the world. According to Frost & Sullivan, the global PD-L1 inhibitor market will reach US $63.9 billion by 2023. In China, this market is expected to reach 66.4 billion RMB in 2023. PD-L1 testing plays a very important role in the accessibility of immune checkpoint inhibitor efficacy prediction and evidence-based medicine. Based on this, PD-L1 testing has been updated into NCCN guidelines and CSCO guidelines for lung cancer. However, PD-L1 immunohistochemistry has limited predictive value, possibly because of tumor heterogeneity of PD-L1 expression. Noninvasive PD-L1 imaging using SNA002 can better reflect tumor PD-L1 expression.

Dr. Xu Tao, Chief Executive Officer & Founder of Smart Nuclide, commented:

“The FDA clearance of the IND application for SNA002 is a significant milestone for Smart Nuclide as we move into clinic with the first ⁶⁸Ga labeled imaging agent through our unique SRC platform. Is proves that the Company has an expertise in the molecular discovery, verification, process development, registration of radiopharmaceutical products, especially based on single-domain antibody as ligand. In the future, there will be more innovative diagnostic option for patients. Meanwhile, this is only the first step for the Company, we look forward to advancing SNA002 from the pre-clinical stage to the clinical stage and finally to commercialization. We also believe other innovative nuclear medicine companies in China can develop quickly benefiting from the favorable national policies and to be competitive internationally.”