预约演示
更新于：2026-03-28
Indapamide/Amlodipine Besylate/Telmisartan
氨氯地平/替米沙坦/吲达帕胺
更新于：2026-03-28
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2025-06-05), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C20H25ClN2O5 |
InChIKeyHTIQEAQVCYTUBX-UHFFFAOYSA-N |
CAS号88150-42-9 |
查看全部结构式(3)
关联
7
项与 氨氯地平/替米沙坦/吲达帕胺 相关的临床试验NCT04518293
Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension
Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.
开始日期2021-07-09 |
申办/合作机构 |
NCT04518306
Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension
Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to placebo.
开始日期2021-06-14 |
申办/合作机构 |
SLCTR/2021/007
Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to dual combinations for the treatment of hypertension: An international, multi-center, randomized, double-blind, active-controlled, parallel-group trial.
开始日期2021-03-06 |
申办/合作机构- |
100 项与 氨氯地平/替米沙坦/吲达帕胺 相关的临床结果
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100 项与 氨氯地平/替米沙坦/吲达帕胺 相关的转化医学
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100 项与 氨氯地平/替米沙坦/吲达帕胺 相关的专利（医药）
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6
项与 氨氯地平/替米沙坦/吲达帕胺 相关的文献（医药）2024-12-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension
Article
作者: Salam, Abdul ; Spiering, Wilko ; Ranasinghe, Gotabhaya ; Lakshman, Poopalan ; Schutte, Aletta E ; Wang, Nelson ; Williams, Bryan ; Ojji, Dike B ; Schutte, Aletta E. ; Gutierez, Alexis ; Wright, Jackson T ; de Silva, H Asita ; Narkiewicz, Krzysztof ; Whelton, Paul ; de Silva, H. Asita ; Shanthakumar, Mathangi ; Cushman, William C. ; Liu, Xiaoqiu ; Gianacas, Chris ; Cushman, William C ; Schlaich, Markus P ; Poulter, Neil R ; Di Tanna, Gian Luca ; Wright, Jackson T. ; Ojji, Dike B. ; Sanni, Aliu ; Poulter, Neil R. ; McMullen, Deirdre ; Rodgers, Anthony ; Schlaich, Markus P. ; Oparil, Suzanne ; Grobbee, Diederick
BACKGROUND:
Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension.
OBJECTIVES:
The authors conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety.
METHODS:
This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event.
RESULTS:
From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group.
CONCLUSIONS:
In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).
2024-10-01·LANCET
Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial
Article
作者: Salam, Abdul ; Spiering, Wilko ; Hay, P ; Schutte, Aletta E ; Wang, Nelson ; Uluwattage, W ; Williams, Bryan ; Ojji, Dike B ; Lakshman, P ; Gnanenthiran, Sonali R ; Gianacas, Chris ; de Silva, H Asita ; Wright, Jackson T ; Narkiewicz, Krzysztof ; Liu, Xiaoqiu ; Ranasinghe, G ; Shanthakumar, Mathangi ; Cushman, William C ; Poulter, Neil R ; Schlaich, Markus P ; Di Tanna, Gian Luca ; Pereira, T ; Grobbee, Diederick E ; Amarasena, N ; Rodgers, Anthony ; Oparil, Suzanne ; Whelton, Paul K
BACKGROUND:
Single-pill combinations (SPCs) of three low-dose antihypertensive drugs can improve hypertension control but are not widely available. A key issue for any combination product is the contribution of each component to efficacy and tolerability. This trial compared a new triple SPC called GMRx2, containing telmisartan, amlodipine, and indapamide, with dual combinations of components for efficacy and safety.
METHODS:
In this international, randomised, double-blind, active-controlled trial, we enrolled adults with hypertension receiving between zero and three antihypertensive drugs, with a screening systolic blood pressure (SBP) ranging from 140-179 mm Hg (on no drugs) to 110-150 mm Hg (on three drugs). Participants were recruited from Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK, and the USA. In a 4-week active run-in, existing medications were switched to GMRx2 half dose (telmisartan 20 mg, amlodipine 2·5 mg, and indapamide 1·25 mg). Participants were then randomly allocated (2:1:1:1) to continued GMRx2 half dose or to each possible dual combination of components at half doses (telmisartan 20 mg with amlodipine 2·5 mg, telmisartan 20 mg with indapamide 1·25 mg, or amlodipine 2·5 mg with indapamide 1·25 mg). At week 6, doses were doubled in all groups, unless there was a clinical contraindication. The primary efficacy outcome was mean change in home SBP from baseline to week 12, and the primary safety outcome was withdrawal of treatment due to an adverse event from baseline to week 12. Secondary efficacy outcomes included differences in clinic and home blood pressure levels and control rates. This study is registered with ClinicalTrials.gov, NCT04518293, and is completed.
FINDINGS:
The trial was conducted between July 9, 2021 and Sept 1, 2023. We randomly allocated 1385 participants to four groups: 551 to GMRx2, 276 to telmisartan-indapamide, 282 to telmisartan-amlodipine, and 276 to amlodipine-indapamide groups. The mean age was 59 years (SD 11), 712 (51%) participants self-reported as female and 673 (48·6%) male, and the mean clinic blood pressure at the screening visit was 142/85 mm Hg when taking an average of 1·6 blood pressure medications. Following the run-in on GMRx2 half dose, the mean clinic blood pressure level at randomisation was 133/81 mm Hg and the mean home blood pressure level was 129/78 mm Hg. At week 12, the mean home SBP was 126 mm Hg in the GMRx2 group, which was lower than for each of the dual combinations: -2·5 (95% CI -3·7 to -1·3, p<0·0001) versus telmisartan-indapamide, -5·4 (-6·8 to -4·1, p<0·0001) versus telmisartan-amlodipine, and -4·4 (-5·8 to -3·1, p<0·0001) versus amlodipine-indapamide. For the same comparisons, differences in clinic blood pressure at week 12 were 4·3/3·5 mm Hg, 5·6/3·7 mm Hg, and 6·3/4·5 mm Hg (all p<0·001). Clinic blood pressure control rate below 140/90 mm Hg at week 12 was superior with GMRx2 (74%) to with each dual combination (range 53-61%). Withdrawal of treatment due to adverse events occurred in 11 (2%) participants in the GMRx2 group, four (1%) in telmisartan-indapamide, three (1%) in telmisartan-amlodipine, and four (1%) in amlodipine-indapamide, with none of the differences being statistically significant.
INTERPRETATION:
A novel low-dose SPC product of telmisartan, amlodipine, and indapamide provided clinically meaningful improvements in blood pressure reduction compared with dual combinations and was well tolerated. This SPC provides a new therapeutic option for the management of hypertension and its use could result in a substantial improvement in blood pressure control in clinical practice.
FUNDING:
George Medicines.
2024-02-14·Global heart
Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension
Article
作者: Neil Poulter ; Sonali R. Gnanenthiran ; Paul Whelton ; Bryan Williams ; William Cushman ; Jackson T. Wright ; Dike Ojji ; Markus P. Schlaich ; Asita de Silva ; Gian Luca Di Tanna ; Suzanne Oparil ; Aletta E. Schutte ; Wilko Spiering ; Anthony Rodgers ; Krzysztof Narkiewicz ; Abdul Salam ; Diederick Grobbee
Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these 'hypertension polypills' were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.
28
项与 氨氯地平/替米沙坦/吲达帕胺 相关的新闻（医药）2026-03-16
Arrotex gains exclusive rights in Australia and New Zealand to innovative single pill combination of three hypertension medicines, including two doses that are lower than those currently available in single pill combinations
GMRx2 is designed to deliver blood pressure-lowering benefits of triple combination therapy early in the treatment pathway, with an established safety profile
George Medicines receives upfront licensing fee and is eligible for commercial milestone payments, as well as a future recurring revenue stream through a tiered royalty rate on sales in Australia and New Zealand
Arrotex to seek regulatory approval of GMRx2 in Australia and New Zealand
London, UK, 16 March 2026
– George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, has entered into an exclusive licensing and supply agreement with Arrotex Pharmaceuticals (“Arrotex”), a leading Australian pharmaceutical company and Australia’s largest supplier of medicines by prescription volume, granting Arrotex exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Australia.
GMRx2 is an innovative single pill combination of three medicines, telmisartan, amlodipine and indapamide, for the treatment of hypertension, developed in three doses, including two doses that are lower than those currently available in single pill combinations. By leveraging a multi-mechanism approach and lower doses, GMRx2 is formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the known safety profiles of existing antihypertensive medicines.
Under the terms of its licensing agreement, George Medicines will receive an upfront licensing fee and is eligible for commercial milestone payments, as well as a future recurring revenue stream through a tiered royalty rate on sales of GMRx2 in the licensed territory. In return, Arrotex is granted a license to exclusively commercialize GMRx2, supplied by George Medicines. Arrotex is responsible for seeking regulatory approval of GMRx2, supported by George Medicines, with upcoming applications to Australia’s Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority.
Mark Mallon, Chief Executive Officer of George Medicines, said:
“This latest partnership in our global commercialization strategy for GMRx2 signals our commitment to extend the reach of this triple combination product to all corners of the globe. The George Institute for Global Health, which founded George Medicines, was established in Australia and so it is a significant moment for us to bring GMRx2 one step closer to people living with hypertension in the Institute’s home country. As Australia's largest pharmaceutical provider, and with its significant commercial capabilities, Arrotex is an ideal partner to support us in delivering on the potential of GMRx2 to help address key challenges in current hypertension treatment approaches.”
Monique Jonson, General Manager, Innovation, at Arrotex Pharmaceuticals, said:
“Our partnership with George Medicines reflects Arrotex’s ongoing commitment to bringing innovative, life-changing therapies to Australia and New Zealand. Through our unprecedented operational and commercial capabilities, we are well placed to facilitate access for patients and look forward to working with the George Medicines team on our upcoming regulatory submissions for GMRx2.”
Around one in three adults in Australia (6.8 million) are living with high blood pressure with only half of those aware of their condition and receiving treatment. More than a million of those diagnosed and treated do not have their blood pressure effectively controlled
1
. In New Zealand, the prevalence of hypertension in adults is 31% (968,000), and only around a quarter have the condition effectively controlled
2
.
Most patients with hypertension will require two or more medicines to bring their blood pressure under control, and globally recognized treatment guidelines acknowledge the preferred use of single pill combination therapy and the benefit of their early use.
3,4,5
To date, George Medicines has granted licensing and supply agreements for GMRx2 in Brazil, Cananda, Mexico, Colombia and Central America, and the United States, with further collaborations anticipated as part of the Company’s commitment to bring the value of this important medicine to patients globally.
George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm.
Ends
National Hypertension Taskforce Australia
2
WHO Hypertension New Zealand 2023 country profile
3
European Heart Journal, Volume 45, Issue 38, 7 October 2024, Pages 3912–4018,
4
Guideline for the pharmacological treatment of hypertension in adults. Geneva:
World Health Organization
; 2021
5
CMAJ May 26, 2025 197 (20) E549-E564;
About GMRx2
GMRx2 is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg.
Its development is backed by a comprehensive clinical program, including two pivotal Phase III studies, published in 2024 in the
Journal of the American College of Cardiology
and
The Lancet
.
In these trials the triple combination demonstrated significantly reduced blood pressure (BP) and improved BP control rates, when compared against dual therapy and against placebo. In both trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events.
GMRx2 was investigated in the Nigerian
VERONICA trial
, which compared the triple combination with standard of care and reported better BP lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol.
A global trial led by The George Institute for Global Health and funded by the National Health and Medical Research Council (NHMRC) Australia and the Brazilian Ministry of Health, investigating the potential of GMRx2 to significantly reduce the risk of recurrent stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) completed in 2025. The study met the primary endpoint, with GMRx2 demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo.
About George Medicines
George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, which remain among the leading causes of premature death and disability worldwide.
For more information, please visit
.
About
Arrotex Pharmaceuticals
Arrotex Pharmaceuticals is the largest and most diversified pharmaceutical company in Australia, offering the most extensive range of prescription products across the spectrum of therapeutic areas. Proudly Australian-owned and part of DBG Health, Arrotex has over 15 years of proven success in representing branded medicines and has become the Australian partner of choice for pharmaceutical companies seeking to grow and protect their brands while enhancing patient access to medicines for Australians.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to George Medicines’ financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential. In addition, this press release also contains forward-looking statements relating to George Medicines’ growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including George Medicines’ ability to successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of drug candidates.
Media contacts
ICR Healthcare
David Daley, Lindsey Neville, Tom Daniel
georgemedicines@icrhealthcare.com
; Tel: +44 (0) 203 709 5700
临床结果引进/卖出临床3期
2026-03-11
George Medicines signs exclusive licensing agreement with Ahngook Pharmaceutical to commercialize GMRx2 in Korea
GMRx2 is an innovative single pill combination of three medicines designed to deliver the blood pressure-lowering benefits of triple combination therapy early in the treatment pathway, supported by an established safety profile
George Medicines receives upfront licensing fee and is eligible for regulatory and commercial milestone payments, as well as a future recurring revenue stream through stepped royalties on sales in Korea
Fifth major licensing and supply agreement for GMRx2 as George Medicines expands commercialization strategy to advance cardiovascular care
London, UK, 11 March 2026
– George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, has entered into an exclusive licensing and supply agreement with Ahngook Pharmaceutical Co. Ltd (“Ahngook Pharm”) (KOSDAQ: 001540), of Seoul, Korea, granting Ahngook Pharm exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Korea.
GMRx2 is an innovative single pill combination of three medicines, telmisartan, amlodipine and indapamide, for the treatment of hypertension in adults, developed in three doses, including two doses that are lower than those currently available in single pill combinations. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the safety pro established antihypertensive medications.
Under the terms of the licensing agreement, George Medicines will receive an upfront licensing fee from Ahngook Pharm and is eligible for regulatory and commercial milestone payments, as well as a future recurring revenue stream through a stepped royalty rate on sales of GMRx2 in the licensed territory. In return, Ahngook Pharm is granted a license to exclusively commercialize GMRx2, supplied by George Medicines. Ahngook Pharm is responsible for seeking regulatory approval of GMRx2, with support from George Medicines.
Mark Mallon, Chief Executive Officer of George Medicines, said:
“In Ahngook Pharmaceutical we have a strong commercial partner who shares our belief in the potential of GMRx2 to help address key challenges in current hypertension treatment approaches. Through our partnership we have an opportunity to advance cardiovascular care, and we look forward to working with the team to support GMRx2’s regulatory approval in Korea.”
Park In-choul, Chief Executive Officer of Ahngook Pharmaceutical, said:
“This agreement expands our cardiovascular portfolio and signals our continued commitment to improve outcomes for patients. We look forward to working with George Medicines to bring this important treatment option to patients in Korea.”
George Medicines continues to build its global commercialization strategy for GMRx2, with this latest collaboration following licensing and supply agreements with Azurity Pharmaceuticals in the US, Bausch Health in Canada, Mexico, Colombia and Central America, Biolab Farmacêutica in Brazil, and Orient EuroPharma in Southeast Asia. These partnerships demonstrate George Medicines’ commitment to bringing the proven clinical efficacy and established safety pro GMRx2 to patients worldwide.
George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm.
Ends
About GMRx2
GMRx2 is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg.
Its development is backed by a comprehensive clinical program, including two pivotal Phase III studies, published in 2024 in the
Journal of the American College of Cardiology
and
The Lancet
.
In these trials the triple combination demonstrated significantly reduced blood pressure (BP) and improved BP control rates, when compared against dual therapy and against placebo. In both trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events.
GMRx2 was investigated in the Nigerian
VERONICA trial
, which compared the triple combination with standard of care and reported better BP lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol.
A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing.
About George Medicines
George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, which remain among the leading causes of premature death and disability worldwide.
For more information, please visit
.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to George Medicines’ financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential. In addition, this press release also contains forward-looking statements relating to George Medicines’ growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including George Medicines’ ability to successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of drug candidates.
Media contacts
ICR Healthcare
David Daley, Lindsey Neville, Tom Daniel
georgemedicines@icrhealthcare.com
; Tel: +44 (0) 203 709 5700
引进/卖出临床3期AHA会议
2026-02-27
·泓博医药
本期快讯简要聚焦：临床方面，吉利德 HIV 每日一次单片复方制剂三期数据优异，Rgenta 披露口服 PMS1 抑制剂治疗亨廷顿舞蹈症潜力；公司动态涵盖 GSK 以 9.5 亿美元收购 35Pharma 布局肺高压领域，诺华扩建美放射药生产基地，诺和诺德联手 Vivtex 研发口服减重药，George Medicines 推进三联高血压药东南亚商业化；监管层面，Curanex 更新核心管线审批节点。多维热点交织，勾勒全球医药产业最新脉动。
01
临床试验
01
吉利德公布两项后期临床数据，验证其每日一次 HIV 单片复方制剂的疗效
吉利德科学（Gilead）披露了两项关键 3 期临床研究（ARTISTRY-1 和 ARTISTRY-2）的最新数据，旨在评估其由整合酶抑制剂必妥维（Bictegravir）与 Lenacapavir 组成的每日一次单片复方制剂（STR）。研究结果显示，在接受该 STR 治疗的病毒抑制型 HIV-1 感染者中，其疗效与继续接受现有抗逆转录病毒疗法相当，成功达到了主要终点。这一进展标志着吉利德在简化 HIV 治疗方案、提高患者依从性方面迈出了重要一步，进一步巩固了其在抗病毒领域的领导地位。
关键词：吉利德，HIV，Lenacapavir，临床 3 期
https://www.fiercepharma.com/pharma/gilead-paints-clearer-picture-bictegravir-lenacapavir-single-tablet-combos-prowess-varied
02
Rgenta Therapeutics 发布临床前数据，展示口服 PMS1 抑制剂治疗亨廷顿舞蹈症的潜力
Rgenta Therapeutics 在近期学术会议上展示了其新型候选药物 RGT-0474060 的临床前研究成果。该药物被定义为一种具有前景的口服 PMS1 抑制剂，专门用于治疗亨廷顿舞蹈症（HD）。临床前数据显示，RGT-0474060 能够通过靶向 RNA 加工机制有效调节致病基因表达，并在动物模型中观察到了良好的安全性与药代动力学特性。这一发现为针对亨廷顿舞蹈症这种高度致残的神经退行性疾病提供了全新的治疗策略和靶点选择。
关键词： Rgenta，PMS1 抑制剂，亨廷顿舞蹈症，临床前研究
https://www.globenewswire.com/news-release/2026/02/25/3244536/0/en/Rgenta-Therapeutics-Presents-Preclinical-Data-Unveiling-its-New-Drug-Candidate-RGT-0474060-as-a-Promising-Oral-PMS1-Inhibitor-for-the-Treatment-of-Huntington-s-Disease.html
02
公司动态
01
GSK 耗资 9.5 亿美元收购 35Pharma，加码心血管及肺高压管线布局
葛兰素史克（GSK）宣布已达成协议，以 9.5 亿美元现金预付款收购加拿大生物技术公司 35Pharma。此次交易的核心资产是一款类似于默沙东 Winrevair 的高血压药物。该候选药物主要针对激活素（Activin）信号通路，旨在治疗肺动脉高压（PAH）等严重心血管疾病。GSK 此举意在通过收购具有差异化竞争力的资产，迅速填补其在特药领域的增长需求，挑战默沙东在这一细分市场的垄断地位。
关键词：GSK，35Pharma，肺动脉高压，并购
https://www.fiercebiotech.com/biotech/gsk-pays-950m-cash-canadian-biotech-and-its-winrevair-blood-pressure-drug
02
诺华扩建美国德克萨斯州放射药物生产基地，推进 230 亿美元投资计划
诺华（Novartis）宣布在德克萨斯州设立新的放射性药物生产基地，作为其在美国大规模投资蓝图的一部分。此举旨在完善其全球放射配体疗法（RLT）的供应链体系，以支持其重磅产品 Pluvicto 和 Lutathera 的市场供应。随着放射药物在肿瘤治疗中的地位日益凸显，诺华正通过在美累计投入约 230 亿美元的“闪电战”式布局，确保在这一高技术壁垒领域的生产优势及市场领先地位。
关键词： 诺华，放射药物，Pluvicto，产能扩张
https://www.fiercepharma.com/pharma/novartis-rounds-out-radiopharmaceutical-plans-amid-broader-23b-us-investment-blitz
03
诺和诺德与 Vivtex 达成合作，致力于开发新一代口服肥胖与糖尿病药物
诺和诺德（Novo Nordisk）与 Vivtex 宣布达成战略合作伙伴关系，共同开发针对肥胖和糖尿病的创新口服制剂。Vivtex 拥有独特的人体器官芯片技术平台，能够精确模拟肠道吸收过程。通过此次合作，诺和诺德希望利用该平台克服生物大分子药物口服吸收的生物学障碍，开发出疗效更强且便捷性更高的下一代代谢类药物。这对于诺和诺德维持其在减重药物市场的竞争优势具有重要战略价值。
关键词：诺和诺德，Vivtex，口服减重药，技术平台
https://www.biopharmadive.com/news/vivtex-novo-nordisk-oral-obesity-drugs-biologics/812754/
04
George Medicines 与东方药业签署协议，在东南亚商业化高血压三合一复方制剂
George Medicines 近日宣布与东方药业（Orient EuroPharma）达成独家许可协议，旨在东南亚市场推广其创新高血压三合一候选药物 GMRx2。GMRx2 将三种常用抗高血压药物以超低剂量组合，研究表明其在降低血压方面的效率显著优于标准单药或双联疗法，且副作用更低。此次合作是 George Medicines 全球商业化战略的重要一环，将有助于该疗法在心血管疾病负担沉重的东南亚地区实现快速覆盖。
关键词： George Medicines，GMRx2，高血压，东南亚市场
https://www.globenewswire.com/news-release/2026/02/25/3244483/0/en/George-Medicines-advances-its-global-commercial-strategy-for-GMRx2-with-an-exclusive-licensing-agreement-with-Orient-EuroPharma-in-Southeast-Asia.html
03
监管政策
01
Curanex 提供核心监管里程碑运营更新，推进在研管线上市进程
Curanex 公司今日发布了关于其核心候选产品在主要市场监管审批进度的官方声明。报告详述了公司在与 FDA 及 EMA 等监管机构沟通中的最新进展，包括关键性临床研究的数据提交时间表以及预期的监管反馈节点。Curanex 强调，公司正致力于按计划达成这些合规目标，以确保创新疗法能够尽快获批上市。这一更新为投资者和行业观察者提供了关于该公司产品管线确定性的重要参考依据。
关键词：Curanex，监管里程碑，FDA，上市审批
https://www.globenewswire.com/news-release/2026/02/25/3244564/0/en/Curanex-Provides-Operational-Update-on-Key-Regulatory-Milestones.html
END
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10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 高血压 | 美国 | 2025-06-05 |
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10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 脑出血 | 临床3期 | 澳大利亚 | 2020-02-27 | |
| 脑出血 | 临床3期 | 荷兰 | 2020-02-27 | |
| 脑小血管疾病 | 临床3期 | 澳大利亚 | 2020-02-27 | |
| 脑小血管疾病 | 临床3期 | 荷兰 | 2020-02-27 | |
| 血管性痴呆 | 临床3期 | 澳大利亚 | 2020-02-27 | |
| 血管性痴呆 | 临床3期 | 荷兰 | 2020-02-27 | |
| 出血性卒中 | 临床3期 | 澳大利亚 | 2020-02-27 | |
| 出血性卒中 | 临床3期 | 荷兰 | 2020-02-27 |
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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 |
|---|
N/A | - | 鹹壓壓鹽遞遞夢衊衊膚(淵簾鬱醖選構糧鏇廠襯) = The study met the primary endpoint, with GMRx2 demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo. 憲餘窪製繭鏇醖築積衊 (構衊願遞餘構顧衊觸醖 ) 达到 更多 | 积极 | 2025-10-23 | |||
临床3期 | - | Widaplik 40 mg/5 mg/2.5 mg | 鹽製鏇餘網廠壓選醖壓(鬱鬱廠餘鑰醖遞鬱壓膚) = 醖簾憲願夢衊淵蓋願獵 範壓艱繭鬱鏇艱範廠夢 (淵壓蓋夢簾遞膚選蓋夢, 0.5) 更多 | 积极 | 2025-06-05 | ||
鹽製鏇餘網廠壓選醖壓(鬱鬱廠餘鑰醖遞鬱壓膚) = 衊壓艱餘範憲齋觸構淵 範壓艱繭鬱鏇艱範廠夢 (淵壓蓋夢簾遞膚選蓋夢, 0.5) 更多 | |||||||
临床3期 | 295 | 獵膚網齋遞蓋餘齋齋膚(膚壓糧衊簾襯糧製網艱) = 壓廠繭構觸鹽醖窪鑰淵 構築壓繭積廠鬱壓齋憲 (衊構淵製蓋獵積襯鑰鏇, 1.0) 更多 | 积极 | 2025-06-05 | |||
獵膚網齋遞蓋餘齋齋膚(膚壓糧衊簾襯糧製網艱) = 築積鹽構窪膚簾築願糧 構築壓繭積廠鬱壓齋憲 (衊構淵製蓋獵積襯鑰鏇, 1.3) 更多 | |||||||
临床3期 | 295 | GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg) | 衊襯繭鹹繭願鹹網鹽構(鑰簾憲淵鑰繭築憲餘夢) = 顧鬱糧鹽觸淵網壓製醖 衊壓鬱艱窪廠製積淵壓 (範繭膚積獵憲鏇獵襯鏇, -4.5 ~ -10.2) 更多 | 积极 | 2024-12-01 | ||
GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg) | 衊襯繭鹹繭願鹹網鹽構(鑰簾憲淵鑰繭築憲餘夢) = 餘鹽觸膚積構膚繭鹽築 衊壓鬱艱窪廠製積淵壓 (範繭膚積獵憲鏇獵襯鏇, -5.2 ~ -11.3) 更多 |
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