智核生物获NMPA首个重组人促甲状腺素(rhTSH)临床试验批件_业界静态_消息中央_姑苏康宁杰瑞生物科技无穷公司

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      智核生物获NMPA首个重组人促甲状腺素(rhTSH)临床试验批件

      光阴:2019-07-24 文章来源: 智核生物 打印 字号:大中小



      中国姑苏产业园区,2018年10月22日——姑苏智核生物医药科技无穷公司(简称“智核生物”)是一家专一于核医学诊疗生物药开拓与应用的立异型生物医药公司。公司于今日宣布,其在研产品重组人促甲状腺素SNA-001取得了中国国度药品监督解决局(NMPA)发表的药物临床试验批件。


      rhTSH药物在临床核医学科用于分化型甲状腺癌碘治疗前准备与随访复查检测,在国内尚无同种类上市或同类临床批件,临床上无药可用。智核生物SNA-001有望成为中国大陆首个rhTSH药物。


      “全体员工非常振奋的获悉SNA-001获得临床试验批件,” 智核生物首席履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,同时该批件对咱咱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,咱咱们的全球化团队很高兴能将这一重要药物带给中国宽大的甲状腺肿瘤患者。”


      rhTSH是国内上甲状腺癌治疗前准备的重要药品,是包管治疗品德的靠得住包管,” 中华核医学会世界委员会前任主委、中国医科大学附属第一病院核医学科主任李亚明传授表示,“我国甲状腺癌发病率仍呈上升趋向,每一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早日进入临床医疗,减轻和防止病人治疗过程中甲减的痛苦和危险,提高治疗的品德和疗效。等待SNA-001项目工作顺遂睁开和推动,早日填补国内空白。”



      对付SNA-001

      SNA-001是一种重组人促甲状腺素类药物,可平安并疾速晋升人体血清促甲状腺素程度,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。中美相干临床指南均强力推荐应用 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。


      中国每一年新发甲状腺癌约10万人,且比年来敏捷增长,但大陆地区至今无任何一个rhTSH类药物上市,市场完全空白,医生与病人无药可用。智核生物SNA-001有望成为中国大陆首个rhTSH药物,上市后将发生弘大的社会效益及经济效益。



      对付智核生物

      智核生物于2015年由姑苏康宁杰瑞徐霆博士提议树立,位于姑苏产业园区,是一家专一核医学诊疗药物研发与应用的立异型医药公司,拥有全球抢先的纳米抗体-核素药物老虎机app国际版官网技能。公司自树立以来已获得两轮共数千万元国民币投资,投资方包含薄荷天使基金、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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