SUZHOU INDUSTRIAL PARK, Oct. 18, 2018 – Suzhou SmartNuclide Biopharmaceutical Co., Ltd. (SmartNuclide), a biopharmaceutical company focused on discovering and developing innovative biologics used in nuclear medicine, today announced that the National Medical Products Administration of China (NMPA, formerly known as CFDA) has approved the company’s Investigational New Drug (IND) application to initiate the clinical trials for SNA001, the first approval for recombinant human thyroid-stimulating hormone (rhTSH) in Mainland China, for manipulating endocrine function of thyroid-derived cells, as part of the diagnosis and treatment of well-differentiated thyroid cancer.

“All of our team members are delighted to receive this great news,” said Dr. Tao Xu, Chief Executive Officer and Chairman of SmartNuclide Biopharmaceutical, “not only is this the very first rhTSH IND approval from NMPA, but also it is a key milestone for us as SmartNuclide officially becomes a clinical-stage pharmaceutical company. Our global development team is thrilled to be at the forefront of bringing this crucial pharmaceutical product to thyroid cancer patients in China.”

“As an important drug for the preparation for radioactive iodine remnant ablation, SNA001’s IND clearance is absolutely revolutionary. Although approximately 100 thousand new cases of thyroid cancer occur in this country annually, there is not even a single rhTSH product available. Without rhTSH, our patients suffer from hypothyroidism caused by the withdrawal of thyroid hormones, a quite painful process. The use of rhTSH as replacement to iatrogenic hypothyroidism has been clinically proven to make a huge difference in the lives of patients. I expect SmartNuclide’s SNA001 could fill the gap in thyroid cancer treatment in China in future,” said Professor Yaming Li, the Former President of Chinese Society of Nuclear Medicine and the Chairman of Department of Nuclear Medicine of The First Affiliated Hospital of China Medical University.

SNA001, a recombinant rhTSH drug candidate, can elevate the serum TSH level safely and fast. It is used for preparation for radioactive iodine remnant ablation and follow-up monitoring without the need for thyroid hormone withdrawal and symptomatic hypothyroidism in patients diagnosed with well-differentiated thyroid cancer. Based on solid clinical evidence, clinical guidelines of both China and U.S. strongly recommend rhTSH to be used as alternative to thyroid hormone withdrawal in the treatment of differentiated thyroid cancer. To date, there is not any approved rhTSH products available for clinical use in Mainland China. Likely to become the first rhTSH drug product of Mainland China, SNA001 is expected to generate huge economic returns and social benefits.

Founded in 2015 in Suzhou Industrial Park, SmartNuclide is a biopharmaceutical company focused on discovering and developing innovative biologics used in nuclear medicine, with its world-leading research and development technology platform for domain antibody-radiopharmaceuticals. Since inception, the company has raised several tens of millions RMB in two financing rounds from venture investors including Bohe Angel Fund, Watson Capital, Kington Capital, and Longmen Capital.