Open-label, Randomised, 4 Parallel-group, Phase I Clinical Trial to Investigate BI 456906 Occupancy of Glucagon Receptors in Liver and Glucagon-like Peptide 1 Receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjects With Obesity Using PET and MRI

This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas. These receptors are involved in appetite and weight regulation. To measure the occupancy of these receptors, doctors use injectable tracers. Doctors visualise the binding of the tracers to these receptors with imaging methods.
Participants are put into 4 groups randomly, which means by chance. 2 groups get BI 456906 and 2 groups get semaglutide. Semaglutide is an approved medicine for body weight reduction. For 17 weeks, participants get injections under the skin. They either get BI 456906 twice a week or semaglutide once a week. The injected doses increase in small steps. Before and after 17 weeks of treatment, the receptor occupancy is determined.
Participants are in the study for up to 6 months. At the beginning and at the end of the treatment participants stay at the study site with an overnight stay. At the beginning, the study staff trains participants how to inject the study treatment at home. Participants who get BI 456906 visit the study site 18 times and have 19 visits at home. Participants who get semaglutide visit the study site 15 times and have 6 home visits. The doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2024-11-01

申办/合作机构

Boehringer Ingelheim GmbH

NCT06632444 / Recruiting临床3期

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

This study is open to adults who are at least 18 years old and have:
* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic-associated steatohepatitis (MASH) and
* moderate or advanced liver fibrosis
People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.
This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.

开始日期2024-10-14

申办/合作机构

Boehringer Ingelheim GmbH

NCT06632457 / Recruiting临床3期

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

This study is open to adults who are at least 18 years old and have:
* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
* BMI of 27 kg/m2 or more or
* 25 kg/m2 or more if the participant is Asian.
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

开始日期2024-10-02

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Survodutide 相关的临床结果

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100 项与 Survodutide 相关的转化医学

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100 项与 Survodutide 相关的专利（医药）

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项与 Survodutide 相关的文献（医药）

2024-11-01·DIABETES CARE

Efficacy and Safety of GLP-1 Medicines for Type 2 Diabetes and Obesity

Review

作者: Drucker, Daniel J.

The development of glucagon-like peptide 1 receptor agonists (GLP-1RA) for type 2 diabetes and obesity was followed by data establishing the cardiorenal benefits of GLP-1RA in select patient populations. In ongoing trials investigators are interrogating the efficacy of these agents for new indications, including metabolic liver disease, peripheral artery disease, Parkinson disease, and Alzheimer disease. The success of GLP-1–based medicines has spurred the development of new molecular entities and combinations with unique pharmacokinetic and pharmacodynamic profiles, exemplified by tirzepatide, a GIP-GLP-1 receptor coagonist. Simultaneously, investigational molecules such as maritide block the GIP and activate the GLP-1 receptor, whereas retatrutide and survodutide enable simultaneous activation of the glucagon and GLP-1 receptors. Here I highlight evidence establishing the efficacy of GLP-1–based medicines, while discussing data that inform safety, focusing on muscle strength, bone density and fractures, exercise capacity, gastrointestinal motility, retained gastric contents and anesthesia, pancreatic and biliary tract disorders, and the risk of cancer. Rapid progress in development of highly efficacious GLP-1 medicines, and anticipated differentiation of newer agents in subsets of metabolic disorders, will provide greater opportunities for use of personalized medicine approaches to improve the health of people living with cardiometabolic disorders.

2024-11-01·JOURNAL OF HEPATOLOGY

Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis

Article

作者: Schmid, Bernhard ; Noureddin, Mazen ; Fraessdorf, Mandy ; Andrews, Charles P ; Alkhouri, Naim ; Hosseini-Tabatabaei, Azadeh ; Neff, Guy W ; Schattenberg, Jörn M ; Gane, Edward J ; Sanyal, Arun J ; Mazo, Daniel F ; Fenske, Wiebke K ; Lawitz, Eric J ; Younes, Ramy ; Takács, István ; Hussain, Samina Ajaz

BACKGROUND & AIMS:

Survodutide is a glucagon/glucagon-like peptide-1 receptor dual agonist in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). We investigated the pharmacokinetic and safety profile of survodutide in people with cirrhosis.

METHODS:

This multinational, non-randomized, open-label, phase I clinical trial initially evaluated a single subcutaneous dose of survodutide 0.3 mg in people with Child-Pugh class A, B or C cirrhosis and healthy individuals with or without overweight/obesity matched for age, sex, and weight; the primary endpoints were the area under the plasma concentration-time curve from 0 to infinity (AUC_0-∞) and maximal plasma concentration (C_max). Subsequently, people with overweight/obesity with or without cirrhosis (Child-Pugh class A or B) received once-weekly subcutaneous doses escalated from 0.3 mg to 6.0 mg over 24 weeks then maintained for 4 weeks; the primary endpoint was drug-related treatment-emergent adverse events, with MASH/cirrhosis-related endpoints explored.

RESULTS:

In the single-dose cohorts (n = 41), mean AUC_0-∞ and C_max were similar in those with cirrhosis compared with healthy individuals (90% CIs for adjusted geometric mean ratios spanned 1). Drug-related adverse events occurred in 25.0% of healthy individuals and ≤25.0% of those with cirrhosis after single doses, and 82.4% and 87.5%, respectively, of the multiple-dose cohorts (n = 41) over 28 weeks. Liver fat content, liver stiffness, liver volume, body weight, and other hepatic and metabolic disease markers were generally reduced after 28 weeks of survodutide treatment.

CONCLUSIONS:

Survodutide is generally tolerable in people with compensated or decompensated cirrhosis, does not require pharmacokinetic-related dose adjustment, and may improve liver-related non-invasive tests, supporting its investigation for MASH-related cirrhosis.

IMPACT AND IMPLICATIONS:

Survodutide is a glucagon receptor/glucagon-like peptide-1 receptor dual agonist in development for treatment of metabolic dysfunction-associated steatohepatitis (MASH), which causes cirrhosis in ∼20% of cases. This trial delineates the pharmacokinetic and safety profile of survodutide in people with compensated or decompensated cirrhosis, and revealed associated reductions in liver fat content, markers of liver fibrosis and body weight. These findings have potential relevance for people with MASH-including those with decompensated cirrhosis, who are usually excluded from clinical trials of investigational drugs. Based on this study, further investigation of survodutide for MASH-related cirrhosis is warranted.

CLINICALTRIALS:

GOV IDENTIFIER:

NCT05296733.

2024-10-01·Current diabetes reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity

Review

作者: Aliter, Hashem F. ; Al-Horani, Rami A. ; Aliter, Kholoud F.

Abstract::

Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity

219

项与 Survodutide 相关的新闻（医药）

2024-11-13

·CPHI制药在线

没有买卖就没法洗牌，减肥并购中的买家卖家

关注并星标CPHI制药在线减肥药开发是医药行业目前最大的热点之一，甚至有分析机构预测，减肥药市场未来的规模将发展到2000亿美元的水平，几乎可以和目前的肿瘤学产品比肩，因此众多生物医药和科技公司都渴望跻身这个拥有巨大开发潜力的市场之中。诺和诺德的减肥药Wegovy今年第三季度获得了25亿美元的销售业绩，预计明年将拿下130亿美元的全球销售额，并一举跻身重磅炸弹前十名的榜单。在这样一片大好的局面下，即便诺和的Wegovy和礼来的Zepbound把持了目前减肥药市场的绝大部分市场，但仍然有一干减肥药开发商抱着“野芳虽晚不须嗟”的信念在开发减肥药的道路上大干快上。而在另一块平行战场上，减肥药项目和企业的收购竞争也在经历激烈的明争暗斗。最新的大热收购目标是12年前创立的总部位于加州圣迭戈的Viking Therapeutics。 Viking Therapeutics 的口服多肽减肥药 VK2735 在 1 期临床试验中表现出较高的有效性和安全性，吸引了行业的广泛关注。VK2735 是一种双重 GLP-1/GIP 受体激动剂。在其I期研究中，受试者的体重显著下降，并且VK2735表现出了良好的安全性和耐受性。在 100 mg 的最高剂量组中，VK2735 实现了安慰剂调整后28天6.8%的减重率，这个数据令行业侧目。众多分析师在看好VK2735未来的同时，也纷纷认为Viking Therapeutics将成为制药业巨头收购的下一个热点。 Viking没有稳定的资金注入，独自完成VK2735上市的目标稍显艰巨，尤其是考虑到口服版本的研究仍然处于I期，皮下注射的临床也只是II期，因此需要大量资金的注入才有可能实现产品的上市。之前Viking似乎一直处于“待价而沽”的状态，等待的似乎就是关键里程碑的实现。而如今I期口服制剂数据的出炉似乎就是最好的时机，因此Viking的收购成为了越来越接近现实的交易。包括辉瑞和阿斯利康在内的多家大型公司在内，他们收购减肥药资产或公司的意愿早已不是秘密。阿斯利康从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004恰好也是一款口服制剂，但不同于VK2735，AZD5004是一款小分子药物。阿斯利康也在近期的ObesityWeek 2024会议上公布了AZD5004的I期数据，显示出5.8%的四周减重率。因此阿斯利康继续收购口服减肥药资产的意愿可能没有那么强烈。而辉瑞在终止了其小分子GLP-1口服减肥药资产lotiglipron之后，又终止了另一款口服小分子减肥药danuglipron每日两剂的临床研究，目前只剩下danuglipron的每日一剂肥胖症项目，因此收购意图可能更为强烈。除了Viking Therapeutics之外，作为“收购靶点”的公司还包括下列减肥候选药资产拥有者： Structure Therapeutics • 总部：美国加州南旧金山 • 成立时间：2021年 • 市值（2024年11月6日值，下同）：22亿美元 • 主要减肥药资产：Aleniglipron（又名GSBR-1290口服GLP-1受体激动剂），II期数据公布 • 收购看点：Aleniglipron的II期数据与礼来小分子口服GLP-1减肥候药orforglipron可比（12周安慰剂调整后减重率6.2%），但停药率可能较低。小分子口服药具有明显的成本优势，因此代表了减肥药开发的下一波热点。那些拥有口服减肥药资产，且已经产生了不错临床中后期数据的中小公司必然会成为收购重点。 • 收购阻碍：开发位置看上去至少落后orforglipron一年。在机制相同、疗效相近、模态一样的情况下，时间线决定了未来的市场地位和如今的收购价值。 Altimmune Inc. • 总部：美国马里兰州Gaithersburg • 成立时间：1997年 • 市值：5.1亿美元 • 主要减肥药资产：Pemvidutide（每周注射一次多肽GLP-1/胰高血糖素双受体共激动剂），III期研究中。 • 收购看点：长期减重率略优于Wegovy。2.4 mg pemvidutide 48周减重率15.6%。Pemvidutide同时对代谢障碍相关脂肪型肝炎（MASH）进行临床研究。 • 收购障碍：20% 的停药率可能是一个限制因素，但随着患者进入第 3 阶段，允许剂量减少，这应该会对耐受性所有帮助。 Zealand Pharma • 总部：丹麦哥本哈根 • 成立时间：1999年 • 市值：87.6亿美元 • 主要减肥药资产：Survodutide（每周注射一次的多肽GLP-1/胰高血糖素双受体共激动剂），III期临床进行中，授权勃林格殷格翰开发；Dapiglutide（GLP-1/GLP-2共激动剂），II期进行中；Petrelintide（胰淀素类似物），II期进行中。 • 收购看点：Zealand Pharma将根据survodutide全球销售额获取10%左右的版税；项目已经进入III期，有望成为首批Wegovy和Zepbound的挑战者；46周19%减重率；针对MASH开发获得FDA突破性疗法头衔；同时拥有新颖机制的GLP-1/GLP-2双受体共激动剂中期资产，以及胰淀素激动剂中期资产petrelintide。Zealand Pharma在不久前的ObesityWeek 2024会议中公布了petrelintide的I期数据，引发了广泛关注。多次递增剂量 I 期试验数据显示，在16周每周注射一次（剂量分别为 2.4 mg, 4.8 mg 和 9.0 mg）后，平均体重减轻 4.8%、8.6% 和 8.3%，而合并安慰剂组减轻 1.7%。这显示了petrelintide不仅在机制上能够填补目前减肥药的空白，在实际疗效上可能也具备了未来与semaglutide和tirzepatide分庭抗礼的潜力。美国银行分析师表示，他们预计petrelintide将主要用于 GLP-1 不耐受或失败市场（约占 20% 的患者），并预计其年销售额将达到 80 亿美元的峰值。 • 收购障碍：自身被收购意愿可能较低，但Zealand Pharma已经表达出了正在寻找共同开发petrelintide的合作伙伴的动态。与授权survodutide的模式不同，Zealand Pharma将参与petrelintide的开发与商业化的整个过程。Zealand Pharma的CEO表示，目前已就petrelintide的潜在合作开发与前十大制药企业中的一家产生了关联，但不肯透露更多的消息。 Fractyl Health • 总部：美国马萨诸塞州Burlington • 成立时间：2010年 • 市值：1.1亿美元 • 主要减肥药资产：Revita（一种门诊内窥镜手术，通过热液消融持久改变十二指肠功能障碍，从而恢复代谢健康。有证据表明，Revita 可能为肥胖和 2 型糖尿病患者提供持久的体重维持和改善血糖控制。针对接受 GLP-1 药物治疗体重至少减轻 15% 并希望停止使用 GLA-1 药物而不反弹的患者进行临床研究）；Rejuva （一种新型局部给药 AAV 基因疗法，目前处于临床前开发阶段，可改善胰岛功能。通过改变患者的胰腺胰岛细胞中的代谢激素反应，实现持久的体重减轻和 2 型糖尿病的长期缓解。） • 收购看点：提供长期体重管理的方案 • 收购障碍：特殊治疗后产生的不良反应潜在肥胖症资产和公司买家 • 默沙东（收购意愿：高）：默沙东的药王Keytruda将在2028年专利到期，默沙东对代谢类疾病表现出了高度兴趣，但缺乏GLP-1管线资产。 • 诺和诺德（收购意愿：高）：诺和诺德一直在通过资产购买的方式巩固自己在代谢疾病领域的领先地位。 • 辉瑞（收购意愿：中/高）：辉瑞一直在努力开发口服减肥药，但屡遭挫折。目前几乎硕果仅存的GLP-1小分子减肥候选药daniglupron的前景并不被看好，因此在此路不通的情况下，辉瑞可能选择外部资产的引入。 • 强生（收购意愿：中/高）：近期代谢疾病领域的挫折（Xarelto, Invokana, aprocitentan）大大刺激了强生通过收购外部资产的渴望。 • 礼来（收购意愿：高）：与诺和诺德的减肥药“军备竞赛”。 • 阿斯利康（收购意愿：中/高）：从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004令阿斯利康在减肥药竞赛中处于了一个有利的位置。阿斯利康透露出减肥药与Farxiga设计联合疗法的强烈愿望。 • 勃林格殷格翰（收购意愿：高）：BI对于代谢疾病疗法开发具有很高兴趣，其survodutide是从Zealand Pharma获取授权的资产，因此拥有一款独立的减肥药资产对于BI有着强大的吸引力。 • 罗氏（收购意愿：中/高）：最近从Carmot收购GLP-1资产显示了罗氏对开发减肥药的兴趣。罗氏并不算充盈的减肥药管线昭示着可能会有更多的收购项目到来。 • 第一三共（收购意愿：中）：尽管代谢类疾病曾经是第一三共的开发重点，但其目前的核心资产是肿瘤学产品。 • 赛诺菲（收购意愿：中）：赛诺菲的开发中心已经转移到了炎症和免疫产品，但历史上对于代谢疾病的开发可能重燃赛诺菲进军肥胖症的热情。 • 诺华（收购意愿：中）：虽然拥有不少代谢疾病资产，但诺华的核心竞争力在于肿瘤学、免疫学和罕见疾病。 Ref. Malone, E. Top 10 Drugs Q2 2024: Mounjaro Comes Roaring In. Skyrizi Also Makes Its Debut. Scrip. 24. 10. 2024. Structure Therapeutics Reports Positive Topline Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290. Structure Press Release. 03. 06. 2024. Boehringer Ingelheim to advance survodutide into three global Phase III studies in obesity. BI Press Release. 17. 08. 2023. Obesity Drugs: The Next Wave of GLP-1 Competition. New drugs from public and private companies will challenge Novo and Lilly's dominance. Morningstar & PitchBook. Sept. 2024. END 【智药研习社线上研习会报名】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

并购临床1期

2024-11-08

·赛柏蓝

进博时间｜跨国药企明星新药亮相，深耕中国决心不变

“新时代，共享未来”，2024年第七届中国国际进口博览会进行时，跨国药企透过进博会这一窗口继续深耕中国、共创未来。 01 进博会历经7载见证跨国药企创新力量在上海国家会展中心7.2馆，跨国药企悉数亮相，阿斯利康、默沙东、辉瑞、诺和诺德赛诺菲、拜耳、强生、欧加隆、武田、诺华、吉利德、罗氏、GSK、礼来、勃林格殷格翰赫力昂、梯瓦、安进、瑞迪博士...... 第七届进博会上，阿斯利康带来7款中国首展创新药，覆盖肿瘤、呼吸、心血管、自体免疫及罕见病领域。默沙东集中展示了在中国境内已获批的近30种药物和疫苗，覆盖肿瘤、糖尿病、抗感染、罕见病、麻醉等领域。辉瑞在抗感染、罕见病、血液肿瘤领域带来了多款创新产品，其中有3款是首次在中国亮相。分别是：血友病新型疗法HYMPAVZI™（马塔西单抗/marstacimab-hncq）——全球首款只需每周一次固定剂量皮下注射的抗组织因子途径抑制物，可同时满足血友病A及血友病B患者的治疗需求；新型抗菌药物思福诺®（注射用氨曲南阿维巴坦钠）——首个针对金属β-内酰胺酶（MBLs）的β-内酰胺类/β-内酰胺酶抑制剂组合，克服了既往酶抑制剂合剂不能覆盖MBLs的问题；以及针对多发性骨髓瘤的创新药物一种靶向B细胞成熟抗原（BCMA）和CD3的双特异性抗体ELREXFIO™（埃纳妥单抗）等。 2024年是诺和诺德中国30周年，诺和诺德今年在进博会展出15款多疾病领域的创新药品及5款注射装置，其中4款今年刚在中国获批。分别是全球首个胰岛素周制剂——诺和期®（依柯胰岛素注射液）、全球首个口服胰高糖素样肽-1受体激动剂（GLP-1RA）——诺和忻®（司美格鲁肽片）、全球首个用于长期体重管理的胰高糖素样肽-1受体激动剂（GLP-1RA）周制剂——诺和盈®、中国首个长效重组凝血因子‌Ⅷ——诺易特®（注射用培妥罗凝血素α）。作为第一批在中国销售的进口药，阿司匹林解热镇痛制剂在上个世纪30年代进入中国。11月6日，拜耳拜阿司匹灵®新包装上市仪式在第七届进博会上举行，在规格方面，除了之前的每盒30片之外，拜耳推出90片大包装，助力患者长期治疗。处方药领域，拜耳带来心血管、眼科、肿瘤、女性健康领域创新产品，拜耳健康消费品事业部带来康王®米诺地尔搽剂、康王®去屑控油洗发水、凯妮汀®乳酸抑菌凝胶等产品。强生创新制药展出治疗非小细胞肺癌EGFR突变的创新药物Rybrevant®，这是全球首个获批用于治疗非小细胞肺癌的EGFR/MET双特异性抗体。自2018年参加首届进博会以来，诺华已有近40款创新药及适应症在国内获批，今年，诺华首次展示其肾病管线组合，包括全球首创的小分子补体B因子抑制剂Iptacopan和口服内皮素A受体拮抗剂阿曲生坦(Atrasentan)。值得关注的是，这是今年1月诺华收购中国本土生物医药企业信瑞诺医药之后，其肾病产品组合在进博会的首次亮相——该收购扩大了诺华在中国的肾病产品线。 2017年，吉利德正式启动在中国的商业运营，关注的疾病领域覆盖从病毒性肝炎、HIV防治，到抗真菌感染和肿瘤。吉利德在本届进博会展出Lenacapavir，这是全球首个获批的HIV衣壳抑制剂类药物，治疗既往接受过多种治疗方案的多重耐药的HIV-1成人感染者。据悉，吉利德已向中国药品审评部门递交Lenacapavir用于HIV治疗的上市申请。 GSK的首个长效HIV暴露前预防药物艾普特(卡替拉韦注射液)，迎来它在中国获批后的首展。艾普特仅需每年注射最少6次即可实现HIV暴露前预防，大大减轻了HIV预防用药负担。礼来重点展示了其在糖尿病、肥胖、阿尔茨海默病和抗肿瘤等全球关键疾病领域的最新进展。其中，穆峰达®(替尔泊肽注射液)，全球首个且目前唯一获批的葡萄糖依赖性促胰岛素多肽(GIP)/胰高糖素样肽-1(GLP-1)受体激动剂。今年5月替尔泊肽在中国正式获批，用于成人2型糖尿病。今年7月又获批长期体重管理适应症。穆峰达是礼来在体重管理领域在华获批的首个创新药物。作为一家成立于1885年的百年企业，勃林格殷格翰聚焦人用药品、动物保健、生物制药合同开发与生产三大业务。在今年的进博会上，在人用药品领域，勃林格殷格翰重点展示5款以临床需求为导向的创新在研产品，覆盖心肾代谢、肺纤维化、精神健康、肿瘤等多个疾病领域——包括新型溶栓药物原研替奈普酶、抗纤维化在研新疗法nerandomilast、survodutide（GCGR/GLP-1R双激动剂）、zongertinib（新型高选择性HER2酪氨酸激酶抑制剂）、iclepertin (GlyT1抑制剂) 。梯瓦已有120多年的发展历史，拥有包括仿制药、创新药、生物类似药等产品线。梯瓦已向中国引进覆盖中枢神经系统、肿瘤、皮肤管理、抗感染等领域的产品资源，其中创新药Austedo XR® （氘丁苯那嗪缓释片）迎来在华“首秀”，用于治疗成人与亨廷顿病（Huntington's Disease, HD）有关的舞蹈病及迟发性运动障碍（Tardive Dyskinesia, TD）；梯瓦在中国的第二款健康消费品--外用药物Regro密丝高米诺地尔防脱生发液也在今年的进博舞台迎来“首展”。成立于1908年的丹麦药企利奥制药，是一家专注于皮肤疾病的公司。目前，利奥制药在中国已经成为银屑病、特应性皮炎和皮肤感染3个疾病领域的市场领导者。在本届进博会上，利奥制药展出了多个明星产品。首款泡沫剂型银屑病药物Enstilar®，在中国的III期临床试验获得优效性结果，近期已递交上市许可申请（NDA）；此外，“first-in-class”的外用泛JAK抑制剂德戈替尼 (Delgocitinib) 乳膏也在现场展出，该产品于近期在欧盟获批，用于治疗成人中重度慢性手部湿疹（CHE）。德戈替尼 (Delgocitinib) 乳膏的中国三期临床试验正在进行中。 02 在中国为中国跨国药企持续释放深耕中国决心在一众跨国药企的进博展台上，不乏夺目的中国元素——龙、凤、莲花，象征吉祥和繁荣，也表达了跨国药企理解中国、深耕中国的心意。诺华公司中国区总裁兼董事总经理李尧对赛柏蓝表示，中国已经成为全球第二大医药市场，且仍在增长中。诺华对中国医药市场广阔的前景充满信心，并继续加大在华投资。在放射配体疗法这一领域，作为全球领导者，诺华正在将这一疗法引入中国。诺华在去年12月投资6亿元人民币在浙江海盐设立放射性药品生产基地，今年7月已经开始动工建设，预计将在2026年底投入运营。中国是诺华全球第二大市场。2024年上半年，诺华在中国的净销售额同比增长29%，是增长最快的跨国药企之一。 1918年礼来在上海设立第一家海外代表处，从此开启了在中国超越一个世纪的发展历程。进入2024年，礼来持续加码中国市场。 10月11日，礼来中国宣布将投资约15亿元人民币用于其苏州工厂的产能升级，扩大2型糖尿病和肥胖创新药物的生产规模，此项投资也是礼来史上最大幅度全球产能升级计划的重要组成部分。 10 月 15 日，礼来宣布在北京成立中国医学创新中心，并计划设立礼来创新孵化器（Lilly Gateway Labs, LGL），以促进临床研究和加速药物研发进程。 9月27日，赫力昂宣布已与合作伙伴天津医药集团和津药达仁堂集团股份有限公司达成协议，将收购其在中国的合资企业中美天津史克制药有限公司的额外33%的股权，总价为44.65亿元人民币（约合5亿英镑）。待相关批准最终获得后，赫力昂在中美天津史克的持股比例将从55%提高到88%。诺和诺德也在天津继续扩大产能，项目投资约为40亿元，用于无菌制剂扩建项目，整个项目计划于2027年建设完成。 2023年12月，爱施健与山德士（Sandoz）达成重大协议，收购山德士（中国）制药有限公司的全部股权。爱施健集团总部位于南非德班，始于1850年，2015年，爱施健集团在中国成立第一家公司。继收购葛兰素史克(GSK)抗血栓药物和阿斯利康（AZ）麻醉药组合，2017年爱施健集团全面进军中国市场，目前业务覆盖全国31个省市区的3000多家医院。作为全球领先的生物医药企业，梯瓦大中华区商业负责人庞静妍对赛柏蓝表示，未来，梯瓦将从两个方面继续深化“在中国，为中国”战略——加快全球“王牌产品”管线落地；积极深化本土合作，同各界伙伴共同交换优势资源，推进行业高质量发展。在布局中国市场新品策略时，庞静妍表示梯瓦会从两个方面进行考虑：精准洞察需求、扩大惠及范围。梯瓦对中国市场充满信心，中国也是梯瓦国际市场中增长最快的地区之一。基于市场需求，梯瓦以创新特药为切口进入中国市场，提供中国患者未被满足治疗领域亟需的关键治疗，填补临床空白。同时，仿制药仍然是梯瓦的重要产业支柱之一，梯瓦希望能充分发挥品牌优势，在未来也能将更多优质仿制药品带给中国患者。对跨国药企来说，根据市场环境的变化和自身业务的需求进行适时必要的调整是持续发展的关键，回到跨国药企在中国市场的发展，聚焦创新、合作共享已经成为关键动作。

疫苗上市批准申请上市

2024-11-05

·EndPoints

Zealand’s ‘aspirational’ mission for its amylin drug to be first-line in obesity

SAN ANTONIO — Zealand Pharma, hoping to create the next “foundational” therapy for obesity, detailed more Phase 1 data on its amylin analog that was the backbone of a $1 billion raise this summer. Researchers said Zealand’s drug, dubbed petrelintide, led to up to 8.6% mean weight loss in an early-phase trial. Also, all gastrointestinal disorders observed in the study were mild, save for a moderate case of nausea and a moderate incidence of vomiting. The data were presented Tuesday at the annual ObesityWeek conference in Texas. Zealand initially toplined the data in June and quickly raised $1 billion for the “ crown jewel .” Analysts have predicted petrelintide could reach peak sales of $10 billion. At week 16 in the Phase 1, patients on 2.4 mg petrelintide lost a mean 4.8% body weight. The middle-dose group, 4.8 mg, lost the most at 8.6%, and the 9 mg group saw 8.3% reductions, the researchers said. The drop was 1.7% for the placebo cohort. Petrelintide could potentially have GLP-1-like weight loss of 15% to 20% in larger studies, Zealand chief medical officer David Kendall told Endpoints News on the sidelines of the conference. It also believes amylin agonists could help preserve lean muscle mass, an issue that has come up with the GLP-1 class. The company will dose the first patient in a Phase 2 trial in the coming days or weeks, Kendall said. The study will “elucidate” the differences between the 4.8 mg and 9 mg doses, he said. Zealand is positioning the drug as a potential standalone replacement for GLP-1s or as the first medicine that patients go to for obesity, but the company isn’t excluding the opportunity to combine with GLP-1s or other mechanisms, Kendall said. Novo Nordisk and Eli Lilly have dominated the field so far, but their GLP-1-based medicines carry GI tolerability baggage, among other challenges. Rather than suppress appetite and give patients a “food aversion” signal like the GLP-1s, amylin emphasizes the satiety signal, Kendall said. In his career, he’s worked in both the amylin field at Amylin Pharmaceuticals and on GLP-1s and other mechanisms at Lilly. “If you’ve had a meal here in Texas, you know what satiety feels like. That sense of, I’ve had enough, maybe a little bit too much,” Kendall said. “It actually enhances that signal so you don’t have that same food aversion, the lack of interest. So people tend to eat.” Petrelintide has a 240-hour half-life, or about 10 days, Kendall said. Novo, Lilly, AstraZeneca and multiple other drugmakers are also working on amylin. The field awaits a key Phase 3 readout this quarter from Novo’s CagriSema, a combination of the amylin asset cagrilintide and its blockbuster semaglutide. Novo’s amylin drug “will always be tied to semaglutide,” Kendall said. “We see petrelintide as the next potentially foundational class of therapies going forward. I know it seems maybe aspirational to say over and above what is a pretty successful GLP-1-based therapeutic class.” Structure Therapeutics, which plans to start testing its amylin candidate in humans next year, is looking up to Zealand’s progress. “Zealand is probably the pioneer in terms of pushing the monotherapy as part of their strategy,” Structure CEO Raymond Stevens said in an interview on the sidelines of the conference. “Some of the hypothesis is: amylin has the potential for better tolerability by itself, amylin alone, versus GLP-1.” As Zealand works on the Phase 2, it is looking for a large pharma to help carry petrelintide into Phase 3 and make it a standalone drug. With a fresh $1 billion, though, Zealand is “not backs-against-the-wall,” Kendall said. “The most important thing is not just to find someone with lots of people and deep pockets, but someone who believes in the positioning we’ve talked about.” Zealand already has a partner for its lead obesity drug, the Boehringer Ingelheim-allied survodutide, a glucagon/GLP-1 receptor dual agonist.

临床1期临床结果临床3期临床2期

100 项与 Survodutide 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
肝纤维化	临床3期	美国	Boehringer Ingelheim GmbH	2024-10-14
瘢痕	临床3期	-	Boehringer Ingelheim GmbH	2024-10-08
非酒精性脂肪性肝炎	临床3期	美国	Boehringer Ingelheim GmbH	2024-03-13
非酒精性脂肪性肝炎	临床3期	荷兰	Boehringer Ingelheim GmbH	2024-03-13
非酒精性脂肪性肝炎	临床3期	西班牙	Boehringer Ingelheim GmbH	2024-03-13
2型糖尿病	临床3期	美国	Boehringer Ingelheim GmbH	2023-11-15
2型糖尿病	临床3期	中国	Boehringer Ingelheim GmbH	2023-11-15
2型糖尿病	临床3期	日本	Boehringer Ingelheim GmbH	2023-11-15
2型糖尿病	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2023-11-15
2型糖尿病	临床3期	比利时	Boehringer Ingelheim GmbH	2023-11-15

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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


NCT04153929 \| NCT03591718 \| NCT04667377 (1665-P, ADA2024)	临床1/2期	2型糖尿病 \| 肥胖 HbA1c \| insulin sensitivity \| glucose biomarkers ... 更多	-	Survodutide	選糧蓋鬱簾築選觸鏇顧(觸選憲壓獵獵網願襯壓) = 0.4 vs 0.0 築觸鬱糧鑰鏇齋蓋鬱糧 (遞壓夢壓窪襯衊構衊醖 ) 更多	积极	2024-06-14
				Placebo
ADA2024	N/A	-	-	Survodutide 20 nmol/kg	蓋壓糧顧艱襯廠憲襯鬱(糧築觸艱簾構築餘鏇淵) = 75% reduction 鏇繭淵鑰齋齋獵艱餘築 (糧繭範醖鏇鑰鹹觸鹹鑰 ) 更多	-	2024-06-14
NCT04771273 (1404-0043, Pubmed)	临床2期	非酒精性脂肪性肝炎	293	Survodutide 2.4 mg	鬱淵製鬱壓夢鏇餘觸餘(壓鬱膚鑰選糧願鹹鑰淵) = 醖醖鏇顧鹹膚廠鏇襯膚壓鏇淵範選選膚廠廠醖 (蓋齋襯獵淵積製鬱糧選 ) 更多	积极	2024-06-07
				Survodutide 4.8 mg	鬱淵製鬱壓夢鏇餘觸餘(壓鬱膚鑰選糧願鹹鑰淵) = 鹽顧鹹選鑰願鹽膚獵簾壓鏇淵範選選膚廠廠醖 (蓋齋襯獵淵積製鬱糧選 ) 更多
NCT04771273 (Corporate Publications) 人工标引	临床2期	代谢功能障碍相关的脂肪肝病	295	Survodutide	淵觸鏇積願餘蓋簾淵繭(選夢網鹹膚築鹽衊壓鹹) = 齋鹽觸鹹鑰壓繭艱糧艱憲鑰獵壓遞顧繭製積簾 (膚蓋齋醖鏇簾衊衊衊醖 ) 达到	积极	2024-02-26
				placebo	淵觸鏇積願餘蓋簾淵繭(選夢網鹹膚築鹽衊壓鹹) = 繭築膚餘顧鹹壓鏇簾夢憲鑰獵壓遞顧繭製積簾 (膚蓋齋醖鏇簾衊衊衊醖 ) 达到
NCT04771273 (GlobeNewswire) 人工标引	临床3期	非酒精性脂肪性肝炎	-	survodutide	築鑰鹹築鬱艱願淵衊遞(醖獵構壓餘遞衊夢鑰醖) = 夢窪積製鬱顧齋襯糧蓋壓網觸繭築壓襯窪鏇鬱 (糧鬱醖膚鹽淵網鹹襯壓 ) 达到	积极	2024-02-26
				Placebo	築鑰鹹築鬱艱願淵衊遞(醖獵構壓餘遞衊夢鑰醖) = 鬱廠鹽築築範網簾襯簾壓網觸繭築壓襯窪鏇鬱 (糧鬱醖膚鹽淵網鹹襯壓 ) 达到
NCT04667377 (CTgov)	临床2期	肥胖	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	鬱範遞鬱繭憲鬱襯顧窪(鬱鹹衊顧築鹽餘積製積) = 選鹹憲糧鹽齋壓簾範願蓋範範選襯醖鑰選壓觸 (艱鏇選鬱觸衊遞觸夢築, 淵鏇構膚夢築衊積製構 ~ 構製襯醖觸鑰鬱衊鹽鑰) 更多	-	2023-11-02
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	鬱範遞鬱繭憲鬱襯顧窪(鬱鹹衊顧築鹽餘積製積) = 積顧餘壓糧糧膚選壓獵蓋範範選襯醖鑰選壓觸 (艱鏇選鬱觸衊遞觸夢築, 憲簾廠網遞製鬱鏇憲顧 ~ 觸壓願範糧蓋鹹鑰鏇繭) 更多
NCT04667377 (ADA2023) 人工标引	临床2期	超重 \| 肥胖	387	BI 456906 0.6 mg	餘廠獵鹹鑰築憲積選膚(積淵選糧壓鑰夢衊鹹觸) = 廠觸糧構膚觸膚築憲襯鑰壓願製觸壓鏇選糧糧 (鹹積齋餘窪願範窪範壓 ) 更多	积极	2023-06-23
				BI 456906 2.4 mg	餘廠獵鹹鑰築憲積選膚(積淵選糧壓鑰夢衊鹹觸) = 夢廠網襯積膚觸鑰鏇鹽鑰壓願製觸壓鏇選糧糧 (鹹積齋餘窪願範窪範壓 ) 更多
NCT04153929 (Phase II, CTgov)	临床2期	2型糖尿病	413	Placebo (Placebo)	餘淵鏇鏇範壓餘餘膚鏇(鬱簾艱餘夢顧鑰獵窪襯) = 壓網願選遞淵顧蓋艱繭夢蓋壓積艱窪糧鑰遞夢 (糧鏇觸選網夢糧夢構醖, 製襯鬱襯醖壓築齋簾襯 ~ 鹽願範醖鏇衊鏇廠網淵) 更多	-	2022-11-29
				BI 456906 (BI 456906 0.3 mg)	餘淵鏇鏇範壓餘餘膚鏇(鬱簾艱餘夢顧鑰獵窪襯) = 壓構艱壓築繭膚窪廠願夢蓋壓積艱窪糧鑰遞夢 (糧鏇觸選網夢糧夢構醖, 襯壓選選鹽鹽積構範鬱 ~ 網繭築簾鏇鬱範鹹淵衊) 更多
EASD2022	N/A	-	-	BI 456906	繭襯簾積膚齋獵窪簾顧(鑰簾鏇簾齋蓋糧糧繭製) = 壓衊膚觸網鏇製膚醖廠願範選鑰積衊觸選鹹衊 (願醖鹽艱糧鬱淵繭製遞 )	-	2022-09-22
				Semaglutide	繭襯簾積膚齋獵窪簾顧(鑰簾鏇簾齋蓋糧糧繭製) = 壓鹹鏇淵廠廠糧願鹽簾願範選鑰積衊觸選鹹衊 (願醖鹽艱糧鬱淵繭製遞 )
NCT04153929 (Phase II, EASD2022)	临床2期	2型糖尿病	411	BI 456906 0.3 mg qw	襯餘襯遞簾積壓淵壓鹹(積壓襯範艱觸壓餘遞製) = 獵窪遞淵鏇觸艱築遞選膚膚構蓋艱襯鹽鹽廠鑰 (廠範遞遞醖鬱鬱艱繭齋 )	积极	2022-09-21
				BI 456906 0.9 mg qw	襯餘襯遞簾積壓淵壓鹹(積壓襯範艱觸壓餘遞製) = 膚憲膚觸觸艱積鑰鏇鹽膚膚構蓋艱襯鹽鹽廠鑰 (廠範遞遞醖鬱鬱艱繭齋 )