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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 文章来源: 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”)是一家專注于核醫學診療生物藥開發與應用的創新型生物醫藥公司。公司于今日宣布,其在研産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于分化型甲狀腺癌碘治療前准備與隨訪複查檢測,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有望成爲中國大陸首個rhTSH藥物。


“全体员工非常振奋的获悉SNA-001获取临床试验批件,” 智核生物首席执行官兼总裁须涛博士说:“这是中国大陆首个rhTSH类药物的批件,同时该批件对我们来说也是一个非常的重要的里程碑,意味着智核生物由临床前研究阶段迈入了临床阶段,我们的全球化團隊很高兴能将这一重要药物带给中国广大的甲状腺肿瘤患者。”


rhTSH是国际上甲状腺癌治疗前准备的重要药品,是保证治疗质量的可靠保障,” 中华核医学会全国委员会前任主委、中国医科大学附属第一医院核医学科主任李亚明教授表示,“我国甲状腺癌发病率仍呈上升趋势,每年甲状腺切除术后放射性核素碘–131治疗近10万人次。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。”



關于SNA-001

SNA-001是一种重组人促甲状腺素类药物,可安全并快速提升人体血清促甲状腺素水平,极大减轻患者治疗过程中的痛苦,在分化型甲状腺癌碘治疗前准备与随访复查检测中均有着重要的临床应用价值。中美相关临床指南均强力推荐使用 rhTSH药物做为分化甲状腺癌治疗过程中停用甲状腺素的取代疗法。


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有望成爲中國大陸首個rhTSH藥物,上市後將産生巨大的社會效益及經濟效益。



關于智核生物

智核生物于2015年由苏州太阳城娱乐徐霆博士发起成立,位于苏州工业园区,是一家专注核医学诊疗药物研发与应用的创新型医药公司,拥有全球领先的纳米抗体-核素药物研發平台技术。公司自成立以来已获得两轮共数千万元人民币投资,投资方包括薄荷天使基金、沃生投资、翼朴资本和隆门资本。




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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