A Proof-of-concept Study to Assess the Effect of Recombinant Human Growth Hormone on the Size of the Replication-competent Viral Reservoir in HIV-infected Individuals on Suppressive Antiretroviral Therapy

Antiretroviral therapy (ART) has improved the health of more than 18 million people infected with HIV by controlling viral replication, AIDS and non-AIDS events, and by reducing the risk of transmission. However, the existence of latent viral reservoirs in long-lived memory CD4 T cells remains a hurdle to curing HIV infection; consequently patients must remain on ART for the rest of their lives. Recently, a more realistic approach under limelight is to identify strategies leading to a functional cure, which is defined as the natural control of viral reservoir by the host. Use of recombinant human growth hormone has been shown to improve immune function by several mechanisms. This study hypothesizes that treatment with recombinant human growth hormone will decrease the size of the replication competent HIV reservoir in HIV-infected immune-reconstituted individuals.
The specific study objectives include:
To evaluate the effect of recombinant human growth hormone administration for 48 weeks on the size of the replication competent HIV reservoir
To evaluate the safety and tolerability of recombinant human growth hormone administration for 48 weeks in HIV-infected individuals on suppressive ART.
For this purpose, the investigators will add recombinant human growth hormone treatment for the patients receiving stable ART. Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada), which will last about 52 weeks. Participants will be treated with recombinant human growth hormone for a total of 48 weeks. The initial recombinant human growth hormone dose will be 3 mg/day (30-40 µg/kg/d) for 24 weeks administered by subcutaneous injection on an outpatient basis, followed by dose reduction to 1.5 mg/day for the final 24 weeks of the treatment period, also conducted on an outpatient basis. The study inclusion criteria include male and female participants, ≥18 and <40 years of age, with an undetectable viral load (the quantity of the HIV virus in the blood must be less than 50 copies/ml) during last 24 months and with a CD4 T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. The findings from this study will contribute to the development of novel strategies to eradicate HIV.

开始日期2016-12-01

申办/合作机构

Centre universitaire de santé McGill

[+1]

NCT01746862 / Completed临床3期

A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen® 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature

This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).

开始日期2012-12-01

申办/合作机构

Merck KGaA

NCT01616225 / Terminated临床2/3期IIT

Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study

This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.
We hope that our Adjuvant Growth Hormone study will help answer these questions.

开始日期2012-06-01

申办/合作机构

Pacific Center For Reproductive Medicine

[+1]

100 项与生长激素(Merck Serono SA) 相关的临床结果

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项与生长激素(Merck Serono SA) 相关的文献（医药）

2024-08-22·Studies in health technology and informatics

Preferences for Injection Device Settings and the Association with Adherence to Growth Hormone Treatment in Patient with Growth Disorders

Article

作者: Koledova, Ekaterina ; van Dommelen, Paula ; Arnaud, Lilian ; Rivera-Romero, Octavio ; Zucchiatti, Chantal

Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is important to achieve positive growth and other outcomes in children with growth disorders. Automated injection devices can facilitate the delivery of r-hGH, injections of which are required daily for a number of years. The ability to adjust injection device settings may improve patient comfort and needle anxiety, influencing adoption and acceptance of such devices, thereby improving treatment adherence. Here, we present the results of a retrospective observational study which investigated the association between injection device settings and adherence in the first 3 months of treatment in patients with growth disorders. Patients aged ≥2 and <18.75 years of age at treatment start, with ≥3 months of adherence data from start of treatment with the third generation of the easypod® device (EP3; Merck Healthcare KGaA, Darmstadt, Germany) were selected (N=832). The two most chosen combinations of device settings at treatment start were the default settings for injection speed, depth and time, or a slow injection speed and default depth and time. These combinations also demonstrated the highest adherence rates (94% and 95%, respectively) compared to other device settings (89%). A higher proportion of patients with intermediate/low adherence in the first month of treatment (31%, n=18/59) changed the device settings during treatment compared with those with high adherence (16%, n=128/803) (p=0.005). The ability to adjust injection device settings offers a valuable opportunity for personalizing treatment, improving patient comfort and treatment adherence.

2023-05-18·Studies in health technology and informatics

Participatory Study to Explore Healthcare Professionals' Perceptions of a Connected Digital Solution for Adherence Monitoring of Recombinant Human Growth Hormone Treatment: Study Protocol and First Findings.

Article

作者: Felicia Faienza, Maria ; Koledova, Ekaterina ; Vergani, Edoardo ; Rivera-Romero, Octavio ; Zucchiatti, Chantal

Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is fundamental to achieve positive growth outcomes in children with growth disorders and to improve quality of life and cardiometabolic risk in adult patients affected by GH deficiency. Pen injector devices are commonly used to deliver r-hGH but, to the authors' knowledge, none is currently digitally connected. Since digital health solutions are rapidly becoming valuable tools to support patients to adhere to treatment, the combination of a pen injector connected to a digital ecosystem to monitor treatment adherence is an important advance. Here, we present the methodology and first results of a participatory workshop that assessed clinicians' perceptions on such a digital solution - the aluetta™ smartdot™ (Merck Healthcare KGaA, Darmstadt, Germany) - combining the aluetta™ pen injector and a connected device, components of a comprehensive digital health ecosystem to support pediatric patients receiving r-hGH treatment. The aim being to highlight the importance of collecting clinically meaningful and accurate real-world adherence data to support data-driven healthcare.

2021-05-01·Endocrine3区 · 医学

Impact of adherence on growth response during the first 2 years of growth hormone treatment

3区 · 医学

Article

作者: Beisti, Anunciación ; de Arriba Muñoz, Antonio ; Aizpún, José Ignacio Labarta ; Llovet, Enrique ; Muñiz, Vanesa Cancela ; Saez, José Juan Alcón

PURPOSE:

Adherence to growth hormone (GH) treatment impacts clinical outcomes. The aim of this study is to assess the impact of adherence to rhGH treatment (2 years) on auxological outcomes.

METHODS:

Multicentric, retrospective observational study in rhGH-naïve GHD/SGA children treated with Saizen® during ≥2 years. Growth response was assessed by evaluating the change in height standard deviation score (ΔH SDS) and the index of responsiveness (IoR). Adherence was monitored using EasyPod™ Connect device.

RESULTS:

A total of 110 patients (3 Spanish centers) were evaluable (GHD n = 76, SGA n = 34). Adherence was 95.6 and 93.9% (year 1, 2). SGA and GHD children showed an increase of 0.6 cm/year and 1.1 cm/year for each 10% adherence modification. Lower adherence was observed in patients with lower pretreatment height velocity (HV) and in patients whose parents had a lower level of education. A positive correlation between index of responsiveness (IoR) during the first and second years with HV SDS during the second year and between IoR2 and adherence (year 1, 2) was observed. The frequency of patients with HV > 1 SD was higher (p = 0.025) among patients with adherence >90%. The best model to predict the height gain(cm) reaching an adjusted R squared of 0.489 involved percentage of adherence, Tanner stage, pretreatment HV, dose of rhGH, and whether the treatment was initiated before or after puberty.

CONCLUSIONS:

Adherence during the first 2 years of response was very high >90% and showed a negative association with age, pretreatment HV and treatment duration and a positive correlation with the level of parent education.

项与生长激素(Merck Serono SA) 相关的新闻（医药）

2024-12-05

·凯莱英Asymchem

【关注】从GLP-1到生长激素：一个能低调狂奔的赛道

来源：深蓝观 2024年无疑是多肽类药物的大年。在当下一个景气度不算高的时代下，GLP-1类药物先后推动了诺和诺德以及礼来两大超级MNC继续维持高速增长，同时也带动了以药明康德、诺泰生物为代表的供应链上企业业务的飞速向前。 GLP-1从大类上归属于内分泌疾病用药。这个治疗领域曾经因为一个单独的糖尿病市场成为各大药企必争之地，如今又借助减肥这个赛道再次成为全球制药行业的焦点，牵动着各家制药公司的神经。事实上，除了肥胖和糖尿病，内分泌领域仍存在巨大未被深入关注的疾病治疗需求。因为体内激素分泌紊乱引起的疾病有170多种，涉及发育异常、遗传、酶缺陷、炎症等多种临床综合征，这两年很火的用于治疗儿童生长发育迟缓的生长激素也属于该领域。由于内分泌疾病的治疗周期长，患者长期用药的依从性成为该领域一个重要的未被满足的治疗需求，这使得从每天一次到每周一次甚至更长时间的给药周期成为该领域药物研发、创新的趋势。据弗若斯特沙利文数据，中国的非糖尿病类内分泌药物市场规模预计到2026年将增至420亿人民币，自2022年起的年复合增长率为20.99%；并且到2030年将增至742亿人民币，自2026年起的年复合增长率为14.15%。这背后是在新一轮创新机制与分子机理迭代之后，使得过去内分泌赛道里许多未被挖掘的治疗需求重新迎来曙光，也推动着内分泌药物市场再次走向高光时刻。而立足于新技术去发掘、并解决一个领域里未被关注但存在巨大未满足需求，这是制药公司的宿命，也是成就自身的必经之路。而愿意在一个既定的赛道里扎根的选手，往往能更多地去抓住这方面的机会。 -01- 临床需求：永无止境临床上，医生总归是遵循指南去治疗患者，时间一长，对于指南内容的依赖便容易“理所当然”。但事实上，任何一款疗法都有改进的空间，临床上的需求永无止境。由于指南制定需要依赖于严格设计的临床试验以及大量上市后真实世界的研究数据，这使得指南内容的更新往往落后于创新治疗方案的问世。更便捷的给药方式、更好的疗效，以及更高的安全性，这是大多数药物临床开发需要追求的三个方向。对于用药周期通常以年为单位的内分泌领域疾病尤为如此。拿生长激素治疗的疾病举例。生长激素可以用于治疗生长激素缺乏症、特纳综合征、努南综合征、Prader-Willi 综合征、特发性矮小等在内的10余种疾病。这个跟身高相关的细分赛道，曾经成就了长春高新3000亿的巅峰市值，但是在这样一个领域，仍有相当大的未满足临床治疗需求空间。一般而言，对于有生长激素适应症的患儿，注射生长激素需要在骨骺闭合以前（不同孩子闭合年龄不同，但通常为男孩15岁以前、女孩13岁以前）。然而，由于认知不够诊断较晚以及对生长激素的误解，许多患儿错过了最佳治疗时间，导致市场仍存在大量未满足的需求。而健康中国2030规划提出的“到2030年全国五岁以下儿童生长迟缓率从8.1%下降到5~7%”的目标，又从侧面反映出这一“生长迟缓”群体尚未被完全筛查出来接受规范化诊疗。而另一个最严峻的，就是依从性的问题。 2021年，知名咨询公司安永一则调研报告显示，全球范围内短效剂型生长素漏针情况达到三成以上，局部地区比如新西兰，每周漏一次的比例高达66%。无独有偶，一篇发表在《中国新药期刊》上的论文也显示，在国内虽然生长激素对于相关疾病的治疗已经很成熟，但每日注射不方便，独立且无人监督的青少年不依从率高达66% ~ 77%，并且，一线城市因为社会节奏快、工作生活繁忙，漏针情况往往更严重。依从性差、频繁漏针意味着治疗不规律或给药剂量不足，会导致疗效大打折扣，而疗效的打折又会进一步降低患者的用药信心，继而进入一个负循环。值得注意的是，儿童领域的内分泌疾病从来不只有“长不高”，在多种儿童内分泌疾病的治疗中均存在一个至关重要的治疗窗口期。这意味着，在治疗窗口期内及时且有效的治疗对于控制病情、促进康复至关重要。因此，对于这类疾病而言，患者的依从性——即患者是否能够按时、按量、正确地接受治疗——其重要性被进一步凸显，成为影响治疗效果的关键因素。然而，患者依从性差和频繁漏针所引发的“治疗不及预期”是必然的，也在长期困扰着临床医生和患者及其家庭。由此，医药企业也在积极从药物设计的角度探寻更优的解决方案，试图帮助患者应对治疗挑战。于是，研发长效制剂便成为解决问题的主流趋势。生长激素长效（周制剂）与非长效（日制剂）仅一字之差，但带来的依从性提升是革命性的，安永给出了这其中的差距：周制剂的使用患者在漏针这件事上的比例只有4%。长效生长激素能在疗效上给患者带来更多的获益，而目前国内矮小症患者及其家属对生长激素长效制剂的知晓率只有54%。因此，庞大的需求缺口和极为显著的认知差也令市场对生长激素长效制剂给出了相对乐观的预期。近年来，虽然围绕大小分子各种长效化的技术层出不穷，但整体而言，涉及到激素分泌的蛋白类药物的长效化手段相对有限得多，核心难点是在不影响基础药物的疗效和安全性的基础上实现长效化。还是以生长激素为例。过去生长激素长效制剂的设计主要有两种思路：一个是设计成“皮下储存包”的思路，让生长激素分子从皮下储存包缓慢而持续地释放并进入血液循环从而实现长效化；另一种则是通过分子修饰技术，增大活性药物（生长激素）的分子量，减缓其在体内被清除的速度，延长半衰期，从而减少给药频率。两种思路各有千秋，也都有其局限性。近些年，两条路上都有不少产品或走向临床，或上市后又迎来退市。如今在国内，只有长春高新旗下一款用聚乙二醇（PEG）修饰的长效生长激素上市应用。国内长效生长激素市场竞争格局（截至2024.9）市场呼吁更多创新疗法上市，制药公司们也在相互角力。但一款长效生长激素产品能否成功走出来，还是要靠临床数据说话。 -02- 技术更迭背后的治疗革命 2022年11月，一家专注非糖尿病内分泌领域的创新药公司维昇药业发布了其新型长效生长激素周制剂——隆培促生长素（lonapegsomatropin）的三期临床试验结果：数据显示针对国内生长激素缺乏症的儿童52周的治疗后，其年化生长速率（AHV）达到10.66厘米，在统计学意义上显著优效于对照组生长激素日制剂（AHV=9.75厘米）。这是全球目前唯一一款有临床数据证实其疗效优于生长激素日制剂、且安全性良好的长效制剂。这意味着，相比使用日制剂，隆培促生长素不仅可以大大减少注射频率，还能达到更好的长高疗效。隆培促生长素引进自海外Biotech—— Ascendis Pharma，其海外商品名为Skytrofa，已分别于2021和2022年获得FDA以及EMA批准上市，用于治疗儿童生长激素缺乏症，是目前美国使用最广泛的长效生长激素。和其它长效生长激素设计思路不同，隆培促生长素基于“TransCon（暂时连接）”创新技术平台研发的长效控释技术，通过独特的连接结构将惰性载体分子与有生物学活性的生长激素分子暂时连接形成前药，前药进入血液循环后在生理PH值和体温条件下，连接结构可以特定速率自动解离，将未经修饰的天然结构的生长激素分子以可控的速度缓慢释放，进而发挥其生理作用。 TransCon技术原理这种连接技术，既解决了“皮下储存包”技术可能造成的注射部位不适以及活性药物释放不稳定等问题；又因为其活性药物为天然结构的原型药物分子，解决了由分子修饰技术导致的局限性，如分子修饰技术改变了原型药物分子结构和作用机理，从而可能带来对疗效、安全性以及长期用药对代谢的影响。基于TransCon技术平台开发的隆培促生长素，其核心优势是：在实现长效化的同时，其活性药物分子与人体自身分泌的天然生长激素完全一致，可基于内源性生长激素的模式发挥生理作用，这种“天然作用”确保了其有效性和安全性。维昇药业由技术方Ascendis和知名医药VC维梧资本共同孵化，将Ascendis的TransCon技术和三款内分泌药物带到中国，一路受到红杉、奥博、夏尔巴等知名创投基金的青睐。这三款药物都是基于TransCon技术平台孵化。绝大多数内分泌激素为肽类激素，或分子量偏小的蛋白质。其中部分肽类激素体内半衰期只有几分钟，从药物设计的角度来讲很难在保留生理活性的前提之下成药。而该技术平台，就像一层“糯米纸”，把被包裹和保护的原型药物分子送到体内，可大大降低其在体内被清除的速度，实现长效化，再通过缓慢而稳定释放的未经修饰的原型药物发挥和内源性激素相同的生理作用，因此尤适用于内分泌领域。目前维昇药业的三款产品均已完成关键临床阶段，在研发阶段已开始就中国现有诊断及治疗可改善的领域，分别和相关的医疗机构、医学协会、疾病公益及患者组织达成合作，共同推动疾病认知和管理水平的提高。此外，公司还携手和睦家，与这一国内知名非公医疗机构达成战略合作，开启共同探索以提升中国儿童生长发育服务为目标的创新发展模式，更广泛的推动儿童生长发育领域疾病诊疗水平的高质量发展。这些在研发阶段就开始对整个疾病领域医患需求的高度关注和教育布局，为公司在整个内分泌领域长期耕耘打下了坚实基础。制药是一个临床研究结果决定一切的行业。用一个全新的技术在一个既定的治疗领域里驰骋，从而完成市场主角的更迭。比如替诺福韦对旧一代核苷类药物的替代；比如靶向肿瘤药对放化疗的革命；新一代EGFR-TKI的出现让一代药物再无立锥之地；mRNA技术出来后，传统的疫苗设计思路似乎要面临新一轮的抉择…… 这是过去几十年里制药行业里一直在发生的事情，也是全球制药企业TOP20榜单排名角逐激烈、交替轮回的本质原因。新的治疗革命颠覆旧有的临床指南，老一辈的企业必须不断进化才能避免被新生代力量所替代。医药行业里这种极其容易被“点状创新”所颠覆的现象，再加上行业里独有的专利悬崖效应，让时间从来都不是站在有规模、有先发优势的药企那一边。那么在这个行业，要如何去做“时间的朋友”？ -03- 快速迭代VS做精做专 MNC大厂自有大厂的办法。借助自己的战略团队不断去寻找未来五年的“重磅领域”，并用自身雄厚的财力用高规格的研发以及并购战略提前部署。当然这种“战略眼光”偶尔也看运气。比如辉瑞早在21世纪初就开始布局了ADC，眼光不可谓不超前，但终究是起了个大早，没赶上ADC的黄金发展时期便草草收场，以至于如今等到ADC领域爆发之后不得不再花重金来重新入局。默沙东是幸运的，对先灵葆雅“无心插柳”的收购，换来了自身在免疫治疗领域的统治地位；但BMS就差点运气了，虽然也拿到了O药，但除此之外的涉猎，均未得到太多的正反馈，同样剧情的还有罗氏，这两年肿瘤以及肿瘤外的布局终究是声音不太够…… 始终保持自身的王者地位毕竟要求过于高：超前的眼光、强大的外部合作实力（资金、业务规模）、以及快速的执行力，这三点缺一不可。国内的制药公司们，除了少数几家已经上岸的biotech和big pharma有实力可以参考上述路径之外，大多数企业只能在跟随的脚步里，用更勤奋和更内卷的脚步去追赶。“me too”或者“fast follow”的好处是能对标世界前沿，但有时候企业也得评估自己的风险承受能力，大厂押错一个赛道只是发展脚步放缓，但小公司们选错路通常是伤筋动骨。无论是在不同的赛道里不断去押注“未来的热点”，还是用追赶的脚步去跟随当下的热点，这些都需要时代下的一些运气。而对于一些没吃到时代红利、仍在慢慢积累的年轻制药公司来讲，还有另外一条路可以走，就是在一个既定的领域里扎根做到极致。这两种模式一个很大的区别就是，前者是产品先行，而后者，往往是领域先行。在一个固定的领域里，开发/临床/商务/运营体系可以复用，平台技术和产品之间相互协同、相互赋能，用极致的效率去将资源最大化。不会因外界热点的影响而导致动作变形，而是可以在一个足够大的市场里持续挖掘且不惧周期的波动。回到内分泌领域，这是一个覆盖从新生儿到老年人全年龄段人群、且将近一半疾病目前仍旧存在无药可医、用药周期长、存在巨大未被满足临床需求等问题的治疗领域。比如维昇药业三款核心产品专注的细分领域，除了生长激素缺乏症之外，甲状旁腺功能减退症目前在我国患者规模接近40万，是目前唯一一种缺少激素替代疗法的内分泌疾病，治疗手段相当局限。而软骨发育不全作为一种染色体遗传疾病，全球发病人数约36万，患者往往身材矮小且伴随多种骨骼并发症。这种疾病对生长激素应答不佳，且手术治疗有着巨大的风险和痛苦的治疗过程，在2023年9月被国家卫健委纳入了《第二批罕见病目录》。因此，内分泌领域未满足的临床治疗需求同样巨大。绝大多数内分泌疾病治疗周期长，即使去掉糖尿病和当前火热的减肥药赛道，每年各细分疾病领域里仍有大量的新发患者；不同疾病之间又易产生关联，都与各种内分泌激素调控紊乱有关。这一领域的研发壁垒也不容小觑。与激素调控相关的药物设计难度不亚于肿瘤，且该类药物多为生物制剂，对安全性和稳定性要求更高。这更是一个足以撑起一家公司救死扶伤使命的赛道，维昇正用创新技术践行这一使命。只有扎根下去，才能更快洞察到这个领域里的各种未被满足的需求，才能用更新的技术去转化革命性的治疗手段，也才能将创新治疗产品带给更多需要的患者。

2024-08-01

·Insight数据库

默克上半年财报：制药业务收入超 41 亿欧元；肿瘤产品收入增长超 14%

8 月 1 日，德国默克（Merck KGaA）发布了 2024 年第二季度和上半年财报。该集团所有业务净销售额增长 1.7% 至 54 亿欧元。其中，该公司的制药业务（Healthcare）第二季度销售额为 21.37 亿欧元，增长 5.3%；上半年销售额为 41.84 亿欧元，增长 7.6%。报告指出，这一增长主要得益于肿瘤、心血管、代谢和内分泌学领域的收入增长。肿瘤领域肿瘤业务第二季度收入为 4.9 亿欧元，增长 9.2%；上半年收入为 9.9 亿欧元，增长 14.1%。截图来自：默克财报 Erbitux（西妥昔单抗）在肿瘤领域，EGFR 单抗 Erbitux 仍然是默克最畅销的抗癌药物，该药第二季度销售额为 2.76 亿欧元，增长 8.2%；上半年销售额为 5.63 亿欧元，增长13.6%。根据报告，Erbitux 二季度销售额的强劲增长主要得益于欧洲、拉丁美洲和亚太地区的增长。西妥昔单抗是 EGFR 表达、RAS 野生型转移性结直肠癌以及复发性和/或转移性和局部晚期头颈部鳞状细胞癌患者的标准治疗。目前，默克开展了近 200 项涉及西妥昔单抗的活跃临床试验，包括超 15 项 III 期研究。 Bavencio (Avelumab) 抗 PD-L1 抗体 Bavencio 第二季度销售额为 1.86 亿欧元，增长 6.4% ；上半年销售额为 3.72 亿欧元，增长 10.2%。Bavencio 在第二季度的稳健增长主要得益于除北美以外的所有其它地区的收入贡献。 Bavencio 已获准在 70 多个国家/地区作为晚期尿路上皮癌的一线维持治疗。根据 JAVELIN Bladder 100 试验的结果，它已成为治疗这种疾病的标准治疗。Bavencio 还获准与阿昔替尼联合用于晚期肾细胞癌的一线治疗，并且是转移性默克尔细胞癌（一种罕见皮肤癌）的单药疗法的标准治疗。其它肿瘤管线进展默克也披露了该公司肿瘤领域其它产品管线的进展。其中，口服 MET 抑制剂 Tepmetko(Tepotinib) 已在全球约 40 个市场上市，其它市场的监管申请正在审评查中。今年 2 月份，FDA 正式批准了 Tepmetko（此前该药物已获 FDA 加速批准）。今年 6 月，默克宣布停止了 IAP 抑制剂 Xevinapant 的随机 III 期 TrilynX 研究，该研究旨在评估 xevinapant 联合放化疗对未切除局部晚期头颈部鳞状细胞癌 (LA SCCHN) 患者的疗效。xevinapant 的另一项 III 期临床试验 XRay Vision 也已停止，该研究旨在评估 xevinapant 联合放疗对已切除 LA SCCHN 患者的疗效。 2024 年上半年，默克还在 ASCO 年会上以口头报告的形式介绍了抗 CEACAM5 抗体-药物偶联物 (ADC) M9140 在晚期结直肠癌中的 Ia 期研究结果。这是默克开发的第一个进入临床开发的 ADC，目前已进入到结直肠癌的 Ib 期阶段。此外，在 DNA 损伤反应 (DDR) 产品组合中，默克表示将继续推进 ATR 抑制剂 Tuvusertib (M1774) 的开发。该公司正在三项 II 期临床研究中探索 Tuvusertib 的四种组合，涉及适应症包括非鳞状非小细胞肺癌、PARP 抑制剂抗药性卵巢癌、晚期尿路上皮癌。神经病学和免疫学领域神经病学和免疫学产品第二季度销售额为 4.34 亿欧元，下降-7.4%；上半年销售额为 8.53 亿欧元，与去年同期基本持平。截图来自：默克财报在神经病学和免疫学领域，默克目前的产品组合包括两种用于治疗复发性 MS (RMS) 的获批产品 ---- Rebif（干扰素 β-1a）和 Mavenclad（克拉屈滨片）。 Rebif 是一种改善病情的药物，20 多年来一直是 RMS 的标准治疗方法。该药 Q2 销售额为 1.68 亿欧元，下降-18.5% ；上半年销售额为 3.26 亿欧元，下降 -9.0% 。报告指出，Rebif 二季度销售额的下降是由于干扰素市场持续激烈的竞争所致，以及口服剂型和高效 MS 疗法的竞争，预计未来这些因素将会导致该药的销售额进一步下降。 Mavenclad 是一种用于治疗各种形式的高活性 RMS 成人患者的短期口服疗法，已在全球 95 个国家/地区获得批准，包括欧盟、瑞士、澳大利亚、加拿大和美国。该药第二季度销售额为 2.66 亿欧元，增长 1.3% ；上半年销售额为 5.27 亿欧元，增长 6.5% 。除了 MS，默克表示还将继续扩大神经病学和免疫学领域的产品，为医疗需求尚未得到满足的患者开发潜在 first-in-class 疗法。2023 年 6 月，FDA 授予一种用于治疗重症肌无力的口服克拉屈滨（Cladribine）新配方孤儿药资格。默克已于 2024 年 6 月启动了一项全球 III 期临床试验。此外，默克开发的 Enpatoran 是一种 Toll 样受体 7 和 8 (TLR7/8) 抑制剂，处于 II 期临床开发阶段。默克预计 Enpatoran 在皮肤型红斑狼疮和系统性狼疮中的 II 期结果将于 2025 年初公布。心血管、代谢和内分泌学心血管、代谢和内分泌领域产品组合包括 Glucophage、Euthyrox、Concor 和 Saizen 等药物，是默克制药业务部门销售额最大的版块。该领域业务第二季度销售额为 7.46 亿欧元，增长 13.7%；上半年销售额为 14.35 亿欧元，增长 8.9%。截图来自：默克财报 Glucophage 含有活性成分二甲双胍，是治疗 2 型糖尿病的一线药物，在 100 多个国家有售。该药二季度销售额为 2.38 亿欧元，增长 23.5% ；上半年销售额为 4.59 亿欧元，增长 13.8% 。 Concor 含有比索洛尔，它是一种 β 受体阻滞剂，用于治疗高血压和心血管疾病。除了 Concor/Concor Cor，Concor 系列还包括固定剂量组合，例如 Concor Plus/Lodoz（比索洛尔与氢氯噻嗪）。Concor 第二季度销售额为 1.58 亿欧元，增长 13.2% ；上半年销售额为 2.97 亿欧元，增长 7.4%。 Euthyrox 含有活性成分左旋甲状腺素，是治疗甲状腺功能减退症的药物。该药二季度销售额为 1.55 亿欧元，增长 19.2% ；上半年销售额为 2.94 亿欧元，增长 14.1%。 Saizen 含有活性成分生长激素，是默克的主要内分泌产品，用于治疗儿童和成人的多种生长激素紊乱。该药二季度销售额为 9700 万欧元，增长 23.0% ；上半年销售额为 1.86 亿欧元，增长 20%。参考资料：Merck Returns to Organic Sales Growth. https://www.merckgroup.com/en/news/q2-2024-01-08-2024.html 封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期财报ASCO会议抗体药物偶联物加速审批

2024-05-14

·Merck Group

Off to a Good Start in Fiscal 2024

Financial results of Q1 2024 Healthcare with strong performance Electronics increases sales and earnings organically, driven by higher demand for semiconductor materials Inventory destocking in Life Science continues; sales recovery expected in the second half of the year Net sales down organically by 1.2% to € 5.1 billion EBITDA pre decreases organically by 5.2% to € 1.5 billion Forecast for fiscal 2024 Qualitative guidance confirmed with Group returning to organic growth Net sales: in a range of € 20.6 billion to € 22.1 billion, organically +1% to +5% EBITDA pre: in a range of € 5.7 billion to € 6.3 billion, organically +1% to +7% Merck KGaA, Darmstadt, Germany, a leading science and technology company, has had a good start to fiscal 2024. The Healthcare business sector performed strongly. Electronics also delivered solid organic sales growth, mainly driven by Semiconductor Solutions. Life Science recorded sales and earnings declines compared with the particularly high base of the year-earlier quarter. In the first quarter of 2024, thanks to the sound business performance and compared with the high base of the first quarter of 2023, Group sales decreased by only 3.3% (organically: ‑1.2%) to € 5,120 million. Foreign exchange effects, mainly from the Chinese renminbi, had a negative impact of 2.0% on the sales development. EBITDA pre fell by 8.4% (organically: ‑5.2%) to € 1,454 million. Negative foreign exchange effects impacted EBITDA pre by 3.2%. The EBITDA pre margin was 28.4% in the first quarter of 2024 and earnings per share pre were € 2.06. “We had a good start to the year and gained initial momentum in the first quarter of 2024, once again benefiting from our diversified business model,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “We expect acceleration in the second half of the year, especially in Life Science, and thus a gradual return to organic growth for the Group in fiscal 2024.” Life Science: Decline in first quarter against high comparables, in line with expectation of a softer first half of the year Net sales of the Life Science business sector declined organically by 12.6% against the particularly high base of the first quarter of 2023. Foreign exchange had a negative impact of 1.2% on the sales development. Overall, sales of the business sector decreased by 13.8% to € 2,144 million in the first quarter of 2024. The main reason for this was the continued inventory destocking by customers of Process Solutions. Net sales of this business unit declined organically by 19.0%. As a positive signal, order income in Process Solutions increased sequentially as well as year-on-year. The company expects customers to reach their target inventory levels by the end of the second quarter of 2024. However, due to the manufacturing and delivery times for products ordered by customers, this will significantly increase sales only in the second half of the year. In addition to inventory destocking, the phase-out of Covid-19-related demand was also a headwind for the business development of Life Science in the first quarter of 2024. Compared with the high year-earlier figure, EBITDA pre of Life Science decreased organically by 30.3% and amounted to € 611 million. This was due, among other things, to the lower sales volume and the lower share of higher-margin products sold. The EBITDA pre margin of the business sector was 28.5%, a sequential increase against the 26.3% EBITDA pre margin in the fourth quarter of 2023. Healthcare: Double-digit organic sales growth of “Wave 1” products, further supported by strong performance of established product portfolio The Healthcare business sector performed strongly across all franchises in the first quarter of 2024 amid the market recovery in mainland China, where the year-earlier quarter had been adversely affected by the high rate of Covid‑19 infections. Sales of Healthcare rose organically by 10.1%. Including negative foreign exchange effects of 2.6%, sales increased overall by 7.5% to € 2,048 million. The “Wave 1” products Bavencio (+14.2%) and Mavenclad (+12.2%) achieved double-digit organic sales increases. The oncology drug Erbitux delivered very strong organic sales growth of 19.3%, boosted by the softer year-earlier comparables in mainland China. Net sales of the Fertility (+7.7%) and Cardiovascular, Metabolism & Endocrinology (+4.2%) franchises also rose organically. EBITDA pre of Healthcare went up organically by 28.3% to € 708 million, supported by the regaining of the exclusive worldwide rights to Bavencio and strong sales momentum. The EBITDA pre margin was 34.6%. Electronics: Positive start to the year, full market inflection still expected in the second half of the year Electronics delivered solid organic sales growth of 6.3%. This was particularly driven by Semiconductor Solutions, the sector’s largest business unit, which grew organically by 7.8%. The main reason for this was increased demand for certain semiconductor materials, for example materials used for leading-edge logic chips. However, the Group does not yet view this as a general inflection point, since demand in other end markets remained soft. The other two business units, Display Solutions (+4.2%) and Surface Solutions (+1.8%), also recorded organic sales increases. Amid negative foreign exchange effects of 3.2%, sales of the Electronics business sector rose overall by 3.1% to € 928 million. EBITDA pre increased organically by 3.9% compared with the year-earlier quarter. Due to negative foreign exchange effects of 4.2%, the earnings development saw a slight decline by 0.3% to € 237 million overall. The EBITDA pre margin of Electronics was 25.5%. Forecast for fiscal 2024: Qualitative guidance confirmed with Group returning to organic growth In fiscal 2024, Merck KGaA, Darmstadt, Germany, expects to return to organic sales and earnings growth for the Group. In particular, the company assumes the following development, in line with its qualitative guidance provided in March 2024: Net sales: in a range of € 20.6 billion to € 22.1 billion with organic growth of +1% to +5% and foreign exchange effects of ‑3% to 0%. EBITDA pre: in a range of € 5.7 billion to € 6.3 billion with organic growth of +1% to +7% and negative foreign exchange effects of ‑4% to ‑1%. EPS pre: € 8.05 to € 9.10. Overview of the key figures for Q1 2024 Group Key figures € million Q1 2024 Q1 2023 Change Net sales 5,120 5,293 -3.3% Operating result (EBIT) 1 931 1,035 -10.0% Margin (% of net sales) 1 18.2% 19.6% EBITDA 2 1,385 1,491 -7.1% Margin (% of net sales) 1 27.0% 28.2% EBITDA pre 1 1,454 1,587 -8.4% Margin (% of net sales) 1 28.4% 30.0% Profit after income tax 699 800 -12.5% Earnings per share (€) 1.60 1.83 -12.6% Earnings per share pre (€) 1 2.06 2.36 -12.7% Operating cash flow 1,035 853 21.4% Net financial debt 3 7,498 7,500 – Number of employees 4 62,345 64,011 -2.6% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Figures for the reporting period ending on March 31, 2024, prior-year figures as of December 31, 2023. 4 Figures for the reporting period ending on March 31, 2024, prior-year figures as of March 31, 2023. This figure refers to all employees at sites of fully consolidated entities. Life Science Net sales by business unit € million Q1 2024 Share Organic growth 1 Exchange rate effects Acquisitions/ divestments Total change Q1 2023 Share Science & Lab Solutions 1,169 55% -6.9% -1.5% – -8.4% 1,276 51% Process Solutions 817 38% -19.0% -1.1% – -20.0% 1,022 41% Life Science Services 157 7% -16.6% – – -16.7% 188 8% Life Science 2,144 100% -12.6% -1.2% – -13.8% 2,487 100% 1 Not defined by International Financial Reporting Standards (IFRS). Healthcare Net sales by major product lines/products € million Q1 2024 Share Organic growth1 Exchange rate effects Total change Q1 2023 Share Oncology 500 24% 19.3% -3.8% 15.5% 433 23% thereof: Erbitux ® 287 14% 19.3% -4.3% 15.0% 250 13% thereof: Bavencio ® 186 9% 14.2% -2.8% 11.4% 167 9% Neurology & Immunology 419 20% 8.8% -1.5% 7.3% 390 20% thereof: Mavenclad ® 261 13% 12.2% -2.0% 10.2% 237 12% thereof: Rebif ® 158 8% 3.7% -0.9% 2.8% 154 8% Fertility 383 19% 7.7% -3.3% 4.4% 366 19% thereof: Gonal-f ® 204 10% 6.8% -3.5% 3.3% 197 10% Cardiovascular, Metabolism and Endocrinology 689 34% 4.2% -2.4% 1.7% 677 36% thereof: Glucophage ® 221 11% 5.1% -3.7% 1.4% 218 11% thereof: Concor ® 140 7% 1.6% -3.6% -1.9% 142 7% thereof: Euthyrox ® 139 7% 8.9% -1.7% 7.2% 130 7% thereof: Saizen ® 89 4% 17.0% -0.2% 16.7% 76 4% Other 57 3% 38 2% Healthcare 2,048 100% 10.1% -2.6% 7.5% 1,905 100% 1 Not defined by International Financial Reporting Standards (IFRS). Electronics Net sales by business unit € million Q1 2024 Share Organic growth 1 Exchange rate effects Acquisitions/ divestments Total change Q1 2023 Share Semiconductor Solutions 633 68% 7.8% -3.0% -0.1% 4.7% 604 67% Display Solutions 187 20% 4.2% -4.3% – -0.1% 187 21% Surface Solutions 109 12% 1.8% -2.2% – -0.4% 109 12% Electronics 928 100% 6.3% -3.2% -0.1% 3.1% 901 100% 1 Not defined by International Financial Reporting Standards (IFRS). Notes to editors: The press conference for media representatives will take place at 9:30 a.m. (CEST). The respective presentation and further information for journalists, including a digital press kit , can be found here The quarterly statement can be found here Merck KGaA, Darmstadt, Germany, on LinkedIn Photos and videos can be found here Stock symbols Reuters: MRCG, Bloomberg : MRK GY, Dow Jones : MRK.DE Frankfurt Stock Exchange : ISIN : DE 000 659 9905 – WKN : 659 990 All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

财报

100 项与生长激素(Merck Serono SA) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
成长不全	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
性腺发育不全	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
生长迟缓	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
特纳综合症	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
短肠综合征	美国	EMD Serono, Inc.	2001-11-19
生长激素缺乏症	美国	EMD Serono, Inc.	1996-10-08
HIV感染	美国	EMD Serono, Inc.	1996-08-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
特发性矮小症	临床3期	韩国	Merck KGaA	2012-12-01
纤维肌痛	临床3期	西班牙	Merck KGaA	2007-12-01
垂体性侏儒症	临床3期	美国	EMD Serono, Inc.	2005-01-01
HIV相关性脂肪营养不良综合征	临床3期	美国	EMD Serono, Inc.	2004-05-28
HIV相关性脂肪营养不良综合征	临床3期	加拿大	EMD Serono, Inc.	2004-05-28
小于胎龄儿	临床3期	意大利	Merck KGaA	2004-02-01
胎儿生长受限	临床3期	-	Merck KGaA	1998-11-01
HIV消耗综合征	临床3期	-	EMD Serono, Inc.	1997-07-01
软骨发育不良	临床2期	法国	Merck KGaA	2006-03-21
生长障碍	临床1期	德国	EMD Serono, Inc.	2008-07-01

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临床结果

适应症

分期

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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


ESPE2019	N/A	软骨发育不良 FGFR3 mutation	-	Saizen (r-hGH, Merck France)	範繭襯製艱鬱觸鏇鬱觸(餘醖製築鬱憲壓憲淵淵) = 醖壓淵遞衊醖憲製範膚餘鬱糧顧衊繭壓獵齋齋 (夢繭鏇蓋廠觸襯鑰選窪 )	-	2019-09-19
				Growth Hormone (GH)	範繭襯製艱鬱觸鏇鬱觸(餘醖製築鬱憲壓憲淵淵) = 膚夢廠憲蓋艱糧鏇鬱蓋餘鬱糧顧衊繭壓獵齋齋 (夢繭鏇蓋廠觸襯鑰選窪 )
NCT00082628 (CTgov)	临床3期	HIV相关性脂肪营养不良综合征	326	Placebo (Period I: Placebo)	簾選觸範淵選鬱顧製簾(鹽鹹構夢鑰壓顧遞壓膚) = 鏇艱醖積夢鹹願廠築簾膚糧簾積衊繭淵鹹鑰範 (範構淵鑰廠顧餘鏇鏇齋, 選壓顧積構遞窪齋簾築 ~ 網餘顧餘範淵選蓋齋網) 更多	-	2018-07-20
				Serostim® 4 mg (Period I: Serostim® 4 mg)	簾選觸範淵選鬱顧製簾(鹽鹹構夢鑰壓顧遞壓膚) = 積顧觸網選蓋衊壓艱鏇膚糧簾積衊繭淵鹹鑰範 (範構淵鑰廠顧餘鏇鏇齋, 夢衊壓構觸鬱鬱觸齋簾 ~ 簾衊鬱獵鹽襯網壓願淵) 更多
NCT00256126 (CTgov)	临床4期	特纳综合症 \| 生长激素缺乏症	318	Saizen (Turner Syndrome (TS))	遞艱鑰鑰選廠糧淵簾艱(夢繭積齋窪積襯願鏇壓) = 顧顧廠艱積顧積鑰廠觸選廠膚簾襯壓願窪願醖 (顧範憲鹽觸齋顧簾簾窪, 製選齋遞憲壓膚築夢鏇 ~ 艱壓築衊鏇窪簾範蓋餘) 更多	-	2018-03-20
				Saizen (Growth Hormone Deficiency (GHD))	遞艱鑰鑰選廠糧淵簾艱(夢繭積齋窪積襯願鏇壓) = 夢夢艱築糧廠膚糧製願選廠膚簾襯壓願窪願醖 (顧範憲鹽觸齋顧簾簾窪, 鹽襯繭襯遞遞壓獵淵餘 ~ 餘艱簾艱蓋鹽襯願糧顧) 更多
NCT01746862 (SYNERGY, CTgov)	临床3期	特发性矮小症	90	Saizen® (Saizen Test Group)	蓋醖構襯淵糧窪製襯選(範鬱鹽構遞顧鬱鏇鏇築) = 簾築願鏇獵壓選鑰範鬱顧積鹹築鏇鏇築蓋製醖 (構襯獵繭糧積膚範製範, 衊構醖獵遞製製淵鑰構 ~ 鹽構獵衊鑰憲鹹簾鑰衊) 更多	-	2016-10-18
				Saizen® (Saizen Control Group)	蓋醖構襯淵糧窪製襯選(範鬱鹽構遞顧鬱鏇鏇築) = 鹽襯壓鬱選鏇製觸廠構顧積鹹築鏇鏇築蓋製醖 (構襯獵繭糧積膚範製範, 製艱遞壓艱獵齋網觸齋 ~ 製繭艱蓋顧襯廠壓網蓋) 更多
NCT00933686 (CTgov)	临床3期	功能障碍 \| 纤维肌痛	113	Saizen® (Saizen®)	醖顧糧積醖鏇鑰鹹願壓(鏇獵鬱夢衊夢廠齋鑰夢) = 夢糧鹹廠淵願廠壓窪齋餘餘鹹簾鬱淵淵憲醖築 (醖齋構簾壓糧艱築顧構, 顧選鑰鏇窪繭鹽顧鏇築 ~ 範鏇鹽簾鬱憲築鬱獵顧) 更多	-	2013-08-02
				Placebo+Saizen® (Placebo + Saizen®)	醖顧糧積醖鏇鑰鹹願壓(鏇獵鬱夢衊夢廠齋鑰夢) = 製遞繭壓積壓憲壓衊齋餘餘鹹簾鬱淵淵憲醖築 (醖齋構簾壓糧艱築顧構, 夢構繭蓋壓鏇積膚廠鹽 ~ 製簾積製觸選蓋觸遞網) 更多
NCT01237340 (CTgov)	临床3期	生长激素缺乏症	59	Saizen®	糧鑰獵願淵蓋壓築淵網(繭願鹹廠蓋簾鑰膚鏇顧) = 糧構願願襯鑰網衊願鑰獵襯鹹鑰築願繭獵衊觸 (膚窪蓋鹽夢觸鑰餘膚醖, 艱淵齋觸廠鹹顧顧糧淵 ~ 廠窪鏇積繭鹽襯構製選) 更多	-	2012-10-11
NCT00249821 (SGA OPTIMIS, CTgov)	临床3期	小于胎龄儿	22	Saizen® (Saizen® 0.057 mg/kg/Day)	襯網淵製廠憲繭選鬱鹽(構觸淵製製獵網憲願範) = 積蓋鏇鹽範願齋壓顧艱積獵窪齋積醖廠糧糧繭 (簾鑰鹽網餘顧簾淵艱鬱, 憲夢觸繭廠淵願蓋膚糧 ~ 積顧觸衊鹹鏇選積襯觸) 更多	-	2012-10-10
				Saizen® (Saizen® 0.035 mg/kg/Day)	襯網淵製廠憲繭選鬱鹽(構觸淵製製獵網憲願範) = 壓壓壓鏇憲鹹襯網衊鑰積獵窪齋積醖廠糧糧繭 (簾鑰鹽網餘顧簾淵艱鬱, 簾繭襯選艱憲鑰簾窪壓 ~ 積鬱鹹觸艱窪網襯鏇築) 更多
NCT00100698 (CTgov)	N/A	脂肪营养不良 \| 获得性免疫缺陷综合征	56	Growth Hormone (Recombinant Human Growth Hormone)	鬱獵衊遞選憲糧淵簾願(遞鬱醖獵顧構齋鬱窪醖) = 壓選夢網蓋選製鹽憲鏇觸鏇廠鹹鏇蓋鑰願構選 (鏇壓醖築築鹹構襯網淵, 鹽鏇製鹹糧範鏇網壓選 ~ 鹽糧艱積積壓鏇憲鑰襯) 更多	-	2010-07-22
				placebo (Placebo)	鬱獵衊遞選憲糧淵簾願(遞鬱醖獵顧構齋鬱窪醖) = 壓窪窪窪糧願艱構膚繭觸鏇廠鹹鏇蓋鑰願構選 (鏇壓醖築築鹹構襯網淵, 築糧襯簾顧選憲鑰選餘 ~ 構壓鹹廠夢製範餘艱繭) 更多
NCT00109733 (CTgov)	临床3期	垂体性侏儒症 \| 生长激素缺乏症	31	recombinant human growth hormone (Standard Dose Group)	鹽製遞鹹淵構鏇淵製願(糧醖鬱製鬱鏇製鑰夢願) = 範鹽艱夢憲願獵遞艱獵構淵選積選觸築膚齋製 (廠鹹淵襯網簾夢蓋鑰簾, 齋蓋顧淵積窪蓋選範積 ~ 積鏇顧積廠廠蓋醖顧積) 更多	-	2010-06-22
				recombinant human growth hormone (High Dose Group)	鹽製遞鹹淵構鏇淵製願(糧醖鬱製鬱鏇製鑰夢願) = 廠廠襯網觸積艱範遞鹹構淵選積選觸築膚齋製 (廠鹹淵襯網簾夢蓋鑰簾, 糧獵廠範構製蓋製憲簾 ~ 餘鏇製觸窪積齋淵鹹簾) 更多
IAS2004	N/A	脂肪营养不良 \| HIV感染	20	Recombinant growth hormone (Serostim)	餘淵獵簾範遞積齋鏇齋(網鬱膚製觸積鹹衊構築) = 獵齋構顧願繭齋鑰選鏇鬱鬱齋築艱鏇積鏇獵選 (壓鬱齋顧齋蓋鑰築鹽窪 ) 更多	积极	2004-01-01