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          智核生物獲NMPA首個重組人促甲狀腺素(rhTSH)臨床試驗批件

          時間:2018-10-22 文章來源: 智核生物 打印 字號:



          中國蘇州工業園區,2018年10月22日——蘇州智核生物醫藥科技有限公司(簡稱“智核生物”)是一家專注於核醫學診療生物藥開發與應用的創新型生物醫藥公司。公司於今日宣布,其在研產品重組人促甲狀腺素SNA-001獲得了中國國家藥品監督管理局(NMPA)頒發的藥物臨床試驗批件。


          rhTSH藥物在臨床核醫學科用於分化型甲狀腺癌碘治療前準備與隨訪複查檢測,在國內尚無同品種上市或同類臨床批件,臨床上無藥可用。智核生物SNA-001有望成為中國大陸首個rhTSH藥物。


          “全體員工非常振奮的獲悉SNA-001獲取臨床試驗批件,” 智核生物首席執行官兼總裁須濤博士說:“這是中國大陸首個rhTSH類藥物的批件,同時該批件對我們來說也是一個非常的重要的裏程碑,意味著智核生物由臨床前研究階段邁入了臨床階段,我們的全球化團隊很高興能將這一重要藥物帶給中國廣大的甲狀腺腫瘤患者。”


          rhTSH是國際上甲狀腺癌治療前準備的重要藥品,是保證治療質量的可靠保障,” 中華核醫學會全國委員會前任主委、中國醫科大學附屬第一醫院核醫學科主任李亞明教授表示,“我國甲狀腺癌發病率仍呈上升趨勢,每年甲狀腺切除術後放射性核素碘–131治療近10萬人次。期盼SNA-001早日進入臨床醫療,減輕和避免病人治療過程中甲減的痛苦和風險,提高治療的質量和療效。期待SNA-001項目工作順利開展和推進,早日填補國內空白。”



          關於SNA-001

          SNA-001是一種重組人促甲狀腺素類藥物,可安全並快速提升人體血清促甲狀腺素水平,極大減輕患者治療過程中的痛苦,在分化型甲狀腺癌碘治療前準備與隨訪複查檢測中均有著重要的臨床應用價值。中美相關臨床指南均強力推薦使用 rhTSH藥物做為分化甲狀腺癌治療過程中停用甲狀腺素的取代療法。


          中國每年新發甲狀腺癌約10萬人,且近年來迅速增長,但大陸地區至今無任何一個rhTSH類藥物上市,市場完全空白,醫生與病人無藥可用。智核生物SNA-001有望成為中國大陸首個rhTSH藥物,上市後將產生巨大的社會效益及經濟效益。



          關於智核生物

          智核生物於2015年由蘇州ag亚集徐霆博士發起成立,位於蘇州工業園區,是一家專注核醫學診療藥物研發與應用的創新型醫藥公司,擁有全球領先的納米抗體-核素藥物研發平台技術。公司自成立以來已獲得兩輪共數千萬元人民幣投資,投資方包括薄荷天使基金、沃生投資、翼樸資本和隆門資本。




          SmartNuclide Receives NMPA's 

          First IND Approval for Recombinant Human TSH 


          SUZHOU INDUSTRIAL PARK, October 22, 2018 – Suzhou SmartNuclide Biopharmaceutical Co., Ltd. (SmartNuclide), a biopharmaceutical company focused on discovering and developing innovative biologics used in clinical 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 SNA-001, 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 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 biopharmaceutical product to thyroid cancer patients in China.”


          “As an important drug for the preparation for radioactive iodine remnant ablation, SNA-001’s IND clearance is absolutely revolutionary. Although as many as approximately 100 thousand new cases of thyroid cancer occur in this country annually, there is not even a single rhTSH product available clinically. Without rhTSH, our patients suffer from hypothyroidism caused by the withdrawal of thyroid hormones, a quite painful process both physically and mentally. 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 SNA-001 could fill the gap in thyroid cancer treatment in our country 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.





          About SNA-001

          SNA-001, 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 an alternative to thyroid hormone withdrawal in the treatment of differentiated thyroid cancer. 


          About 100 thousand new cases of thyroid cancer occur in China every year, recognized as one of the most rapidly increasing cancer site. Nonetheless, there is not any approved rhTSH products available for clinical use in Mainland China. Likely to become the first rhTSH product of Mainland China, SNA-001 is expected to generate huge economic returns and social benefits. 



          About SmartNuclide

          Founded in 2015 in Suzhou Industrial Park by Dr. Ting Xu of Suzhou Alphamab, 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. 



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