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 ; Borget, Isabelle ; Lamartina, Livia ; Al Ghuzlan, Abir ; Lacroix, Ludovic ; Benisvy, Danielle ; Roudaut, Nathalie ; Bastie, Delphine ; Do Cao, Christine ; Barge, Marie-Luce ; Le Moullec, Nathalie ; Drutel, Anne ; Leenhardt, Laurence ; Rusu, Daniela ; Nascimento, Camila ; Dygai, Inna ; Giraudet, Anne-Laure ; Drui, Delphine ; Zerdoud, Slimane ; Catargi, Bogdan ; Eberle, Marie-Claude ; Chougnet, Cecile N. ; Schlumberger, Martin-Jean ; Roux, Julie ; 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

2024-09-24

·药渡Daily

这些国产创新药，即将获批上市

虽然行业仍处于寒冬时期，但创新药企却取得了不错的“成绩单”，中国药企在创新的靶点和机制研究上不断取得新的进展，拓展产品管线，近期，将有哪些创新药获批上市？本文对主要创新药企的产品管线及研发进展进行梳理，从中选择出有望在近阶段获批上市的创新药，与读者分享。图1.部分创新药企2024年H1营收情况（单位：亿元）资料来源：企业中报，作者整理信达生物玛仕度肽减重、降糖适应症均已递交NDA 2024年H1产品收入实现38.1亿元，同比增长55%，信迪利单抗等主要产品销售表现持续强劲，对收入贡献日益增加。信达生物的管线储备丰富，截至目前共递交5项新药NDA，包括IBI310（CTLA-4）用于结肠癌辅助治疗（联合信迪利单抗）；替妥尤单抗（IGF-1R）治疗甲状腺眼病；玛仕度肽（GLP-1R/GCGR）治疗2型糖尿病、长期体重控制；匹康奇拜单抗（IL-23p19）治疗银屑病。玛仕度肽是信达生物心血管及代谢疾病领域的基石产品，是目前研发进展最快的GLP-1R/CGCR双靶点激动剂。 2024年2月，玛仕度肽减重适应症NDA获受理，NMPA审评正在进行。玛仕度肽能够显著降低体重，减重效果媲美司美格鲁肽和替尔泊肽，并带来肝脏获益。GLORY-1临床III期研究结果显示，第48周，玛仕度肽6mg和9mg治疗组体重较安慰剂组分别下降14.4%和18.6%，玛仕度肽6mg治疗组肝脏脂肪含量减少80.2%。图2.GLORY-1临床结果-减重效果资料来源：2024 ADA 图3.GLORY-1临床结果-肝脏获益资料来源：ADA 2024 2024年8月，玛仕度肽第二项糖尿病适应症NDA获受理，针对饮食及运动控制不佳的未经治疗T2D人群、口服降糖药失效T2D人群，均能实现降糖减重的疗效。玛仕度肽减重及降糖适应症预计2025年获批。此外，信达生物正在拓宽玛仕度肽高潜适应症，包括代谢相关脂肪性肝炎（MASH）、阻塞性睡眠呼吸暂停和射血分数保留型心衰。其中，MASH已获批IND。君实生物昂戈瑞西单抗4项NDA获得受理 2024年H1实现营业收入7.9亿元，同比增长17%，主要系创新药销售收入显著增长，其中，特瑞普利单抗国内销售收入6.7亿元，同比增长约50%。截至目前，特瑞普利单抗共有10项适应症已获得NMPA批准上市，6项纳入医保，是战略布局最广的国产PD-1单抗之一。图4.特瑞普利单抗获批适应症资料来源：君实生物2024年中期报告除了肿瘤领域，君实生物在新冠病毒、心血管、自身免疫和神经系统疾病领域均有布局。其中，昂戈瑞西单抗（抗PCSK9单抗）已有4项适应症上市申请已获受理： 2023年4月，NMPA受理了昂戈瑞西单抗2项适应症的上市申请，用于治疗：原发性高胆固醇血症和混合型血脂异常（联合他汀）；纯合子型家族性高胆固醇血症。 2024年4月，新增两项适应症上市申请获NMPA受理，用于治疗：杂合子型家族性高胆固醇血症、他汀类药物不耐受或禁忌使用的原发性高胆固醇血症和混合型血脂异常。相关研究结果显示，昂戈瑞西单抗150mg（Q2W）、300mg（Q4W）治疗组可显著降低LDL-C水平达60%以上，并且在52周治疗期间始终维持稳定的降幅。图5.昂戈瑞西单抗治疗效果资料来源：君实生物2024年中期报告再鼎医药未来一年预计递交4项NDA 2024年H1实现产品收入1.9亿美元，同比增长42%。未来一年，再鼎医药计划将在中国提交4项NDA，包括：肿瘤电场治疗用于二线以上非小细胞肺癌；TIVDAK用于治疗二线及以上宫颈癌；KarXT用于治疗精神分裂症；瑞普替尼用于治疗NTRK+实体瘤。肿瘤电场治疗是一种便携式无创治疗方式，通过在肿瘤内部形成低强度的交流电场，阻止肿瘤细胞正常有丝分裂，从而延缓和逆转肿瘤生长。针对二线及以上非小细胞肺癌的LUNAR三期临床研究结果显示，相较于标准疗法，肿瘤电场治疗 (TTFields) 联合标准治疗的中位总生存期有显著统计学意义和临床意义的3个月改善（13.2个月VS.9.9个月）。针对一线非小细胞肺癌脑转移的METIS三期临床研究结果显示，与单独接受支持疗法组相比, TTFields联合支持疗法的中位至颅内进展时间有统计学上的显著改善（21.9个月VS.11.3个月）。 TIVDAK是目前首款且唯一获FDA批准的治疗复发性或转移性宫颈癌的ADC药物，预计将在2024年-2025年H1在中国递交上市申请。 KarXT是一款口服M1/M4型毒蕈碱乙酰胆碱受体激动剂，不直接阻断多巴胺受体，通过靶向毒蕈碱乙酰胆碱受体M1和M4，调节乙酰胆碱进而调节多巴胺水平，针对精神分裂症的三项注册性研究中, 均显示出显著的阳性和阴性症状的改善。图6.KarXT针对精神分裂症的三项注册性研究中均显示出良好疗效资料来源：再鼎医药今年5月，再鼎医药瑞普替尼获NMPA批准，用于治疗ROS1阳性的局部晚期或转移性非小细胞肺癌成人患者。未来，瑞普替尼不仅限于非小细胞肺癌的治疗，早在2021年，FDA曾授予瑞普替尼用于治疗携带NTRK基因融合的晚期实体瘤患者的突破性疗法认定。三生国健自免管线推进迅速 2024年H1实现营收6亿元，同比增长25%，核心产品益赛普实现营收3.3亿元，同比增长9.4%，收入稳健增长。三生国健自身免疫管线进展迅速，目前，共有5项III期临床项目，分别为： 608（IL-17），用于治疗中重度斑块状银屑病；III期结果积极，达到临床主要终点，预计将于今年四季度申报NDA。 610（IL-5），用于治疗成人嗜酸性粒细胞哮喘，2024年6月完成首例入组； 611（IL-4R），用于治疗成人中重度特应性皮炎，2024年1月完成首例入组； 611（IL-4R），用于治疗慢性鼻窦炎伴鼻息肉，II期达到临床终点，并已启动III期； 613（IL-1β），用于治疗痛风性关节炎（急性期），2024年1月完成首例入组，目前正在入组中。康诺亚司普奇拜单抗2项NDA获受理 2024年H1实现收入5468万元，主要为CMG901第一笔研发里程碑收入。核心管线司普奇拜单抗已于2024年上半年提交2项NDA申请，分别为：司普奇拜单抗用于治疗慢性鼻窦炎伴鼻息肉病，于2024年6月获得受理；司普奇拜单抗治疗季节性过敏性鼻炎，于2024年4月获得受理。此外，司普奇拜单抗用于治疗成人中重度特应性皮炎的NDA于2023年12月受理，已经于近日成功获批。2024 EAACI会议上，康诺亚披露了司普奇拜单抗治疗成人中重度特应性皮炎的长期疗效数据：第52周时，司普奇拜单抗组的EASI-75达标率为92.5%，EASI-90达标率为77.1%。百奥泰乌司奴单抗已于中美欧三地递交NDA 2024年H1实现营收4亿元，同比增长28%。乌司奴单抗注射液是一款靶向白细胞介素IL-12和IL-23共有的P40亚基的全人源单克隆抗体。IL-12和IL-23细胞因子能够参与炎症和免疫应答过程，可以与p40亚基以高亲和力特异性地结合，阻断其与细胞表面受体结合，从而破坏IL-12和IL-23介导的信号传导和细胞因子的效应。目前，乌司奴单抗已向中国、美国和欧洲递交上市申请并获得受理。诺诚健华首个实体瘤产品进入pre-NDA阶段 2024年H1实现营收4.2亿元，同比增长31%，主要系奥布替尼销售收入持续增长，2024年H1奥布替尼实现营收4.17亿元，同比增长30%。诺诚健华血液肿瘤领域全方位覆盖，目前，共布局6款产品，覆盖骨髓瘤、非霍奇金淋巴瘤和白血病等多个适应症领域。其中，坦昔妥单抗（CD19）联合来那度胺治疗r/rDLBCL的上市申请已获得受理并纳入优先审评；奥布替尼新适应症1L CLL/SLL申请已获受理。诺诚健华实体瘤领域首款产品ICP-723进入pre-NDA阶段，有望于2025年Q1递交NDA。针对NTRK基因融合阳性患者的注册性II期临床试验已完成，客观缓解率达到80-90%，有效反应持续时间较长，最长可超过36个月。泽璟制药 2款新药处于上市审评中 2024年H1实现营收2.4亿元，同比增长9%，主要系多纳非尼片销量增加所致。 2022年10月，泽璟制药递交的吉卡昔替尼片治疗中、高危骨髓纤维化适应症的NDA申请已获NMPA受理，是第一个提交治疗骨髓纤维化适应症NDA的国产JAK抑制剂类创新药物，目前在上市前技术审评阶段。另一款药物注射用重组人促甲状腺激素（rhTSH）也已经提交新药上市申请并已获受理，用于在分化型甲状腺癌患者的随访中用作放射性碘全身成像检查和血清甲状腺球蛋白监测诊断药物。中国医药创新已走过初期的“野蛮生长”阶段，正迎来“大浪淘沙”的发展阶段，真正具有临床价值的创新药才会最终被留下。这些即将实现商业化的创新药将在未来展现出强劲的增长潜力，在市场中大放异彩。参考资料各大企业中报路演材料，投资者报告

临床申请临床3期申请上市

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

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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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