隆培促生长素(Lonapegsomatropin-tcgd) - 药物靶点：GR_在研适应症：生长激素缺乏症，激素缺乏症，软骨发育不全_专利_临床

概要

基本信息

药物类型

激素

别名

Lonapegsomatropin、TransCon、TransCon growth hormone

+ [9]

靶点

GR

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

神经系统疾病内分泌与代谢疾病其他疾病+ [4]

在研适应症

生长激素缺乏症激素缺乏症软骨发育不全+ [1]

非在研适应症

垂体性侏儒症

原研机构

Ascendis Pharma A/S

在研机构

Ascendis Pharma Endocrinology Division A/S

Ascendis Pharma A/S

Vetter Pharma-Fertigung GmbH & Co. KG

+ [2]

非在研机构

VISEN Pharmaceuticals

最高研发阶段批准上市

首次获批日期

美国 (2021-08-25),

生长激素缺乏症

最高研发阶段(中国)申请上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)

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序列信息

Sequence Code 26401985

来源: *****

关联

16

项与隆培促生长素相关的临床试验

NCT06433557 / Recruiting临床2期

A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia

This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.

开始日期2024-07-26

申办/合作机构

Ascendis Pharma Growth Disorders A/S

CTIS2023-508341-40-00 / Recruiting

COACH: A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children with Achondroplasia - ASND0042

开始日期2024-07-26

申办/合作机构

Ascendis Pharma Growth Disorders A/S

NCT05775523 / RecruitingN/A

A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

开始日期2023-03-20

申办/合作机构

Ascendis Pharma Endocrinology Division A/S

100 项与隆培促生长素相关的临床结果

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100 项与隆培促生长素相关的转化医学

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100 项与隆培促生长素相关的专利（医药）

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37

项与隆培促生长素相关的文献（医药）

2023-01-01·Hormone research in paediatrics

Weekly Growth Hormone (Lonapegsomatropin) Causes Severe Transient Hyperglycemia in a Child with Obesity

作者: Estrada, Doris Elizabeth ; Majidi, Shideh ; Dauber, Andrew ; Alkhatib, Einas H

Introduction: A 12-year-and-9-month-old non-Hispanic black male with a history of growth hormone deficiency, pituitary hypoplasia, prediabetes, obesity, hypertension, and hyperlipidemia was initiated on weekly growth hormone (lonapegsomatropin-tcgd) and then transiently developed symptomatic hyperglycemia to 500 mg/dL. We aimed to describe this medication’s effect. Case Presentation: He was born full term and appropriate for gestational age. He was referred to endocrinology at 3.5 years of age for short stature with a height SDS of −2.48. IGF-1 51.1 ng/mL and IGFBP-3 1.2 ng/mL were low. GH stimulation test noted baseline and peak GH of 0.1 ng/mL. MRI brain showed hypoplastic adenohypophysis, aplastic pituitary stalk, and ectopic neurohypophysis. There had been difficulty with adherence to daily GH over the following 9 years. BMI trajectory rose above 180% of the 95th percentile. By age 12, A1c was 6.6%. Metformin was started and increased to 1,000 mg twice daily. Subsequent A1c was 6.0%. Due to poor compliance with daily GH, at 12 years and 9 months, he was initiated on 22 mg (0.25 mg/kg/week) of weekly lonapegsomatropin-tcgd to improve compliance. The day after his first injection, he developed non-bloody, non-bilious emesis. He denied headaches and endorsed polyuria. Due to concern for increased intracranial pressure, he was sent to the emergency department; however, ophthalmologic exam was negative. Initial serum glucose was 500 mg/dL, then 336 mg/dL after 1-L normal saline. Hemoglobin A1c was 5.7%, urine glucose 3+ mg/dL, and urine ketones 2+ mg/dL. Venous pH of 7.379 and bicarbonate of 20.6 mmol/L ruled out diabetic ketoacidosis. Metformin was held during the hospitalization. Hyperglycemia rapidly improved with transient insulin administration. He received one dose of glargine 20 units. He was initiated on lispro carb ratio of 1:8 and correction factor 1:15 for target glucose 150 mg/dL. By day four, glucoses were below 100 mg/dL; lispro was discontinued, and he was discharged home. Weekly GH was discontinued with plans to resume daily GH therapy in several months. Conclusion: Lonapegsomatropin-tcgd offers the convenience of weekly rather than daily GH treatment; however, this patient developed a rapid increase in insulin resistance and hyperglycemia requiring insulin. The discrepancy between the glucose of 500 mg/dL and A1c of 5.7%, along with the rapid resolution of hyperglycemia, is further consistent with a medication side effect. Close glucose monitoring of patients initiated on weekly growth hormone is crucial, particularly in those with a history of prediabetes.

2022-06-16·The Journal of clinical endocrinology and metabolism2区 · 医学

Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results

2区 · 医学

Article

作者: Saenger, Paul ; Hofman, Paul L ; Mygind, Per Holse ; Song, Wenjie ; Aghajanova, Elena M ; Maniatis, Aristides K ; Chessler, Steven D ; Malievskiy, Oleg ; Nadgir, Ulhas M ; Mao, Meng ; Beckert, Michael ; Korpal-Szczyrska, Maria ; Chertock, Elena D ; Thornton, Paul S ; Shu, Aimee D ; Smith, Alden R ; Vlachopapadopoulou, Elpis ; Komirenko, Allison S ; Cappa, Marco ; Casella, Samuel J ; Chaychenko, Tetyana

Abstract:

Purpose:

The objectives of the ongoing, Phase 3, open-label extension trial enliGHten are to assess the long-term safety and efficacy of weekly administered long-acting growth hormone lonapegsomatropin in children with growth hormone deficiency.

Methods:

Eligible subjects completing a prior Phase 3 lonapegsomatropin parent trial (heiGHt or fliGHt) were invited to participate. All subjects were treated with lonapegsomatropin. Subjects in the United States switched to the TransCon hGH Auto-Injector when available. Endpoints were long-term safety, annualized height velocity, pharmacodynamics [insulin-like growth factor-1 SD score (SDS) values], and patient- and caregiver-reported assessments of convenience and tolerability.

Results:

Lonapegsomatropin treatment during enliGHten was associated with continued improvements in height SDS through week 104 in treatment-naïve subjects from the heiGHt trial (−2.89 to −1.37 for the lonapegsomatropin group; −3.0 to −1.52 for the daily somatropin group). Height SDS also continued to improve among switch subjects from the fliGHt trial (−1.42 at fliGHt baseline to −0.69 at week 78). After 104 weeks, the average bone age/chronological age ratio for each treatment group was 0.8 (0.1), showing only minimal advancement of bone age relative to chronological age with continued lonapegsomatropin treatment among heiGHt subjects. Fewer local tolerability reactions were reported with the TransCon hGH Auto-Injector compared with syringe/needle.

Conclusions:

Treatment with lonapegsomatropin continued to be safe and well-tolerated, with no new safety signals identified. Children treated with once-weekly lonapegsomatropin showed continued improvement of height SDS through the second year of therapy without excess advancement of bone age.

2022-04-19·The Journal of clinical endocrinology and metabolism2区 · 医学

Response to Letter to the Editor From Malozowski: “Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial”

2区 · 医学

Letter

作者: Karpf, David B ; Giorgadze, Elene ; Christoffersen, Eva Dam ; Maniatis, Aristides K ; Thornton, Paul S ; Breinholt, Vibeke Miller ; Korpal-Szczyrska, Maria ; Song, Wenjie ; Hofman, Paul L ; Beckert, Michael ; Chertok, Elena ; Lin, Zhengning ; Aghajanova, Elena ; Shu, Aimee D

131

项与隆培促生长素相关的新闻（医药）

2024-09-17

·微信

每年长高6厘米！创新疗法关键试验达主要终点

▎药明康德内容团队编辑日前，Ascendis Pharma公布其在研疗法TransCon CNP（navepegritide）在ApproaCH试验的积极顶线数据。分析显示，试验达成主要终点，TransCon CNP相较于安慰剂显著增加软骨发育不全儿童（年龄2-11岁）患者的年化生长速度（AGV）。软骨发育不全主要表现为四肢、脊柱和头骨底部的骨骼生长缓慢。它的发病原因是由于编码成纤维细胞生长因子受体3（FGFR3）的基因出现突变，导致FGFR3蛋白过度活跃。FGFR3是骨骼发育的负向调节分子，可影响软骨细胞的增殖、活化和分化。这次所公布的ApproaCH试验是一项关键双盲安慰剂对照试验，共有84名患有软骨发育不全的儿童（年龄2-11岁）入组，以2：1的比例随机分配接受每周一次TransCon CNP或安慰剂治疗。分析显示，试验达成主要终点。在第52周时，接受TransCon CNP治疗儿童（n=57）的最小二乘（LS）平均AGV为5.89厘米/年，而安慰剂组（n=27）患者的LS平均AGV为4.41厘米/年，两组间的LS平均差异为1.49厘米/年（p<0.0001）。进一步的亚组分析显示，接受TransCon CNP治疗的2至5岁儿童（n=21）在第52周时的LS平均AGV为6.07厘米/年，而安慰剂组（n=10）的LS平均AGV为5.06厘米/年，LS平均差异为1.02厘米/年（p=0.0084）。接受TransCon CNP治疗的5-11岁儿童（n=36）在第52周时的LS平均AGV为5.79厘米/年，而安慰剂组（n=17）的LS平均AGV为4.02厘米/年，LS平均差异为1.78厘米/年（p<0.0001）。 TransCon CNP持续表现出与安慰剂相当的安全性，且总体耐受性良好，治疗中出现的不良事件（TEAE）大多为轻度。图片来源：123RF TransCon CNP是一种在研C型利钠肽（CNP）前体药物，每周给药一次，旨在提供患者活性CNP的持续暴露。C型利钠肽可通过阻断FGFR3的活性，就好像松开抑制儿童生长的“刹车”，直接靶向软骨发育不全的潜在病理生理学，从而促进软骨内骨形成，让患儿的生长速率恢复正常。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Pivotal ApproaCH Trial of TransCon™ CNP (Navepegritide) Achieved Primary Objective, Demonstrated AGV Superior to Placebo. Retrieved September 17, 2024 from https://investors.ascendispharma.com/news-releases/news-release-details/pivotal-approach-trial-transcontm-cnp-navepegritide-achieved 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果CSCO会议

2024-09-16

·PipelineReview

Pivotal ApproaCH Trial of TransCon™ CNP (Navepegritide) Achieved Primary Objective, Demonstrated AGV Superior to Placebo

– TransCon CNP demonstrated AGV superior to placebo with LS mean treatment difference of 1.49 cm/year at Week 52 (p<0.0001) – For children aged 5-11 years TransCon CNP demonstrated a change from baseline AGV superior to placebo with LS mean treatment difference of 1.78 cm/year at Week 52 (p<0.0001) – Other endpoints supportive that TransCon CNP may provide benefits beyond linear growth – TransCon CNP was generally well-tolerated, with low frequency of injection site reactions (0.41 events per patient year), all mild – Ascendis to host investor conference call Monday, September 16, at 8:00 a.m. E.T. COPENHAGEN, Denmark I September 16, 2024 I Ascendis Pharma A/S (Nasdaq: ASND) today announced topline data from the pivotal double-blind placebo-controlled ApproaCH Trial of TransCon CNP (navepegritide), which included 84 children with achondroplasia (ages 2-11 years) randomized 2:1 (TransCon CNP:placebo). TransCon CNP is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly and designed to provide sustained release and continuous exposure of active CNP. In the trial, children treated with once-weekly TransCon CNP demonstrated annualized growth velocity (AGV) superior to placebo. TransCon CNP also demonstrated statistically significant improvements in other growth parameters, including height Z-score and change from baseline AGV. “Results of this pivotal trial demonstrate that once-weekly TransCon CNP can, if approved, address the need for an efficacious, safe, tolerable, and convenient treatment for children with achondroplasia,” said Ravi Savarirayan, M.D., at the Murdoch Children’s Research Center (Australia) and an investigator in the ApproaCH Trial. “I am excited about the possibilities TransCon CNP presents for a potential new treatment option for these children that will allow decreased injection frequency, improved compliance, and reduced caregiver burden.” “TransCon CNP-treated children with achondroplasia exceeded the growth rate of the general population, suggesting that once-weekly TransCon CNP provides catch-up growth with safety and tolerability results comparable to placebo with a low incidence of injection-site reactions,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “With SKYTROFA ® and TransCon CNP, Ascendis is uniquely positioned to become the leader in the treatment of skeletal dysplasias and growth disorders.” Highlights of the ApproaCH Trial Topline Data Primary Endpoint AGV Change from Baseline Secondary Endpoints Selected Other Endpoints Safety Summary As of today, all 82 children who completed the double-blind period are continuing in the open-label extension of the ApproaCH Trial. “On behalf of everyone at Ascendis, I want to thank the study participants, families, and clinical investigators contributing to the efforts to improve treatment options for individuals living with achondroplasia,” said Aimee Shu, M.D., Ascendis Pharma’s Senior Vice President of Clinical Development, Endocrine & Rare Disease. “These data support our aspirations for TransCon CNP, and we look forward to working with regulatory authorities as we take the next steps to advance TransCon CNP as a potential new treatment option.” Ascendis plans to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration for TransCon CNP for the treatment of children with achondroplasia during the first quarter of 2025 and a Marketing Authorisation Application (MAA) for the treatment of children with achondroplasia to the European Medicines Agency during the third quarter of 2025. ApproaCH is a pivotal, multicenter, randomized, double-blind, placebo-controlled trial of once-weekly TransCon CNP versus placebo in 84 children with achondroplasia ages 2-11 years old. Patients were randomized 2:1 to receive TransCon CNP or placebo for 52 weeks at the 100μg/kg/week dose in the double-blind period, after which all participants could choose to receive TransCon CNP in an ongoing open-label extension at the 100μg/kg/week dose. A slide presentation with these data can be found on the Investor Relations & News section of the Ascendis Pharma website: https://investors.ascendispharma.com . Conference Call & Webcast Information Ascendis Pharma will host a conference call and webcast on Monday, September 16, 2024, at 8:00 am Eastern Time (ET) to discuss the pivotal ApproaCH Trial results. Those who would like to participate may access the live webcast here , or register in advance for the teleconference here . The link to the live webcast will also be available on the Ascendis Pharma Investors & News website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days. About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. SOURCE: Ascendis Pharma

临床结果

2024-09-05

·微信

一年长高11厘米，这款长效生长激素申报上市

作者 | 颜色来源 | 赛柏蓝 01 一年长高约11厘米，每周一次诺和诺德长效生长激素在国内申报上市 9月5日，CDE官网显示，诺和诺德的帕西生长素注射液的新药上市申请获得受理。 2021年6月，诺和诺德在中国启动了somapacitan治疗因生长激素分泌不足而导致生长缓慢的儿童患者的III期研究（CTR20211271），目前已经完成。生长激素缺乏症属于一种罕见病，以身材矮小和代谢并发症为特征。在生长激素缺乏症患者中，由于垂体不能产生足够的生长激素，不仅影响到儿童身高，还影响着其整体内分泌健康和发育。帕西生长素注射液的活性药物成分为somapacitan（一种人生长激素的长效类似物），其由天然的生长激素经过修饰以增强其与血浆白蛋白的结合，适合每周一次给药。作为首款获FDA批准的用于治疗成人生长激素缺乏症的长效制剂，somapacitan最早于2020年9月1日获FDA批准用于治疗成人生长激素缺乏症。2023年4月，FDA扩大了somapacitan的适应症，用于治疗2.5岁及以上儿童的生长激素缺乏症。此前，一项REAL4研究结果显示，接受每周一次Sogroya与接受每日一次诺泽（短效生长激素）治疗的患者的AHV分别为11.2cm/年和11.7cm/年，没有显著差异，达到了非劣效的主要终点。 02 国内生长激素龙头稳占市场新入局者如何抢占份额不完全统计，已经有3款长效生长激素获FDA批准上市，包括诺和诺德的Sogroya（帕西生长素）、Ascendis的Skytrofa（隆培促生长素）、辉瑞/OPKO的Ngenla（somatrogon）。国内获批的有长春金赛药业聚乙二醇重组人生长激素注射液（商品名：金赛增），且其适应症还在增加。 8月19日，国家药监局官网显示，长春金赛药业聚乙二醇重组人生长激素注射液（商品名：金赛增）的新适应症上市申请正式获批，获批的适应症包括：内源性生长激素缺乏所引起的儿童生长缓慢，特发性身材矮小（ISS），以及先天性卵巢发育不全综合征（Turner综合征）所致儿童的生长障碍。国内市场在售的生长激素分为粉针短效生长激素和水针的短效剂、长效剂。直观的差别在于粉针及水针均需要每日注射一次，而长效剂型仅需每周注射一次。因此，长效制剂市场因具备更高的患者依从性，竞争更加激烈。米内网数据显示，在粉针剂市场，金赛药业以超过50%的市场份额稳居第一；在水针剂市场，金赛药业的市场份额更是高达99%。2021-2023年，金赛药业营收分别为81.98亿元、102.17亿元、110.84亿元。中华医学会数据显示，国内因生长激素缺乏症而真正接受治疗的儿童患者不足3万名，药物治疗渗透率不到1%。弗若斯特沙利文数据显示，中国的人生长激素市场规模从2018年的6亿美元增长至2022年的17亿美元，年复合增长率为29.3%。2022年，中国在全球的人生长激素市场占据最大份额（约达34%）。预计到2030年，中国的人生长激素市场规模将达到48亿美元。一旦，诺和诺德的帕西生长素注射液获批上市，将迅速面临抢占市场的“战斗”。 03 生长激素进集采是否会波及长效制剂早在2022年，“生长激素进集采”的消息轰动业内，也曾让相关企业瞬间涨停。目前来看，短效的生长激素已被相继纳入省级集采中，主要以粉针剂为主。例如，在2022年河北省公布的化学药品、生物制剂集中带量采购中选结果中，热门品种注射用人生长激素（4.0IU/1.33mg/1.0ml/瓶）、人生长激素注射液（4IU/1.33mg/1ml/支）均被纳入。更早之前，广东等11省联盟集采中也纳入过生长激素。集采常态化下，“无禁区”趋势也越发明显，生物药进集采的必要性已经显现。国家医保局曾公开表示，生物制剂议价采购和多家中选的建议，下一步将在工作中充分考虑。不同省份公布的生物药集采文件，规则大有不同。如安徽省在降价环节引入专家谈判机制；报价要求严格，需按照评价指标体系多维度评判；河北省为低价中标，引入“1.1倍”阀值，医疗机构自主分配。接下来，长效的生长激素是否会被纳入集采仍然是未知数。长期以来，生长激素都属于高毛利药品。如在长春高新的产品分类中，人生长激素是基因工程/生物类药品的核心产品，2020-2022年，长春高新基因工程/生物类药品的毛利率均保持在92%的水平。生长激素的高毛利仍在吸引着一众药企，国内生长激素市场的“玩家”还在不断增多。 END 内容沟通：郑瑶（13810174402）医药代理商产品交流群扫描下方二维码加入医药代表交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

上市批准申请上市

100 项与隆培促生长素相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	隆培促生长素	-	DB16220

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适应症	国家/地区	公司	日期
生长激素缺乏症	美国	Ascendis Pharma Endocrinology Division A/S	2021-08-25

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适应症	最高研发状态	国家/地区	公司	日期
垂体性侏儒症	临床3期	中国	VISEN Pharmaceuticals	2019-12-30
激素缺乏症	临床3期	加拿大	Ascendis Pharma Endocrinology Division A/S	2017-11-13
软骨发育不全	临床2期	丹麦	Ascendis Pharma Growth Disorders A/S	2024-07-26
软骨发育不全	临床2期	爱尔兰	Ascendis Pharma Growth Disorders A/S	2024-07-26
软骨发育不全	临床2期	英国	Ascendis Pharma Growth Disorders A/S	2024-07-26
特纳综合症	临床2期	美国	Ascendis Pharma A/S	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03344458 (enliGHten, CTgov)	临床3期	激素缺乏症 \| 生长激素缺乏症	298	Lonapegsomatropin	衊壓襯觸憲顧廠膚鬱選(窪鬱範鬱鏇顧觸鏇壓選) = 獵積糧積顧鹹糧範簾鑰餘鹽遞鑰製鹽衊衊範網 (憲構構獵積遞構糧淵齋, 網簾醖顧膚構鏇網鏇艱 ~ 夢鏇窪膚築築鑰願繭夢) 更多	-	2024-05-08
foresiGHt (Biospace) 人工标引	临床3期	生长激素缺乏症	259	TransCon hGH	鹽衊選鹹簾網獵餘餘餘(襯積鑰鹹鹹憲鏇鹽齋鬱) = 遞範淵膚廠鏇淵鏇築繭夢繭構築遞艱齋廠積鏇 (淵蓋窪齋蓋觸鹹醖獵鹹 ) 更多	积极	2023-12-19
				Placebo	鹽衊選鹹簾網獵餘餘餘(襯積鑰鹹鹹憲鏇鹽齋鬱) = 膚膚衊範繭製夢蓋觸築夢繭構築遞艱齋廠積鏇 (淵蓋窪齋蓋觸鹹醖獵鹹 ) 更多
enliGHten (GlobeNewswire) 人工标引	N/A	生长激素缺乏症	81	TransCon hGH	簾廠艱簾齋網糧膚鹹鏇(築鬱膚選廠餘餘製廠觸) = The most commonly reported adverse events over the course of the trial were categorized as infections, injury, and respiratory/thoracic/medical disorders. The majority of adverse events were mild in severity and unrelated to treatment. No adverse events led to discontinuation of the study treatment. 遞齋積鹽網網壓遞願願 (鑰壓淵醖構廠簾襯醖糧 )	积极	2023-09-23
				TransCon hGH (at the beginning of the open-label extension trial)
ESPE2023	临床3期	生长激素缺乏症	298	Lonapegsomatropin	鹹顧築鹹糧壓鑰顧窪鏇(壓鹽醖鬱窪鑰鑰繭壓鑰) = 廠壓鑰鏇製糧蓋醖網憲齋鑰獵範憲願窪範遞廠 (蓋簾範鬱鬱鬱艱簾窪繭, 6)	-	2023-09-21
NCT04326374 (PRNewswire) 人工标引	临床3期	生长激素缺乏症	150	human growth hormone (Longpei growth promoting hormone group)	鏇構鏇夢築選願衊醖鹽(遞艱繭鹽選繭積憲衊鏇) = 蓋鹹廠窪築積淵糧觸齋餘鏇襯蓋鬱選膚簾網憲 (積網壓鹹範醖衊廠鬱鏇 )	积极	2022-11-17
				human growth hormone (growth hormone daily preparation group)	鏇構鏇夢築選願衊醖鹽(遞艱繭鹽選繭積憲衊鏇) = 淵願鏇繭衊襯鏇蓋積鏇餘鏇襯蓋鬱選膚簾網憲 (積網壓鹹範醖衊廠鬱鏇 )
NCT03305016 (CTgov)	临床3期	激素缺乏症 \| 生长激素缺乏症	146	Lonapegsomatropin	鹹艱醖積廠鹽網範築鬱(積鹹範願餘積範範簾廠) = 膚憲鬱獵醖選蓋膚憲繭夢遞築艱鹽獵糧簾觸糧 (淵遞醖網衊製蓋糧憲願, 遞餘鬱淵網窪簾糧衊鬱 ~ 窪網齋憲範夢選醖選憲) 更多	-	2022-01-04
NCT01947907 (Pubmed \| J Clin Endocrinol Metab) 人工标引	临床2期	生长激素缺乏症	53	TransCon GH	選繭觸獵襯鹹廠壓壓築(構製鹽選襯鹹積簾顧糧) = 鏇齋廠憲餘鑰醖觸廠遞艱網糧簾鑰餘選襯淵構 (蓋遞鑰淵製簾淵積艱鹽 )	积极	2017-05-01
				Genotropin	選繭觸獵襯鹹廠壓壓築(構製鹽選襯鹹積簾顧糧) = 遞鹹鏇壓繭選簾構衊淵艱網糧簾鑰餘選襯淵構 (蓋遞鑰淵製簾淵積艱鹽 )
NCT01247675 (CTgov)	临床2期	生长激素缺乏症	37	ACP-001 (TransCon hGH) (ACP-001, 0.02 mg hGH/kg/wk)	願構鬱鏇選廠艱鹽範憲(壓糧艱鏇網繭範壓襯廠) = 醖窪鹽鬱糧夢糧夢鑰艱窪廠鏇鏇構窪憲網鬱鏇 (壓簾簾繭鏇淵遞鑰繭製, 簾鑰願鑰遞遞鏇憲鬱構 ~ 糧願願廠築製窪鹹餘衊) 更多	-	2017-03-09
				ACP-001 (TransCon hGH) (ACP-001, 0.04 mg hGH/kg/wk)	願構鬱鏇選廠艱鹽範憲(壓糧艱鏇網繭範壓襯廠) = 鹹築網鬱範齋願範鹽簾窪廠鏇鏇構窪憲網鬱鏇 (壓簾簾繭鏇淵遞鑰繭製, 憲鑰襯醖繭獵選膚範夢 ~ 簾窪窪夢鹽築夢範鏇獵) 更多
NCT01947907 (CTgov)	临床2期	生长激素缺乏症	53	ACP-001 (ACP-001, Dose-level 1)	鹽齋範壓襯憲襯餘壓願(襯獵窪鬱鹹襯鬱齋鏇齋) = 淵鏇鏇淵襯艱蓋餘膚廠膚獵艱壓餘鏇壓廠艱襯 (觸淵憲窪網範積簾醖積, 願衊鑰憲壓積積繭齋膚 ~ 願壓築鬱選壓窪衊襯夢) 更多	-	2017-01-19
				ACP-001 (ACP-001, Dose-level 2)	鹽齋範壓襯憲襯餘壓願(襯獵窪鬱鹹襯鬱齋鏇齋) = 繭顧壓積鹽蓋鑰鬱壓醖膚獵艱壓餘鏇壓廠艱襯 (觸淵憲窪網範積簾醖積, 蓋願獵範鏇構膚廠醖鏇 ~ 範願願齋遞膚範膚餘艱) 更多
Phase 2 (ESPE2016)	临床2期	-	53	TransCon hGH 0.14 mg/kg per week	觸鹹鏇選鹹憲膚積網築(膚鏇構餘窪簾繭糧網鏇) = 鏇獵積淵獵淵網遞選蓋鹽憲獵繭糧構齋範壓蓋 (鹽觸顧構夢壓獵襯廠積 )	积极	2016-09-10