A Randomized, Open-label, Multi-center, Controlled Phase Ⅲ Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone（rhTSH） for Adjuvant Radioiodine Ablation Therapy in Postoperative Patients With Differentiated Thyroid Cancer

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.

开始日期2021-10-06

申办/合作机构

苏州泽璟生物制药股份有限公司

CTR20211448 / Recruiting临床3期

重组人促甲状腺激素（rhTSH）用于分化型甲状腺癌患者术后放射性碘清甲治疗的有效性和安全性的随机、开放、多中心、平行对照的Ⅲ期临床研究

主要目的：评价rhTSH用于分化型甲状腺癌切除术后放射性碘（RAI）清甲治疗的疗效非劣效于常规撤除甲状腺激素治疗（THW）。次要目的：（1）评价清甲治疗效果（血清Tg、 TgAb、TSH 升降水平，生活质量评分变化）；（2）观察rhTSH用于分化型甲状腺癌切除术后患者RAI清甲治疗的安全性；（3）观察rhTSH用于分化型甲状腺癌切除术后患者RAI清甲治疗的免疫原性。

开始日期2021-09-23

申办/合作机构

苏州泽璟生物制药股份有限公司

NCT04971473 / Completed临床3期

An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

开始日期2021-09-10

申办/合作机构

苏州泽璟生物制药股份有限公司

100 项与重组人促甲状腺激素 (苏州泽璟生物制药) 相关的临床结果

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100 项与重组人促甲状腺激素 (苏州泽璟生物制药) 相关的转化医学

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100 项与重组人促甲状腺激素 (苏州泽璟生物制药) 相关的专利（医药）

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项与重组人促甲状腺激素 (苏州泽璟生物制药) 相关的文献（医药）

2023-02-01·The Kaohsiung Journal of Medical Sciences

Recombinant human thyrotropin versus thyroid hormone withdrawal preparation for radioiodine ablation in differentiated thyroid cancer: Experience in a South Taiwanese medical center

Article

作者: Chen, Yung‐Nien ; Wu, Shu‐Ting ; Chan, Yi‐Chia ; Lim, Lay San ; Tsai, Jia‐Ruei ; Yang, Yi‐Ting ; Chiew, Yvonne Ee Wern ; Chi, Shun‐Yu ; Chen, Wen‐Chieh ; Chou, Chen‐Kai

AbstractThis retrospective study was designed to compare the treatment response of patients with differentiated thyroid cancer (DTC) prepared for radioiodine ablation (RIA) with thyroid hormone withdrawal (THW) or recombinant human thyrotropin (rhTSH) stimulation. Patients with DTC were followed‐up retrospectively between 2013 and 2018 in Kaohsiung Chang Gung Memorial Hospital, Taiwan. We compared the excellent response ratios between THW (49.9%) and rhTSH (50.1%) stimulation. Patients were then divided into subgroups, on the basis of age, sex, extrathyroidal extension, lymph node metastasis, and tumor‐node‐metastasis stage, for analysis. In all, 647 patients were followed‐up after RIA. The ratios of THW or rhTSH use in the different subgroups were not statistically significant. In all the patients, the excellent response rate with THW and rhTSH was 80% and 76.5%, respectively, which was not statistically significant. The subgroup analysis, including age, sex, extrathyroidal extension, lymph node metastasis, and tumor‐node‐metastasis stage (low and high risk), showed similar results. Furthermore, the logistic regression analysis revealed no statistically significant differences among the subgroups. The multivariate analysis showed extrathyroidal extension, lymph node metastasis, and high I131 dose were the prognostic factors affecting the excellent response rate. In conclusion, the THW and rhTSH preparations for RIA were similar in terms of the excellent response rates and subgroup clinical outcomes.

2022-03-10·New England Journal of Medicine1区 · 医学

Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer

1区 · 医学

Article

作者: Velayoudom, Fritz-Line ; Vera, Pierre ; Bournaud, Claire ; Leboulleux, Sophie ; Kelly, Antony ; Lamartina, Livia ; Borget, Isabelle ; Al Ghuzlan, Abir ; Lacroix, Ludovic ; Benisvy, Danielle ; Roudaut, Nathalie ; Do Cao, Christine ; Bastie, Delphine ; Barge, Marie-Luce ; Drutel, Anne ; Le Moullec, Nathalie ; Leenhardt, Laurence ; Rusu, Daniela ; Nascimento, Camila ; Dygai, Inna ; Giraudet, Anne-Laure ; Drui, Delphine ; Zerdoud, Slimane ; Catargi, Bogdan ; Eberle, Marie-Claude ; Chougnet, Cecile N. ; Roux, Julie ; Schlumberger, Martin-Jean ; Bardet, Stéphane ; Schneegans, Olivier ; Klein, Marc ; Morel, Olivier ; Schvartz, Claire ; Godbert, Yann

BACKGROUNDIn patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits.METHODSIn this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization.RESULTSAmong 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of -0.3 percentage points (two-sided 90% CI, -2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported.CONCLUSIONSIn patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years. (Funded by the French National Cancer Institute; ESTIMABL2 ClinicalTrials.gov number, NCT01837745.).

2021-12-28·The Cochrane database of systematic reviews

Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre.

Review

作者: Ma, Chao ; Xie, Jiawei ; Wang, Hui ; Chen, Suyun ; Huo, Yanlei

BACKGROUNDMultinodular goitre is common in women. Treatments for non-toxic multinodular goitre include surgery, levothyroxine suppressive therapy, and radioiodine. Radioiodine therapy is the only non-surgical alternative for non-toxic multinodular goitre. However, a high amount of radioiodine is needed to enable the thyroid nodules to adequately take up the radioiodine, because the multinodular goitre takes up a low amount of iodine. Recombinant human thyrotropin (rhTSH) has been used to increase radioiodine uptake and reduce thyroid volume of the multinodular goitre. Whether the improved reduction of the goitre resulting from rhTSH-stimulated radioiodine therapy is beneficial to the person remains controversial.OBJECTIVESTo assess the effects of recombinant human thyrotropin-aided radioiodine treatment for non-toxic multinodular goitre.SEARCH METHODSWe searched the CENTRAL, MEDLINE, Scopus as well as ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 18 December 2020.SELECTION CRITERIAWe included randomised controlled clinical trials (RCTs) comparing the effects of rhTSH-aided radioiodine treatment compared with radioiodine alone for non-toxic multinodular goitre, with at least 12 months of follow-up.DATA COLLECTION AND ANALYSISTwo review authors independently screened titles and abstracts for relevance. Screening for inclusion, data extraction, and risk of bias assessment were carried out by one review author and checked by a second. Our main outcomes were health-related quality of life (QoL), hypothyroidism, adverse events, thyroid volume, all-cause mortality, and costs. We used a random-effects model to perform meta-analyses, and calculated risk ratios (RRs) for dichotomous outcomes, and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We evaluated the certainty of the evidence using the GRADE approach.MAIN RESULTSWe included six RCTs. A total of 197 participants were allocated to rhTSh-aided radioiodine therapy, and 124 participants were allocated to radioiodine. A single dose of radioiodine was administered 24 hours after the intramuscular injection of a single dose of rhTSH. The duration of follow-up ranged between 12 and 36 months. Low-certainty evidence from one study, with 85 participants, showed uncertain effects for QoL for either intervention. RhTSH-aided radioiodine increased hypothyroidism compared with radioiodine alone (64/197 participants (32.5%) in the rhTSH-aided radioiodine group versus 15/124 participants (12.1%) in the radioiodine alone group; RR 2.53, 95% CI 1.52 to 4.20; 6 studies, 321 participants; moderate-certainty evidence in favour of radioiodine alone). A total of 118/197 participants (59.9%) in the rhTSH-aided radioiodine group compared with 60/124 participants (48.4%) in the radioiodine alone group experienced adverse events (random-effects RR 1.24, 95% CI 0.94 to 1.63; 6 studies, 321 participants; fixed-effect RR 1.23, 95% CI 1.02 to 1.49 in favour of radioiodine only; low-certainty evidence). RhTSH-aided radioiodine reduced thyroid volume with a MD of 11.9% (95% CI 4.4 to 19.4; 6 studies, 268 participants; moderate-certainty evidence). One study with 28 participants reported one death in the radioiodine alone group (very-low certainty evidence). No study reported on costs.AUTHORS' CONCLUSIONSRhTSH-aided radioiodine treatment for non-toxic multinodular goitre, compared to radioiodine alone, probably increased the risk of hypothyroidism but probably led to a greater reduction in thyroid volume. Data on QoL and costs were sparse or missing.

项与重组人促甲状腺激素 (苏州泽璟生物制药) 相关的新闻（医药）

2024-09-24

·BioBAY

向上生长、向下扎根！生物医药高地昂扬向前

日前，2024未来产业创新发展交流大会现场，苏州工业园区细胞和基因技术产业领域成功入选首批“未来产业先行集聚发展试点”清单。园区，正积极拥抱新一轮科技革命和产业变革，再次抢抓生物医药领域新机遇，竞逐未来产业新赛道。生物医药是国家重点支持的战略性新兴产业，未来产业的重要领域之一，园区从2006年播下这颗“种子”后，经过十多年培育发展，生物医药类顶尖人才数占全国同类人才的比重达25%以上，集聚生物医药及大健康企业超2000家，2023年产值超1500亿元，产业竞争力位居全国第一方阵。一批批创新企业在这里诞生、成长、走向世界一项项创新成果在这里孕育、转化、开花结果园区处处跃动着竞逐新质生产力的蓬勃朝气选择沃土，落地生根 CRO企业在制药产业链中扮演不可或缺的角色，是制药企业缩短药物研发周期、实现药品快速上市的重要手段。 2023年落户园区的苏州益铂生物科技发展有限公司，就是这样一家专注于药物早期筛选、非临床药理药效、DMPK与安全性评价的CRO公司，成立当年就成为国家生物药技术创新中心试验动物平台。作为CRO领域的后起之秀，成立一年多来，益铂生物获得了学术界及产业界的广泛认可。今年8月，益铂生物于园区正式开业。这只是园区上半年企业开工启航的一个掠影。复百澳生物、浩欧博、微谱生物、帕母医疗、苏州赛赋等一众优质生物医药企业开工开业多点开花，不断拓展着园区生物医药及大健康产业的广度和深度。融入产业“顶级朋友圈”，协同研发、生产、拓展业务渠道，一家又一家企业在这里落地生根、创造未来，创新的“种子”在这里激活高质量发展新动能。自主创新，多点开花近日，园区科技领军人才企业——苏州盛迪亚生物医药有限公司自主研发的1类创新药夫那奇珠单抗注射液（安达静®）获国家药品监督管理局批准上市，用于治疗适合接受系统治疗或光疗的中重度斑块状银屑病成人患者。这是中国首个获批的本土自主研发重组抗IL-17A人源化单克隆抗体，也是今年苏州市获批的第2款1类创新药，将打破同类进口药物的长期垄断局面，为银屑病患者提供新的治疗选择。今年以来作为园区重点培育的战略性新兴产业生物医药及大健康产业创新之潮涌动一众创新企业纷纷亮出王牌产品和最新研发成果迸发出园区发展新质生产力的动能和基因 ►清谱科技团队和清华大学使用清谱科技研发的小型质谱仪平台首次实现了质谱直接分析手性分子； ►智核生物人促甲状腺素注射液（智舒嘉®）获批上市，为国内首个上市的重组人促甲状腺激素（rhTSH）； ►兴盟生物自主研发的1类创新药——泽美洛韦玛佐瑞韦单抗注射液（克瑞毕®）获批上市，这是国内首款获批上市的抗狂犬病毒复方抗体制剂，也是苏州市今年首款获批上市的1类创新药，已于7月全国发售； ►精微医疗国产首款两步式自动注射笔ComforJet®两步式自动注射笔上市； …… 截至目前，园区已上市新药33款，其中1类创新药17款；33个医疗器械产品进入国家医疗器械创新产品审批“绿色通道”，其中18款获批上市销售，园区已形成了优质项目纷至沓来、创新成果不断涌现的发展态势，生物医药及大健康产业发展不断提速。加速“出海”，面向全球生物医药产业高质量发展离不开创新，而生物医药“出海”也是药企创新能力不断提升的体现，是走向全球市场的关键所在。今年1月，姑苏领军重大创新团队企业、园区科技领军人才企业——苏州宜联生物医药有限公司宣布与罗氏达成全球合作和许可协议，双方将合作开发靶向间质表皮转化因子（c-MET）的下一代抗体偶联（ADC）药物候选产品YL211，用于治疗实体瘤。这是2024年第一单中国创新药“出海”，根据协议条款，交易金额超过10亿美元。近年来我国药企新药研发力度不断增强生物医药企业“出海”不断提速其中，园区生物医药企业表现亮眼积极拥抱国际市场 // 2023年园区生物医药海外授权合作事件数累计19件，占全国24%，排名全国第二，其中全国合作交易总金额超10亿美元事件中，园区企业数占比约40%，除了宜联生物外，百图生科、和铂医药等都获得超过10亿美元的总交易额。在资本市场方面，园区生物医药企业同样屡受外资青睐。2024年以来，阿斯利康以12亿美元收购亘喜生物，丹麦企业Genmab以18亿美元收购普方生物。从“聚合”到“聚变”，园区发展生物医药及大健康产业步履不停，正在被全世界“看到”，在未来的发展还有更多的想象和空间。 ▌文章来源：SIP科技创新责编：何文正审核：任旭推荐阅读第八届全国核酸疫苗大会开幕式于园区举行中国新闻周刊关注！BioBAY：保持定力和韧劲往前冲 BioBAY-HK Trip

上市批准一致性评价医药出海

2024-09-13

·同写意

创新的脚步从未停歇，医药的硕果正挂枝头

蛋白降解靶向嵌合体引进/卖出临床申请

2024-09-13

·BioBAY

2024江苏产学研合作对接大会开幕！国家生物药技术创新中心携创新成果亮相

9月11-12日，以“科技赋能新质生产力，创新引领高质量发展”为主题的2024江苏产学研合作对接大会在南京举办。国家生物药技术创新中心（以下简称“国创中心”）携多个产业化基地项目创新成果亮相本届大会。本届大会由江苏省科技厅主办、江苏省生产力促进中心承办，以“主题大会+展览对接+专题活动+专家江苏行”为总体框架，围绕江苏省重点培育发展的战略性新兴产业和未来产业，发布一批科技成果和创新需求，广泛组织科技界、产业界、金融界人士对接洽谈。省委书记信长星出席并启动开幕。省长许昆林，科技部党组成员、科技日报社社长张碧涌，中国科学院院士、中国科学院副院长常进致辞。大会开幕前，信长星、许昆林参观了重点科技成果展示，会见了部分与会嘉宾。信长星代表省委、省政府感谢科技部、中国科学院和各高校院所长期以来给予江苏发展的大力支持，感谢各位院士专家多年来为江苏发展作出的贡献。他说，党的二十届三中全会对构建支持全面创新体制机制作出部署，推动科技创新和产业创新融合发展、加强企业主导的产学研深度融合是其中的重要举措。当前，江苏正在加快打造发展新质生产力的重要阵地，尤其需要增加高质量科技供给，引导企业与高校院所密切合作，共同凝练科技问题，联合开展科研攻关，以科技创新引领产业创新，塑造发展新动能新优势。举办产学研合作对接大会，就是要做好“融合”的大文章，实现双向赋能。希望大家继续给予指导支持，推动更多科技成果在江苏落地转化。江苏将落细落实各项改革举措，为深化产学研合作营造更好环境、提供更优服务。与会嘉宾表示，江苏在产业基础、科教资源、市场规模等方面具有突出优势，将面向国家战略需求、结合江苏发展实际，持续拓展交流合作，为江苏在高质量发展上继续走在前列贡献智慧和力量。展览现场，设置国家技术创新中心科技成果区域。国创中心现场展示托莱西单抗注射液（信必乐®）、泽美洛韦玛佐瑞韦单抗注射液（克瑞毕®）、重组人促甲状腺激素（智舒嘉®）等多个产业化基地项目创新成果。信达生物托莱西单抗注射液（信必乐®）托莱西单抗注射液（信必乐®）是国创中心产业化基地项目信达生物自主研发的PCSK9抑制剂，是国家重大新药创制专项支持品种，于2023年获批上市，用于治疗原发性高胆固醇血症（包括杂合子型家族性和非家族性高胆固醇血症）和混合型血脂异常。这是信达生物布局心血管疾病领域的首款产品，也是国内首款获批的自主研发的重组全人源抗PCSK9单克隆抗体，能显著降低LDL-C水平，为我国血脂临床管理带来了全新治疗选择。兴盟生物泽美洛韦玛佐瑞韦单抗注射液（克瑞毕®）泽美洛韦玛佐瑞韦单抗注射液（克瑞毕®）是国创中心产业化基地项目兴盟生物自主研发和生产的重组抗狂犬病毒人源化鸡尾酒抗体，于2024年6月12日取得国家药品监督管理局颁发的药品注册批件，正式获批用于成人狂犬病病毒暴露者的被动免疫治疗。该产品为国内首个符合世界卫生组织推荐的抗狂犬病鸡尾酒抗体，这一成果标志着我国在狂犬病被动免疫领域取得了重大突破，为狂犬病防治提供了重要选择。智核生物重组人促甲状腺激素（智舒嘉®）重组人促甲状腺激素（智舒嘉®）是国创中心产业化基地项目智核生物持有的一种通过重组DNA技术产生的异二聚体糖蛋白，现已获批上市。该产品为创新预充水针剂型，可在首次注射48小时内100%快速提升患者体内促甲状腺激素水平，促进碘摄取和有机化，便于分化型甲状腺癌患者快速接受碘治疗。智舒嘉®已成为我国首款获批的重组人促甲状腺激素产品，填补了我国多年来甲状腺癌治疗的空缺。在主题大会上，许昆林、张碧涌、常进分别致辞。许昆林表示，我们将聚焦关键核心技术攻关，以颠覆性技术突破引领新质生产力发展；加强科技成果转化应用，以科技创新引领现代化产业体系建设；营造一流创新生态，以开放合作塑造创新发展新优势，着力打造具有全球影响力的产业科技创新中心，成为发展新质生产力的重要阵地。希望以此次大会为契机，更大力度促进企业与高校、科研机构密切合作，实现产学研融通创新。张碧涌表示，科技部将一如既往支持江苏在加强科技创新和产业创新融合发展、因地制宜发展新质生产力等方面深化探索实践，助力江苏在国家科技创新格局中勇担“第一方阵”使命。常进表示，中国科学院将落实好新一轮院省战略合作协议，通过部署重大创新项目、加快关键核心技术突破、促进科技成果转化应用等，为江苏高质量发展注入强劲动能。中国科学院院士、清华大学教授姚期智，中国科学院院士、东南大学校长黄如作主旨发言，省科技厅负责人介绍了上届大会以来全省产学研合作情况。江苏数字科技平台上线运行。 50多位两院院士、70多名高校院所负责同志，境内外知名高校和科技服务机构、全省科技型企业代表参加活动。大会现场发布了省内外158家高校院所的2000多项最新成果、1900多家企业的2300多项技术需求，24个产学研重大合作项目集中签约，还将举行成果对接、专家江苏行等活动。省领导韩立明、刘建洋、储永宏、马欣、赵岩出席开幕活动。 ▌文章来源：国家生物药技术创新中心责编：何文正审核：任旭推荐阅读 BioBAY：创新的脚步从未停歇，医药的硕果正挂枝头小小“关心助企”工作站，服务“一号产业”大作为双平台升级，自贸区生物医药企业又享红利

AHA会议

100 项与重组人促甲状腺激素 (苏州泽璟生物制药) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
分化型甲状腺癌	申请上市	中国	苏州泽璟生物制药股份有限公司	2024-06-18
内脏异位综合征	临床2期	中国	苏州泽璟生物制药股份有限公司	2020-11-12