A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a leading cause of End Stage Kidney Disease (ESKD) worldwide. Elevated levels of 3', 5' - cyclic AMP (cAMP) play a central role in the pathogenesis and progression of the disease. Vasopressin antagonists and somatostatin analogues, which indirectly reduce adenyl cyclase 6 activity, have been found to markedly reduce renal tubular cell proliferation and cyst growth in experimental models of ADPKD. In combination, the two treatments show a clear additive effect and may significantly reduce renal cystic and fibrotic volume as well as cAMP levels to wild type levels.
The vasopressin antagonist Tolvaptan and the somatostatin analogue Octreotide share a similar renoprotective effect also in human disease.
Both medications effectively slow total kidney and cystic volume (TKV and TCV, respectively) growth and glomerular filtration rate (GFR) decline in patients with ADPKD. The short-term effect of both medications appear to be larger when the GFR is normal or even higher than normal and kidney volumes are still relatively stable. On the basis of experimental data, it is conceivable that Tolvaptan and Octreotide LAR should have an additive effect also in human disease, during initial treatment as well as in the long-term. To address the working hypothesis of an additional short-term effect of Tolvaptan and Octreotide, we propose to run a pilot, explorative, randomized, placebo-controlled, clinical trial with a Cross-Over Design to compare the short-term effects of Tolvaptan monotherapy and Tolvaptan plus Octreotide LAR combination therapy on TKV as assessed by MRI, and on GFR as directly measured by the iohexol plasma clearance technique in ADPKD patients with normal (80 to 120 ml/min/1.73m2) kidney function or even kidney hyperfiltration (GFR ≥120 ml/min/1.73m2).

开始日期2018-12-12

申办/合作机构

Istituto di Ricerche Farmacologiche Mario Negri

[+1]

NCT03057509

/ Withdrawn临床1期IIT

A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors

This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors.

开始日期2018-11-01

申办/合作机构

The General Hospital Corp.

NCT02874326

/ Unknown status临床2期IIT

An Uncontrolled, Pilot-study Assessing the Efficacy of Octreotide Long-acting Release to Decrease Transfusion Requirements and Endoscopy Frequency in Patients With Rendu-Osler-Weber and Gastrointestinal Bleeding

The purpose of this study is to determine whether long-acting octreotide is safe and effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).
The study hypothesis is that octreotide is safe and will reduce transfusion requirements and endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal telangiectasias.

开始日期2016-10-01

申办/合作机构

Radboud University Medical Center

[+1]

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项与 Octreotide depot (GP Pharm SA) 相关的文献（医药）

2025-10-30·EUROPEAN JOURNAL OF ENDOCRINOLOGY

Medical treatment in acromegaly: a network meta-analysis

Review

作者: Haidich, Anna-Bettina ; Ilie, Mirela-Diana ; Anagnostis, Panagiotis ; Raverot, Gérald ; Dekkers, Olaf M ; Kaparounaki, Chrysi ; De Alcubierre, Dario ; Goulis, Dimitrios G ; Isidori, Andrea M

Abstract:

Objective:

Acromegaly is a rare disorder caused by a growth hormone-secreting pituitary adenoma. Clinical trial evidence for its management is limited. This study compared medical treatments for acromegaly through a network meta-analysis, assessing biochemical and radiological responses.

Design:

A systematic review and network meta-analysis were conducted following the preferred reporting items for systematic reviews and network meta-analyses guidelines and Cochrane Handbook recommendations (PROSPERO registration: CRD42023364373).

Methods:

PubMed, Scopus, and Web of Science were searched up to June 2024. Included studies were randomized controlled trials and nonrandomized studies evaluating the efficacy or safety of acromegaly treatments. Primary outcomes were the percentage of adjusted insulin-like growth factor 1 (IGF-1) normalization and tumor shrinkage.

Results:

Twenty-seven studies, involving 4131 patients and 11 treatments were included. Pegvisomant was the best treatment for IGF-1 normalization, followed by pasireotide LAR. Both outperformed first-generation somatostatin receptor ligands (SRLs) combined with dopamine agonists (odds ratio [OR], 1.83; 95% CIs, 1.37-2.46 and OR, 1.46; 95% CIs, 1.02-2.08, respectively; I2 = 41%). Octreotide LAR was superior to oral octreotide capsules (OR, 5.41; 95% CIs, 1.89-15.52). For tumor shrinkage, pasireotide LAR was more effective than SRLs (n = 1059; OR, 11.47; 95% CIs, 1.5-87.64; I2 = 0%). Methodological heterogeneity may have affected comparability.

Conclusions:

Our findings suggest pasireotide LAR and pegvisomant as the most effective treatments for IGF-1 normalization. Pasireotide LAR was the best treatment for tumor shrinkage, though the evidence base was limited, requiring cautious interpretation. Their potential role as first-line options after surgery requires further research. Clinical decisions should consider cost, safety, and patient-specific parameters to optimize outcomes.

2025-10-27·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Surgical treatment and somatostatin experience in growth hormone-secreting pituitary macroadenoma due to novel AIP mutation

Article

作者: Bala, Keziban Aslı ; Eken, Emine Şeyma ; Kurnaz, Erdal ; Yılmaz, Şükriye ; Savaş Erdeve, Şenay ; Karacan Küçükali, Gülin ; Sezer, Abdullah ; Yeşil, Şule ; Keskin, Melikşah ; Karagöz, Kıymet ; Emrahoğlu, Muhammed Erkan ; Düzcan Kilimci, Duygu

Abstract:

Objectives:

Somatotropinomas are extremely rare in children and frequently associated with genetic causes. Among pituitary gigantism, approximately 30 % are attributed to the aryl hydrocarbon receptor-interacting protein ( AIP ) gene mutations, whereas other genetic causes are less common. These mutations cause more aggressive tumors that are challenging to control with a single intervention and often exhibit resistance to somatostatin analogs (SSAs). Our aim is to present a pediatric patient with a somatotropinoma due to a novel AIP variant who responded positively to SSA therapy following a single surgical intervention.

Case presentation:

A 15-year and 8-month-old male patient presented with complaints of excessive height and enlargement of the hands and feet over the past 2 years. Laboratory investigations revealed a random growth hormone level of 50 μg/L (normal range [NR]: 0.077–10.8) and insulin-like growth factor-1(IGF-1) level of 1,107 ng/mL (age-adjusted NR: 224–978/>+2 standardised deviation scores). Magnetic resonance imaging demonstrated a pituitary macroadenoma extending into the suprasellar region. A craniotomy was performed, and the majority of the tumor was resected. Due to the presence of residual tumor, SSA therapy (octreotide-LAR) was initiated. After 1 year of follow-up, IGF-1 levels returned to the normal range, and tumor growth was controlled. Genetic analysis identified a heterozygous frameshift novel variant (c.25delC, p.(Arg9Glyfs*9)) in the AIP gene.

Conclusions:

Although AIP mutation-positive cases are typically resistant to SSAs, our patient carrying a novel AIP variant demonstrated a favorable response to SSA treatment.

2025-08-01·EXPERIMENTAL AND CLINICAL ENDOCRINOLOGY & DIABETES

Experience with the Mixed Meal Test in Diagnosing GIP-Dependent Cortisol Hypersecretion at a Tertiary Center

Article

作者: Akturk, Mujde ; Altinova, Alev Eroglu ; Barlas, Tugba ; Sozen, Sinan ; Karakoç, Ayhan ; Poyraz, Aylar ; Yalcin, Mehmet Muhittin ; Cerit, Ethem Turgay ; Kayhan, Gulsum ; Toruner, Fusun Balos

Abstract:

Aberrant expression of glucose-dependent insulinotropic peptide receptors (GIPR) might regulate increased steroidogenesis in patients with ACTH-independent cortisol hypersecretion. This study investigated the presence of aberrant GIPR expression in patients with ACTH-independent cortisol hypersecretion and bilateral adrenal adenomas.Patients with bilateral adrenal adenomas, ACTH-independent CS and aberrant GIPR screened via mixed meal test were included. Patients’ demographic features and laboratory and imaging findings were obtained retrospectively.Twenty-one patients were included. Overt CS findings were present in 14.3% of the patients. One patient (4.7%) had a complete positive response (537% increase) and one patient (4.7%) had a partial response (41% increase) to the mixed meal test. In the remaining 19 patients, a mean change of -10.1% (range: −56.5% to+24.7%) in cortisol levels was observed at 120 min compared to baseline. The patient with a complete positive response was confirmed using 100 µg of IV octreotide. The patient underwent unilateral adrenalectomy after an inadequate long-term response to octreotide LAR therapy. The histopathology revealed bilateral macronodular adrenal cortical disease. We identified a germline heterozygous frameshift variant in the KDM1A gene in the patient’s blood sample and a recurrent deletion of the p arm of chromosome 1 harboring the KDM1A locus in the adrenal sample.These results may provide useful insights into the screening of aberrant GIPR expression in patients with ACTH-independent hypercortisolism. It is essential to further investigate which patients require screening. Moreover, a significant cortisol peak observed during the mixed meal test in the presence of these receptors has drawn attention.

项与 Octreotide depot (GP Pharm SA) 相关的新闻（医药）

2025-11-27

·和黄医药官微

和黄医药将于2025年欧洲肿瘤内科学会 (ESMO) 亚洲年会和2025年美国血液学会 (ASH) 年会公布临床数据

中国香港、上海和美国新泽西州: 2025年11月27日，星期四: 和黄医药 (中国) 有限公司 (简称 "和黄医药" 或 "HUTCHMED") (纳斯达克/伦敦证交所: HCM; 香港交易所: 13) 今日宣布和黄医药自主研发的化合物的数项研究的最新及更新后的数据将于2025年12月5日至7日在新加坡召开的欧洲肿瘤内科学会 (ESMO) 亚洲年会，以及2025年12月6日至9日在美国奥兰多召开的美国血液学会 (ASH) 年会上公布。抗CD47单克隆抗体HMPL-A83用于治疗晚期实体瘤的首个人体临床试验结果，以及呋喹替尼联合信迪利单抗用于二线治疗局部晚期或转移性肾细胞癌的FRUSICA-2注册研究中II期部分的结果将于2025年ESMO亚洲年会公布。此外，索凡替尼联合卡瑞利珠单抗和化疗用于一线治疗转移性胰腺癌的II/III期研究中II期部分的结果亦将于大会公布。报告详情如下： 2025年ESMO亚洲年会 - 公司申办的研究标题: 抗CD47单克隆抗体HMPL-A83用于治疗晚期实体瘤患者的一项首次人体剂量递增研究 A first-in-human , dose escalation study of HMPL-A83, an anti-CD47 monoclonal antibody in patients with advanced solid tumors 主要作者: 郭晔 (中国上海) 会议环节: 迷你口头报告 | Mini Oral Session: Developmental therapeutics and precision medicine 摘要编号: 162MO 地点: Hall 407 时间: 2025年12月7日 (星期日) 新加坡时间 11:40 – 11:45 标题: 呋喹替尼单药用于二线治疗局部晚期或转移性肾细胞癌: FRUSICA-2研究中II期部分的结果 Fruquintinib monotherapy as second-line treatment in locally advanced or metastatic renal cell carcinoma: results from phase 2 part of FRUSICA-2 主要作者: 王珊珊 (中国上海) 会议环节: 优选口头报告| Proffered Paper session: Genitourinary tumours 摘要编号: 540O 地点: Hall 402 时间: 2025年12月5日 (星期五) 新加坡时间 14:55 – 15:05 标题: 索凡替尼联合卡瑞利珠单抗、白蛋白结合型紫杉醇和吉西他滨用于一线治疗转移性胰腺癌: 一项随机、开放标签、活性对照的II/III期研究的II期部分结果 Surufatinib in combination with camrelizumab, nab-paclitaxel and gemcitabine as the first-line treatment in metastatic pancreatic cancer: results from phase 2 part of a randomized, open-label, active-controlled, phase 2/3 study 主要作者: 秦叔逵 (中国南京) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, non‑colorectal 摘要编号: 375P 标题: 奥希替尼联合赛沃替尼用于治疗EGFR突变伴MET过表达和/或奥希替尼治疗后进展的晚期非小细胞肺癌: SAVANNAH研究的亚洲亚组 Osimertinib + savolitinib in EGFR-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following progressive disease on osi: SAVANNAH Asian subset 主要作者: Se-Hoon Lee (韩国首尔) 会议环节: 海报展示 | Poster Display: Thoracic tumours, metastatic 摘要编号: 982P 标题: SACHI研究的患者相关结局: 一项赛沃替尼联合奥希替尼对比化疗用于治疗EGFR-TKI治疗后疾病进展的EGFR突变伴MET扩增的晚期非小细胞肺癌的III期研究 Patient-relevant Outcomes from SACHI: a Phase 3 Trial of Savolitinib plus Osimertinib versus Chemotherapy in EGFR-mutant and MET-amplified Advanced NSCLC after Progression on EGFR-TKIs 主要作者: 虞永峰 (中国上海) 会议环节: 海报展示 | Poster Display: Thoracic tumours, metastatic 摘要编号: 984P 标题: SACHI研究中FISH和NGS方法检测的MET扩增分析 Analysis of MET Amplification with FISH and NGS Method in SACHI Trial 主要作者: 孙龙华 (中国南昌) 会议环节: 海报展示 | Poster Display: Thoracic tumours, metastatic 摘要编号: 988P 标题: 接受赛沃替尼联合奥希替尼治疗的EGFR突变伴MET扩增的晚期非小细胞肺癌患者的疾病进展模式 Progression pattern in patients with EGFR-mutant , MET-amplified advanced NSCLC treated with savolitinib plus osimertinib 主要作者: 杨海燕 (中国长沙) 会议环节: 海报展示 | Poster Display: Thoracic tumours, metastatic 摘要编号: 1002P 标题: 一线奥希替尼治疗后疾病进展且伴获得性MET过表达和/或扩增的EGFR突变晚期非小细胞肺癌患者的MET检测和治疗顺序: 一项全球真实世界研究的中期分析 MET testing and treatment sequencing after progression on first line osimertinib in patients with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification: interim analysis of a global real world study 主要作者: Julia Rotow (美国波士顿) 会议环节: 海报展示 | Poster Display: Thoracic tumours, metastatic 摘要编号: 1005P 2025年ESMO亚洲年会 - 研究者发起的研究标题: 呋喹替尼联合TAS-102 (联合或不联合立体定向放射治疗) 用于三线或后线治疗转移性结直肠癌:一项前瞻性II期研究的初步结果 Fruquintinib Combined with TAS-102 with or without SBRT as Third- or Later-Line Treatment in Metastatic Colorectal Cancer: Preliminary Results from a Prospective Phase II Trial 主要作者: 张琛 / 王奕 (中国宁波) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, colorectal 摘要编号: 205P 标题: 呋喹替尼联合PD-1抑制剂和西达本胺治疗微卫星稳定型 (MSS) 转移性结直肠癌的疗效和安全性:与真实世界贝伐珠单抗联合抗PD-1抗体和西达本胺组的比较 Efficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide arm 主要作者: 戴广海 / 苟苗苗 (中国北京) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, colorectal 摘要编号: 245eP 标题: 呋喹替尼联合FOLFIRI方案用于二线治疗既往接受过贝伐珠单抗治疗的RAS突变的转移性结直肠癌的疗效和安全性 The Efficacy and Safety of Fruquintinib Plus FOLFIRI as Second-line Treatment in Bevacizumab -pretreated RAS-mutated Metastatic Colorectal Cancer 主要作者: 刘振洋 / 杨晓琳 (中国长沙) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, colorectal 摘要编号: 250eP 标题: 一项评估呋喹替尼联合伊立替康和卡培他滨用于二线治疗晚期结直肠癌患者疗效的真实世界观察性研究 Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer 主要作者: 曲秀娟 / 徐玲 (中国沈阳) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, colorectal 摘要编号: 255eP 标题: 匹配调整后的间接比较索凡替尼与高剂量长效奥曲肽用于治疗晚期非胰腺神经内分泌瘤的疗效 Matching-Adjusted Indirect Comparison of Surufatinib versus High-Dose Octreotide LAR in Advanced Extrapancreatic Neuroendocrine Tumors 主要作者: 徐建明 (中国北京) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, colorectal 摘要编号: 214P 标题: 索凡替尼联合CAPTEM作为不可切除胰腺神经内分泌瘤患者的转化治疗的疗效和安全性: 一项前瞻性、开放标签研究的数据更新 Efficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open-label study 主要作者: 刘续宝 / 王孜尧 (中国成都) 会议环节: 海报展示 | Poster Display: Gastrointestinal tumours, colorectal 摘要编号: 400P 索乐匹尼布用于治疗慢性原发免疫性血小板减少症成人患者的ESLIM-01中国III期研究的长期结果将于2025年ASH年会上公布。报告详情如下： 2025年ASH年会 - 公司申办的研究标题: ESLIM-01 III期研究: 索乐匹尼布长期治疗慢性原发免疫性血小板减少症成人患者的疗效和安全性最终分析 Phase 3 ESLIM-01 study: Final analysis of efficacy and safety of long-term treatment with sovleplenib in adults with chronic primary immune thrombocytopenia 主要作者: 杨仁池 (中国天津) 会议环节: 口头报告 | Oral Abstract Session 摘要编号: 843 地点: Room OCCC - W304EFGH 时间: 2025年12月8日 (星期一) 美国东部时间 15:15 –15:30 关于呋喹替尼呋喹替尼是一种针对所有三种血管内皮生长因子受体 ("VEGFR")-1、-2和-3的选择性口服抑制剂。VEGFR抑制剂在抑制肿瘤的血管生成中起到至关重要的作用。在中国，呋喹替尼由和黄医药及礼来公司合作研发和商业化，并以商品名爱优特®上市。武田拥有在中国内地、香港和澳门以外进一步开发、商业化和生产呋喹替尼的全球独家许可，并以商品名FRUZAQLA®上市销售。关于HMPL-A83 HMPL-A83是一种研究性IgG4型人源化抗CD47单克隆抗体，能够与CD47高亲和力结合。HMPL-A83能够阻断CD47与信号调节蛋白 (SIRP) α的结合，并干扰癌细胞用来保护其免受免疫系统攻击的"别吃我"信号。和黄医药目前拥有HMPL-A83在全球范围内的所有权利。关于赛沃替尼赛沃替尼是一种强效、高选择性的口服MET酪氨酸激酶抑制剂，在晚期实体瘤中表现出临床活性。赛沃替尼可阻断因突变 (例如外显子14跳跃突变或其他点突变)、基因扩增或蛋白质过表达而导致的MET受体酪氨酸激酶信号通路的异常激活。赛沃替尼由阿斯利康与和黄医药共同开发，并以商品名沃瑞沙®由阿斯利康商业化。关于索凡替尼索凡替尼是一种新型的口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。索凡替尼可通过抑制VEGFR和成纤维细胞生长因子受体 (FGFR) 以阻断肿瘤血管生成，并可抑制集落刺激因子-1受体 (CSF-1R)，通过调节肿瘤相关巨噬细胞，促进机体对肿瘤细胞的免疫应答。索凡替尼在中国市场由和黄医药以商品名苏泰达®上市销售。和黄医药目前拥有索凡替尼在全球范围内的所有权利。关于索乐匹尼布索乐匹尼布是一种探索性的新型、选择性的口服小分子脾酪氨酸激酶 ("Syk") 抑制剂。Syk作为B细胞受体和Fc受体信号传导通路中的一个关键蛋白，是多种亚型的B细胞淋巴瘤及自身免疫疾病的成熟治疗靶点。和黄医药目前保留索乐匹尼布在全球的所有权利。前瞻性陈述本新闻稿包含1995年《美国私人证券诉讼改革法案》"安全港" 条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对呋喹替尼、HMPL-A83、索凡替尼、赛沃替尼和索乐匹尼布的治疗潜力的预期，呋喹替尼、HMPL-A83、索凡替尼、赛沃替尼和索乐匹尼布的进一步临床研究计划，对呋喹替尼、HMPL-A83、索凡替尼、赛沃替尼和索乐匹尼布的研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性；临床方案或监管要求变更；非预期不良事件或安全性问题；呋喹替尼、HMPL-A83、索凡替尼、赛沃替尼和索乐匹尼布 (包括作为联合疗法) 达到研究的主要或次要终点的疗效；获得不同司法管辖区的监管批准及获得监管批准后获得上市许可；呋喹替尼、HMPL-A83、索凡替尼、赛沃替尼和索乐匹尼布用于目标适应症的潜在市场，以及资金充足性等。此外，由于部分研究可能依赖于与其他药物 (例如卡瑞利珠单抗和奥希替尼) 联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问：www.hutch-med.com/sc。

临床2期临床结果

2025-11-27

·GlobeNewswire-Health Care

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress and the 2025 ASH Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 27, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Asia Congress 2025, taking place on December 5-7, 2025 in Singapore, and the American Society of Hematology (“ASH”) Annual Meeting taking place on December 6-9, 2025 in Orlando, USA. Results from a first-in-human study of the anti-CD47 monoclonal antibody HMPL-A83 in advanced solid tumors, as well as from the phase II part of the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma, will be presented at the ESMO Asia Congress 2025. Results from the phase II part of the phase II/III study of surufatinib in combination with camrelizumab and chemotherapy as a first-line treatment for metastatic pancreatic cancer will also be reported. Details of the presentations are as follows: Abstract titlePresenter/Lead authorPresentation detailsESMO Asia Congress 2025 - SPONSORED STUDIES A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti-CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumorsYe Guo (Shanghai, China)162MO | Mini Oral session: Developmental therapeutics and precision medicineSunday, December 7, 202511:40 - 11:45 SGTHall 407Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2Shanshan Wang (Shanghai, China)540O | Proffered Paper session: Genitourinary tumoursFriday, December 5, 202514:55 - 15:05 SGT Hall 402Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: results from phase 2 part of a randomized, open-label, active-controlled, phase 2/3 studyShukui Qin (Nanjing, China)375P | Poster Display: Gastrointestinal tumours, non‑colorectalOsimertinib (osi) + savolitinib (savo) in EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) with MET overexpression and/or amplification (OverExp/Amp) following progressive disease (PD) on osi: SAVANNAH Asian subsetSe-Hoon Lee (Seoul, Korea)982P | Poster Display: Thoracic tumours, metastaticPatient-relevant Outcomes (PROs) from SACHI: a Phase 3 Trial of Savolitinib (Savo) plus Osimertinib (Osi) versus Chemotherapy (Chemo) in EGFR-mutant (EGFRm) and MET-amplified (METamp) Advanced NSCLC after Progression on EGFR-TKIsYongfeng Yu (Shanghai, China)984P | Poster Display: Thoracic tumours, metastaticAnalysis of MET Amplification (METamp) with FISH and NGS Method in SACHI TrialLonghua Sun (Nanchang, China)988P | Poster Display: Thoracic tumours, metastaticProgression pattern in patients (pts) with EGFR-mutant (EGFRm), MET-amplified (METamp) advanced NSCLC treated with savolitinib (savo) plus osimertinib (osi)Haiyan Yang (Changsha, China)1002P | Poster Display: Thoracic tumours, metastaticMET testing and treatment (tx) sequencing after progression of disease (PD) on first-line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Final analysis of a global real-world (rw) studyJulia Rotow (Boston, US)1005P | Poster Display: Thoracic tumours, metastatic ESMO Asia Congress 2025 - INVESTIGATOR-INITIATED STUDIES Fruquintinib Combined with TAS-102 with or without SBRT as Third- or Later-Line Treatment in Metastatic Colorectal Cancer: Preliminary Results from a Prospective Phase II TrialChen Zhang/ Yi Wang(Ningbo, China)205P | Poster Display: Gastrointestinal tumours, colorectalEfficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide armGuanghai Dai/ Miaomiao Gou(Beijing, China)245eP | Poster Display: Gastrointestinal tumours, colorectalThe Efficacy and Safety of Fruquintinib (F) Plus FOLFIRI as Second-line (2L) Treatment in Bevacizumab (Bev)-pretreated RAS-mutated (RAS‑m) Metastatic Colorectal Cancer (mCRC)Zhenyang Liu/ Xiaolin Yang(Changsha, China)250eP | Poster Display: Gastrointestinal tumours, colorectalReal-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal CancerXiujuan Qu/ Lin Xu (Shenyang, China)255eP | Poster Display: Gastrointestinal tumours, colorectalMatching-Adjusted Indirect Comparison of Surufatinib versus High-Dose Octreotide LAR in Advanced Extrapancreatic Neuroendocrine TumorsJianming Xu (Beijing, China)214P | Poster Display: Gastrointestinal tumours, colorectalEfficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open-label studyXubao Liu/ Ziyao Wang (Chengdu, China)400P | Poster Display: Gastrointestinal tumours, non‑colorectal Final analysis of long-term results of sovleplenib’s ESLIM-01 China Phase III study in in adult patients with chronic primary immune thrombocytopenia will be presented at the 2025 ASH Annual Meeting. Details of the presentation is as follows: Abstract titlePresenter/Lead authorPresentation details2025 ASH Annual Meeting - SPONSORED STUDIES Phase 3 ESLIM-01 study: Final analysis of efficacy and safety of long-term treatment with sovleplenib in adults with chronic primary immune thrombocytopeniaRenchi Yang (Tianjin, China)843 | Oral Abstract SessionMonday, December 8, 202515:15 - 15:30 EST Room OCCC - W304EFGH About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, ‑2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. About HMPL-A83 HMPL-A83 is an investigational IgG4-type humanized anti-CD47 monoclonal antibody that exhibits high affinity for CD47. HMPL-A83 blocks CD47 binding to Signal regulatory protein (SIRP) α and disrupts the “do not eat me” signal that cancer cells use to shield themselves from the immune system. HUTCHMED currently retains all rights to HMPL-A83 worldwide. About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide. About Sovleplenib Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders. HUTCHMED currently retains all rights to sovleplenib worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, the further clinical development for fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, its expectations as to whether any studies on fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as camrelizumab and osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

临床2期免疫疗法临床结果引进/卖出临床3期

2025-11-26

·香港证券交易所

自願性公告 - 和黃醫藥將於2025年歐洲腫瘤內科學會 (ESMO) 亞洲年會和2025年美國血液學會 (ASH) 年會公佈臨床數據

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 HUTCHMED (China) Limited 和黃醫藥（中國）有限公司（於開曼群島註冊成立的有限公司）（股份代號：13）自願性公告和黃醫藥將於2025年歐洲腫瘤內科學會 (ESMO) 亞洲年會和 2025年美國血液學會 (ASH) 年會公佈臨床數據和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或「HUTCHMED」）今日宣佈和黃醫藥自主研發的化合物的數項研究的最新及更新後的數據將於2025年12月5日至7日在新加坡召開的歐洲腫瘤內科學會（ESMO）亞洲年會，以及 2025年12月6日至9日在美國奧蘭多召開的美國血液學會（ASH）年會上公佈。抗CD47單克隆抗體HMPL-A83用於治療晚期實體瘤的首個人體臨床試驗結果，以及呋喹替尼（fruquintinib）聯合信迪利單抗（sintilimab）用於二線治療局部晚期或轉移性腎細胞癌的FRUSICA-2註冊研究中II期部分的結果將於 2025年ESMO亞洲年會公佈。此外，索凡替尼（surufatinib）聯合卡瑞利珠單抗（camrelizumab）和化療用於一線治療轉移性胰腺癌的II/III期研究中II期部分的結果亦將於大會公佈。報告詳情如下： |2025年ESMO亞洲年會 - 公司申辦的研究|Col2|Col3| |---|---|---| |抗CD47單克隆抗體HMPL-A83用於治療晚期實體瘤患者的一項首次人體劑量遞增研究 A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti- CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumors|郭曄 (中國上海)|162MO 迷你口頭報告| Mini Oral Session: Developmental therapeutics and precision medicine 2025年12月7日 (星期日) 新加坡時間 11:40 ‒ 11:45 Hall 407| |呋喹替尼單藥用於二線治療局部晚期或轉移性腎細胞癌: FRUSICA-2研究中II期部分的結果 Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2|王珊珊 (中國上海)|540O 優選口頭報告| Proffered Paper session: Genitourinary tumours 2025年12月5日 (星期五) 新加坡時間 14:55 ‒ 15:05 Hall 402| |索凡替尼聯合卡瑞利珠單抗、白蛋白結合型紫杉醇和吉西他濱用於一線治療轉移性胰腺癌: 一項隨機、開放標簽、活性對照的II/III期研究的II期部分結果 Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: results from phase 2 part of a randomized, open-label, active-controlled, phase 2/3 study|秦叔逵 (中國南京)|375P 海報展示 | Poster Display: Gastrointestinal tumours, non-colorectal| |摘要標題|報告人/ 主要作者|報告詳情| |---|---|---| |奧希替尼聯合賽沃替尼用於治療EGFR突變伴MET過表達和/或奧希替尼治療後進展的晚期非小細胞肺癌: SAVANNAH研究的亞洲亞組 Osimertinib (osi) + savolitinib (savo) in EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) with MET overexpression and/or amplification (OverExp/Amp) following progressive disease (PD) on osi: SAVANNAH Asian subset|Se-Hoon Lee (韓國首爾)|982P 海報展示 | Poster Display: Thoracic tumours, metastatic| |SACHI研究的患者相關結局: 一項賽沃替尼聯合奧希替尼對比化療用於治療EGFR- TKI治療後疾病進展的EGFR突變伴MET擴增的晚期非小細胞肺癌的III期研究 Patient-relevant Outcomes (PROs) from SACHI: a Phase 3 Trial of Savolitinib (Savo) plus Osimertinib (Osi) versus Chemotherapy (Chemo) in EGFR- mutant (EGFRm) and MET-amplified (METamp) Advanced NSCLC after Progression on EGFR-TKIs|虞永峰 (中國上海)|984P 海報展示 | Poster Display: Thoracic tumours, metastatic| |SACHI研究中FISH和NGS方法檢測的MET擴增分析 Analysis of MET Amplification (METamp) with FISH and NGS Method in SACHI Trial|孫龍華 (中國南昌)|988P 海報展示 | Poster Display: Thoracic tumours, metastatic| |接受賽沃替尼聯合奧希替尼治療的EGFR突變伴MET擴增的晚期非小細胞肺癌患者的疾病進展模式 Progression pattern in patients (pts) with EGFR-mutant (EGFRm), MET- amplified (METamp) advanced NSCLC treated with savolitinib (savo) plus osimertinib (osi)|楊海燕 (中國長沙)|1002P 海報展示 | Poster Display: Thoracic tumours, metastatic| |一線奧希替尼治療後疾病進展的EGFR突變晚期非小細胞肺癌患者MET檢測和治療的順序以及獲得性MET過表達和/或擴增: 一項全球真實世界研究的最終分析 MET testing and treatment (tx) sequencing after progression of disease (PD) on first-line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Final analysis of a global real-world (rw) study|Julia Rotow (美國波士頓)|1005P 海報展示 | Poster Display: Thoracic tumours, metastatic| |2025年ESMO亞洲年會 - 研究者發起的研究|Col2|Col3| |---|---|---| |呋喹替尼聯合TAS-102 (聯合或不聯合立體定向放射治療) 用於三線或後線治療轉移性結直腸癌: 一項前瞻性II期研究的初步結果 Fruquintinib Combined with TAS-102 with or without SBRT as Third- or Later-Line Treatment in Metastatic Colorectal Cancer: Preliminary Results from a Prospective Phase II Trial|張琛 / 王奕 (中國寧波)|205P 海報展示 | Poster Display: Gastrointestinal tumours, colorectal| |呋喹替尼聯合PD-1抑制劑和西達本胺治療微衛星穩定型 (MSS) 轉移性結直腸癌的療效和安全性: 與真實世界貝伐珠單抗聯合抗PD-1抗體和西達本胺組的比較 Efficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide arm|戴廣海 / 苟苗苗 (中國北京)|245eP 海報展示 | Poster Display: Gastrointestinal tumours, colorectal| |呋喹替尼聯合FOLFIRI方案用於二線治療既往接受過貝伐珠單抗治療的RAS突變的轉移性結直腸癌的療效和安全性 The Efficacy and Safety of Fruquintinib (F) Plus FOLFIRI as Second-line (2L) Treatment in Bevacizumab (Bev)-pretreated RAS-mutated (RAS-m) Metastatic Colorectal Cancer (mCRC)|劉振洋 / 楊曉琳 (中國長沙)|250eP 海報展示 | Poster Display: Gastrointestinal tumours, colorectal| |一項評估呋喹替尼聯合伊立替康和卡培他濱用於二線治療晚期結直腸癌患者療效的真實世界觀察性研究 Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer|曲秀娟 / 徐玲 (中國沈陽)|255eP 海報展示 | Poster Display: Gastrointestinal tumours, colorectal| |匹配調整後的間接比較索凡替尼與高劑量長效奧曲肽用於治療晚期非胰腺神經內分泌瘤的療效 Matching-Adjusted Indirect Comparison of Surufatinib versus High-Dose Octreotide LAR in Advanced Extrapancreatic Neuroendocrine Tumors|徐建明 (中國北京)|214P 海報展示 | Poster Display: Gastrointestinal tumours, colorectal| |摘要標題|報告人/ 主要作者|報告詳情| |---|---|---| |索凡替尼聯合CAPTEM作為不可切除胰腺神經內分泌瘤患者的轉化治療的療效和安全性: 一項前瞻性、開放標簽研究的數據更新 Efficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open- label study|劉續寶 / 王孜堯 (中國成都)|400P 海報展示 | Poster Display: Gastrointestinal tumours, non-colorectal| 索樂匹尼布（sovleplenib）用於治療慢性原發免疫性血小板減少症成人患者的ESLIM-01中國III期研究的長期結果將於2025年ASH年會上公佈。報告詳情如下：關於呋喹替尼呋喹替尼是一種針對所有三種血管內皮生長因子受體（「VEGFR」）-1 、-2和-3的選擇性口服抑制劑。 VEGFR抑制劑在抑制腫瘤的血管生成中起到至關重要的作用。在中國，呋喹替尼由和黃醫藥及禮來公司合作研發和商業化，並以商品名愛優特® （ELUNATE®）上市。武田擁有在中國內地、香港和澳門以外進一步開發、商業化和生產呋喹替尼的全球獨家許可，並以商品名FRUZAQLA®上市銷售。關於HMPL-A83 HMPL-A83是一種研究性IgG4型人源化抗CD47單克隆抗體，能夠與CD47高親和力結合。HMPL-A83能夠阻斷CD47 與信號調節蛋白（SIRP）α的結合，並干擾癌細胞用來保護其免受免疫系統攻擊的「別吃我」信號。和黃醫藥目前擁有HMPL-A83在全球範圍內的所有權利。關於賽沃替尼賽沃替尼是一種強效、高選擇性的口服MET酪氨酸激酶抑制劑，在晚期實體瘤中表現出臨床活性。賽沃替尼可阻斷因突變（例如外顯子14跳躍突變或其他點突變）、基因擴增或蛋白質過表達而導致的MET受體酪氨酸激酶信號通路的異常激活。賽沃替尼由阿斯利康與和黃醫藥共同開發，並以商品名沃瑞沙® （ORPATHYS®）由阿斯利康商業化。關於索凡替尼索凡替尼是一種新型的口服酪氨酸激酶抑制劑，具有抗血管生成和免疫調節雙重活性。索凡替尼可通過抑制VEGFR 和成纖維細胞生長因子受體（FGFR）以阻斷腫瘤血管生成，並可抑制集落刺激因子-1受體（CSF-1R），通過調節腫瘤相關巨噬細胞，促進機體對腫瘤細胞的免疫應答。索凡替尼在中國市場由和黃醫藥以商品名蘇泰達® （SULANDA®）上市銷售。和黃醫藥目前擁有索凡替尼在全球範圍內的所有權利。關於索樂匹尼布索樂匹尼布是一種探索性的新型、選擇性的口服小分子脾酪氨酸激酶（「Syk」）抑製劑。Syk作為B細胞受體和Fc受體信號傳導通路中的一個關鍵蛋白，是多種亞型的B細胞淋巴瘤及自身免疫疾病的成熟治療靶點。和黃醫藥目前保留索樂匹尼布在全球的所有權利。關於和黃醫藥和黃醫藥（納斯達克/倫敦證交所：HCM ；香港交易所：13）是一家處於商業化階段的創新型生物醫藥公司，致力於發現、全球開發和商業化治療癌症和免疫性疾病的靶向藥物和免疫療法。自成立以來，和黃醫藥致力於將自主發現的候選藥物帶向全球患者，首三個藥物現已在中國上市，其中首個藥物亦於美國、歐洲和日本等全球各地獲批。欲了解更多詳情，請訪問：www.hutch-med.com或關注我們的LinkedIn專頁。前瞻性陳述本公告包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對呋喹替尼、HMPL-A83 、索凡替尼、賽沃替尼和索樂匹尼布的治療潛力的預期，呋喹替尼、HMPL-A83 、索凡替尼、賽沃替尼和索樂匹尼布的進一步臨床研究計劃，對呋喹替尼、HMPL-A83、索凡替尼、賽沃替尼和索樂匹尼布的研究是否能達到其主要或次要終點的預期，以及對此類研究完成時間和結果發佈的預期。此類風險和不確定性包括下列假設：入組率、滿足研究入選和排除標準的受試者的時間和可用性；臨床方案或監管要求變更；非預期不良事件或安全性問題；呋喹替尼、HMPL-A83、索凡替尼、賽沃替尼和索樂匹尼布（包括作為聯合療法）達到研究的主要或次要終點的療效；獲得不同司法管轄區的監管批准及獲得監管批准後獲得上市許可；呋喹替尼、HMPL-A83、索凡替尼、賽沃替尼和索樂匹尼布用於目標適應症的潛在市場，以及資金充足性等。此外，由於部分研究可能依賴於與其他藥物（例如卡瑞利珠單抗和奧希替尼）聯合使用，因此此類風險和不確定性包括有關這些治療藥物的安全性、療效、供應和監管批准的假設。當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本公告發佈當日有效。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會、香港聯合交易所有限公司以及AIM提交的文件。無論是否出現新訊息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本公告所含訊息的義務。醫療信息本公告所提到的産品可能並未在所有國家上市，或可能以不同的商標進行銷售，或用於不同的病症，或採用不同的劑量，或擁有不同的效力。本文中所包含的任何信息都不應被看作是任何處方藥的申請、推廣或廣告，包括那些正在研發的藥物。於本公告日期，本公司之董事為：主席兼非執行董事：艾樂德博士蘇慰國博士（首席執行官兼首席科學官）鄭澤鋒先生（代理首席執行官兼首席財務官）非執行董事：施熙德女士楊凌女士莫樹錦教授（高級兼首席獨立非執行董事）言思雅醫生胡朝紅博士陳邵文教授黃德偉先生

临床2期临床成功临床结果

100 项与 Octreotide depot (GP Pharm SA) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB00104

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适应症	国家/地区	公司	日期
肢端肥大症	西班牙	GP Pharm SA	-
食道静脉出血	西班牙	GP Pharm SA	-

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适应症	最高研发状态	国家/地区	公司	日期
肠梗阻	临床2期	法国	Novartis Pharmaceuticals Corp.	2005-09-01
腹膜癌	临床2期	法国	Novartis Pharmaceuticals Corp.	2005-09-01
晚期前列腺癌	临床2期	意大利	Novartis AG	2004-02-01

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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


ASCO_GI2025	N/A	胃神经内分泌肿瘤辅助 ki67	35	Somatostatin analogs (long-acting releasing octreotide 30 mg)	鬱餘繭憲廠餘糧夢網餘(蓋鏇壓膚鬱鑰願鏇製鹹) = 艱觸觸窪網鹹鑰餘蓋積餘遞衊糧構獵糧齋憲構 (廠顧淵鬱廠夢選願餘鬱, 67 ~ NR)	积极	2025-01-23
				Lanreotide 120 mg	鬱餘繭憲廠餘糧夢網餘(蓋鏇壓膚鬱鑰願鏇製鹹) = 鏇膚積襯獵簾膚網齋觸餘遞衊糧構獵糧齋憲構 (廠顧淵鬱廠夢選願餘鬱, 67 ~ NR)
NCT01538966 (CTgov)	N/A	肢端肥大症	76	Octreotide LAR+Lanreotide+Pegvisomant (High Dose SRL + Weekly Pegvisomant)	衊窪淵獵願廠製鬱網繭(衊衊餘製艱窪顧窪憲壓) = 夢鬱積範膚鑰鏇餘構淵鑰築窪積觸餘網憲襯夢 (顧製夢蓋築願壓築壓鹹, 1,645.49) 更多	-	2023-01-04
				Octreotide LAR+Lanreotide+Pegvisomant (Low Dose SRL + Daily Pegvisomant)	衊窪淵獵願廠製鬱網繭(衊衊餘製艱窪顧窪憲壓) = 積膚範鑰鹽壓醖獵蓋繭鑰築窪積觸餘網憲襯夢 (顧製夢蓋築願壓築壓鹹, 11,158.49) 更多
ASCO_GI2018	N/A	胃肠胰神经内分泌肿瘤一线 \| 二线	273	Octreotide	壓簾膚選顧獵顧簾鏇鑰(窪鬱積鹽憲遞襯鹽獵遞) = 憲範糧艱糧鬱鏇鬱鑰網積膚夢範蓋憲繭鹹夢獵 (糧醖壓襯製積選壓鑰鬱, 51%)	-	2018-02-26
Pubmed \| PLoS One	临床2期	胸腺肿瘤新辅助 positive octreotide scans	17	Octreotide LAR	廠鬱齋鬱艱築鹹鹽網願(簾觸積膚廠廠鬱積鑰齋) = 71% 範膚壓糧醖觸衊糧鹽夢 (願鏇築襯鏇築壓鹹衊壓 ) 更多	积极	2016-12-16
NCT01371643 (CTgov)	临床4期	垂体腺瘤 \| 肢端肥大症	41	Octreotide LAR (Medical Treatment by Octreotide LAR)	構憲艱衊網觸繭餘選糧 = 築憲鑰夢艱簾遞遞獵積構糧廠夢構廠鑰簾遞艱 (淵鹽願選壓糧膚壓鏇艱, 醖選艱憲餘選糧選鹹簾 ~ 製夢積鹹淵積膚鹹糧獵) 更多	-	2016-07-22
				transsphenoidal surgery+Octreotide LAR (Surgical Debulking Followed by Octreotide LAR)	構憲艱衊網觸繭餘選糧 = 窪廠齋衊網構鏇鏇積選構糧廠夢構廠鑰簾遞艱 (淵鹽願選壓糧膚壓鏇艱, 醖夢網醖糧選淵鏇鹽築 ~ 艱蓋簾顧構憲壓網鏇製) 更多
ASCO2015	N/A	神经内分泌肿瘤	-	Octreotide LAR	餘選壓衊顧壓襯襯醖繭(膚鬱醖積製鏇壓廠簾範) = 願廠遞壓網鏇糧壓繭襯夢簾鹽衊築鹹積鹽憲膚 (憲繭積窪鹽構艱憲鹹夢 ) 更多	-	2015-05-20
ASCO_GI2015	N/A	神经内分泌肿瘤	214	Octreotide LAR (Group A)	願壓顧糧餘憲觸醖齋鹹(築鹽製衊願鬱繭壓鹽鏇) = 積廠鏇鑰衊鑰鑰遞蓋淵壓壓網鏇廠鏇鏇齋壓餘 (鏇憲繭齋夢構遞觸膚糧, 13.2–31.5)	-	2015-01-20
				Octreotide LAR (Group B)	願壓顧糧餘憲觸醖齋鹹(築鹽製衊願鬱繭壓鹽鏇) = 糧鏇鏇鬱簾遞遞膚顧糧壓壓網鏇廠鏇鏇齋壓餘 (鏇憲繭齋夢構遞觸膚糧, 20.5–51.1)
ASCO2014	临床3期	晚期神经内分泌肿瘤	254	Octreotide LAR	窪餘築憲窪壓廠齋淵選(簾選鏇選糧壓構蓋鬱壓) = 選廠築觸夢積積醖窪齋齋鏇築糧願衊醖衊顧艱 (鏇廠糧網壓廠觸鑰鏇顧, 32 ~ 52)	-	2014-05-20
ASCO2014	N/A	神经内分泌肿瘤	-	Octreotide LAR (OCT-L)	夢繭夢網積艱獵觸壓鑰(築繭襯鑰積蓋憲觸鬱選) = 淵憲範蓋醖廠襯簾築繭憲構膚顧繭衊願願網壓 (製積獵選鑰鏇憲積顧製 )	-	2014-05-20
				No OCT-L	夢繭夢網積艱獵觸壓鑰(築繭襯鑰積蓋憲觸鬱選) = 願獵窪鬱製醖餘齋選顧憲構膚顧繭衊願願網壓 (製積獵選鑰鏇憲積顧製 )
NCT00108355 (CTgov)	临床4期	纤维化 \| 腹水	29	Oral tablet (Midodrine placebo)	齋齋觸遞構壓觸獵齋範(獵築獵選選觸艱製襯壓) = 鬱壓鏇鏇簾製夢蓋艱蓋壓艱廠製窪觸鹹齋積蓋 (憲夢蓋憲遞簾網範製鏇, 簾膚餘範簾蓋齋衊艱選 ~ 鹽餘鑰觸齋醖醖築憲鹽) 更多	-	2014-03-06