SUZHOU INDUSTRIAL PARK, Feb. 13, 2019 – Suzhou SmartNuclide Biopharmaceutical Co., Ltd. (SmartNuclide Biopharma), a biopharmaceutical company focused on discovering and developing innovative biologics used in nuclear medicine, today announced that the first patient has been treated in Phase 1/2 Clinical Trial of SNA001 for well-differentiated thyroid cancer (DTC), following receiving the Investigational New Drug (IND) approval from National Medical Products Administration of China (NMPA, formerly known as CFDA) in October, 2018.

SNA001, the first approved recombinant human thyrotropin (rhTSH) for clinical trial in Mainland China, is used for manipulating endocrine function of thyroid-derived cells, as part of the diagnosis and treatment of DTC. The trial is carried out at the Department of Nuclear Medicine of Zhongshan Hospital, a major teaching hospital in Shanghai, affiliated with the Shanghai Medical College of Fudan University, with Professor Hongcheng Shi and Professor Xuening Li being the Principle Investigators.

“We are very proud to announce the initiation of the very first clinical trial of rhTSH in Mainland China,” said Dr. Tao Xu, Chief Executive Officer and Chairman of SmartNuclide Biopharma, “As one of the most prestigious clinical departments for the diagnosis and treatment for thyroid cancer across the country, the Nuclear Medicine Department of Zhongshan Hospital assures high quality of the trial.”

“Having been approved for clinical use in the west as early as twenty years ago, rhTSH is commonly used for thyroid cancer patients in almost a hundred countries worldwide nowadays. Unfortunately, patients in our country still do not have access to it until today, leading to unnecessary pains and inconveniences associated with hypothyroidism during their fight with cancer. I anticipate SNA001 will eventually fill this urgent clinical gap.” said Professor Hongcheng Shi, the Head of the Department of Nuclear Medicine of Zhongshan Hospital.

Thyroid cancer is the most incident carcinoma of the endocrine system and the most incident carcinoma among women under 30. Thyroid cancer ranks as the top 10 most incident cancer type in China, with as many as 100 thousand new cases diagnosed annually. More strikingly, the incidence of thyroid cancer has been reported to be rising faster than any other cancer sites in recent years. DTC comprises approximately 90% of all thyroid malignancies.

After thyroidectomy, patients have to take thyroid hormone pills daily, leading to a very low serum thyroid-stimulating hormone (TSH) level. With the ability to elevate serum TSH level safely and fast, rhTSH is used clinically for preparation for radioactive iodine remnant ablation and follow-up monitoring without the need for thyroid hormone withdrawal in patients diagnosed with DTC. Regardless of the fact that China’s 2012 Diagnosis and Treatment Guidelines for Thyroid Nodules and DTC and 2014 Treatment Guidelines of DTC with Iodine-131 both recommended using rhTSH to elevate serum TSH in DTC patients, there is not a single approved rhTSH product available for clinical use in Mainland China up until this very day.

Based in Suzhou Industrial Park, SmartNuclide is a clinical-stage biopharmaceutical company focused on discovering and developing innovative biologics for nuclear medicine, with its world-leading research and development technology platform for domain antibody-radiopharmaceuticals. The company has built a broad yet unique pipeline composed of radiopharmaceuticals for both imaging and therapy and recombinant proteins for nuclear medicine.