Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months.

开始日期2024-12-01

申办/合作机构

Eli Lilly & Co.

NCT06672549 / Not yet recruiting临床3期

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

开始日期2024-12-01

申办/合作机构

Eli Lilly & Co.

NCT06692348 / Not yet recruiting临床1期

A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants

The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.

开始日期2024-12-01

申办/合作机构

Eli Lilly & Co.

100 项与 Orforglipron 相关的临床结果

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100 项与 Orforglipron 相关的转化医学

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100 项与 Orforglipron 相关的专利（医药）

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项与 Orforglipron 相关的文献（医药）

2024-12-01·METABOLISM-CLINICAL AND EXPERIMENTAL

Seven glucagon-like peptide-1 receptor agonists and polyagonists for weight loss in patients with obesity or overweight: an updated systematic review and network meta-analysis of randomized controlled trials

Review

作者: Li, Mengting ; Cao, Weiling ; Zheng, Guimei ; Deng, Weishang ; Xie, Zeyu ; Liang, Zhuoru

PURPOSE:

This study aimed to provide evidence-based support and a reference for the efficacy and safety of seven glucagon-like peptide-1 (GLP-1) receptor agonists and polyagonists for weight loss in patients with obesity or overweight through a network meta-analysis.

METHODS:

Relevant randomized controlled trials (RCTs) with an intervention duration of at least 16 weeks assessing seven GLP-1 receptor agonists and polyagonists (mazdutide, 6 or 4.5 mg; retatrutide, 12 or 8 mg; tirzepatide, 15 or 10 mg; liraglutide, 3.0 mg; semaglutide, 2.4 mg; orforglipron, 45 or 36 mg; and beinaglutide, 0.2 mg) in patient with obesity or overweight was searched using three databases (Cochrane Library, PubMed, and Embase) from creation to August 30, 2024. The primary outcome was the percentage change in body weight from baseline. Secondary outcomes included changes in waist circumference, hemoglobin A1c, and fasting plasma glucose level from baseline; adverse events, serious adverse events, adverse event withdrawal, and hypoglycemic events. We conducted a frequentist random-effects network meta-analysis to analyze the data extracted from the RCTs using Stata 16.1 software.

RESULTS:

Twenty-seven RCTs of seven GLP-1 receptor agonists and polyagonists and 15,584 patients were included in the network meta-analysis. In terms of efficacy, compared with placebo, retatrutide 12 mg (-22.10 % in body weight and - 17.00 cm in waist circumference), retatrutide 8 mg (-20.70 % and - 15.90 cm), and tirzepatide 15 mg (-16.53 % and - 13.23 cm) were the three most efficacious treatments for reducing body weight and waist circumference. However, these treatments were less effective in patients with type 2 diabetes mellitus (T2DM). In addition, patients with a high body mass index (BMI) or longer treatment cycles exhibited significantly greater weight loss than those with a low BMI or shorter treatment cycles. In terms of safety, patients without T2DM had a higher incidence of adverse events than those with T2DM. None of the interventions increased the incidence of serious adverse or hypoglycemic events (˂54 mg/dL). There was no significant difference in the incidence of adverse event withdrawal for all interventions in head-to-head comparisons. In addition, disparities in race, BMI, and treatment cycles did not significantly increase the incidence of adverse events. Finally, the sensitivity and publication bias analyses indicated that the basic analysis results were reliable.

CONCLUSION:

Retatrutide (both doses) and tirzepatide exhibited superior efficacy compared to other GLP-1 receptor agonists and polyagonists in reducing body weight and waist circumference. Patients without T2DM, those with a high BMI, and individuals undergoing longer treatment cycles demonstrated significantly greater weight loss and reductions in waist circumference. Dual or triple receptor agonists (GLP-1 plus glucose-dependent insulinotropic polypeptide and/or Glucagon receptor) are more effective for weight loss than GLP-1 receptor agonists.

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

2024-09-11·Archives of Endocrinology Metabolism

Effects of once-daily oral orforglipron on weight and metabolic markers: a systematic review and meta-analysis of randomized controlled trials

Review

作者: Sande-Lee, Simone van de ; van de Sande-Lee, Simone ; Hohl, Alexandre ; Chavez, Matheus Pedrotti ; Ferreira, Rafael Oliva Morgado ; Dos Santos, Henrique Vilar ; Pasqualotto, Eric ; Ronsoni, Marcelo Fernando ; Wille, Julia Murbach ; Petris, Ilmar ; Santos, Henrique Vilar dos ; Lütkemeyer, Carine

The aim of this study is to assess the effects of once-daily oral orforglipron on weight and metabolic markers in adult patients. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were systematically searched until February 2024 for randomized controlled trials (RCTs) comparing orforglipron versus placebo or other anti-obesity medications in adult patients. Weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) or risk differences for binary endpoints were computed, with 95% confidence intervals (CIs). Heterogeneity and risk of bias were assessed with I² statistics and Rob-2, respectively. Statistical analyses were performed using R, version 4.2.2. A total of four studies were included, comprising 815 patients, of whom 620 (76.1%) were prescribed orforglipron. Compared with placebo, orforglipron reduced body weight (WMD -6.14 kg, 95% CI -9.62 to -2.66 kg), body mass index (WMD -2.87 kg/m², 95% CI -4.65 to -1.10 kg/m²), and waist circumference (WMD -5.32 cm, 95% CI -9.13 to -1.51 cm). More patients treated with orforglipron than placebo achieved a weight loss of ≥ 5% (RR 3.31, 95% CI 2.23-4.93), ≥ 10% (RR 5.24, 95% CI 2.07-13.31), and ≥ 15% (RR 9.53, 95% CI 1.26-71.89). The most common adverse events were related to the gastrointestinal tract. In this meta-analysis, the use of once-daily oral orforglipron by adult patients was associated with a significant decrease in body weight, as compared with placebo, with an increase in non-severe gastrointestinal adverse events. Phase 3 RCTs are expected to shed further light on the efficacy and safety of once-daily oral orforglipron over the long term.

268

项与 Orforglipron 相关的新闻（医药）

2024-12-09

·PRNewswire

Biolexis Therapeutics Announces Positive Results from Expanded Diet Induced Obesity (DIO) Model Study for BLX-7006

Study Demonstrates 16.6 % at day 7 to 29 % on terminal day 28 Weight Loss and Superior Efficacy Compared to peptide-based approved or clinical stage oral Obesity Drugs in the DIO Model LEHI, Utah, Dec. 9, 2024 /PRNewswire/ -- Biolexis Therapeutics, a leading metabolic drug discovery company focused on improving the lives of patients with chronic metabolic conditions, including obesity, diabetes, and related diseases, today announced the successful completion of an expanded diet -induced obesity (DIO) trial for its candidate drug, BLX-7006. The results demonstrate significant weight loss and superior efficacy compared to leading obesity therapies, including Semaglutide and Orforglipron, providing robust support for BLX-7006's potential as a transformative treatment for obesity & diabetic indications. The newly completed study builds upon a previous DIO study in which BLX-7006 demonstrated a promising 15.6 % weight loss. In the expanded study, BLX-7006 achieved a substantial 29% weight loss, attributed to evaluating higher dosage levels. These higher doses were well tolerated, with no observed toxicity, marking an important milestone in the development of BLX-7006 for obesity management. "We are extremely encouraged by the results of our expanded DIO study, which show a significant improvement in weight loss with BLX-7006 compared to our initial study," said Dr. Hariprasad Vankayalapati, Chief Scientific Officer at Biolexis Therapeutics. "The higher dosage levels are well tolerated, have yielded a 29% weight loss, which is not only a strong indication of the potential therapeutic benefits of BLX-7006, but also underscores its safety profile, with no evidence of toxicity at these elevated doses in non-clinical animal models. Our findings place BLX-7006 in a competitive position in the obesity treatment space." In addition to the DIO study, Biolexis has completed a non-human primate study to assess BLX-7006's oral bioavailability profile. The study demonstrated high exposure levels, further validating BLX-7006's potential translation into future human clinical trials. "These results are a testament to the strength of our BLX-7006 program and the dedication of our team in developing novel metabolic therapeutics," said Keith Marmer, Chief Business Officer of Biolexis Therapeutics. "With the growing global prevalence of obesity and related metabolic disorders, there is a pressing need for more effective oral treatments over current injectables. The compelling results from both our expanded DIO study and the non-human primate study position BLX-7006 as a promising future clinical candidate to address this critical unmet need." Biolexis will present these findings and additional data at the upcoming Innovation in Obesity Therapeutics Summit in San Diego, CA, on December 11-12, 2024. Biolexis Co-founder Dr. David Bearss will present the latest data on BLX-7006's efficacy and its potential to provide a safe, effective, and oral alternative for patients struggling with obesity and related metabolic conditions. "We are excited to share these groundbreaking results with the scientific community at the Innovation in Obesity Therapeutics Summit," said Dr. Bearss. "As we continue to advance BLX-7006 through clinical development, we remain committed to improving patient outcomes and bringing innovative solutions to the market that can have a meaningful impact on the lives of those affected by chronic metabolic diseases." About Biolexis Therapeutics Biolexis Therapeutics is a biopharmaceutical company focused on discovering and developing innovative metabolic drugs to address chronic diseases such as obesity, diabetes, and related conditions. The company's pipeline includes novel small-molecule oral therapies designed to improve patient outcomes with enhanced efficacy and safety profiles. Biolexis is committed to advancing the treatment of chronic metabolic disorders to enhance patients' lives worldwide. For more information about Biolexis Therapeutics and its pioneering research, please visit biolexistx.com. Forward-Looking Statements This press release contains forward-looking statements regarding the clinical development of BLX-7006, including its potential safety, efficacy, and market positioning. These statements are based on current expectations and are subject to risks and uncertainties. Actual results may differ materially from those anticipated due to various factors, including clinical trial results, regulatory approval, and market conditions. SOURCE Biolexis Therapeutics Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-12-07

·药渡

代谢疾病多肽药物盘点：肥胖/减重适应症进展情况汇总

来源：易贸医疗内容团队多肽具备高活、低毒、低免疫原性等优势，随着GLP-1大单品的市场带动，以及减肥、阿尔茨海默、NASH等更多慢性病适应症的拓展，多肽药物呈现出广阔的市场前景和巨大的发展潜力。本文盘点了部分代谢疾病-肥胖/减重适应症多肽药物的近期进展，也欢迎大家在评论区进行补充~ 肥胖/减重适应症（不完全）利拉鲁肽注射液华东医药首款GLP-1靶点上市产品，已获批用于降糖和减重。贝那鲁肽贝那鲁肽注射液采用了基因工程串联表达技术制备，与人体天然的GLP-1氨基酸序列完全相同，这意味着贝那鲁肽高亲合力和低免疫原性的特点，对应显著的疗效和更佳的安全性。司美格鲁肽/司美格鲁肽片剂司美格鲁肽是一款新型长效GLP-1类似物，可以有效抑制胰高血糖素的释放，从而达到降低血糖的作用。因其体内半衰期在1周左右，实现每周给药一次，迅速取代了上一代降糖药。但是截至目前，口服司美格鲁肽尚未在任何国家和地区获批减重适应症。不过，已有口服司美格鲁肽针对减肥适应症的OASIS 3研究在中国开展。替尔泊肽适用于肥胖（BMI在30及以上）或超重（BMI在27以上，但伴有至少一种体重相关合并症，例如高血压、2型糖尿病或高胆固醇）的成年人减肥，与降低饮食热量和增加运动一起管理体重。 DR10624 是一种FGF21R/GCGR/GLP-1R三靶点多重激动剂，目前正在新西兰开展肥胖合并高甘油三酯血症的Ib/IIa期临床试验，同时在中国启动了针对重度高甘油三酯血症的II期临床。DR10624还获批在中国开展针对代谢相关脂肪性肝病/脂肪性肝炎适应症的临床试验。 HDM1002 已完成中国SAD（单剂量递增）和MAD（多剂量递增）试验，并进入II期临床研究阶段。 HDM1005 HDM1005注射液已获得国家药品监督管理局（NMPA）的四项临床默示许可，适应症涵盖2型糖尿病以及超重或肥胖人群的体重管理。玛仕度肽 Mazdutide 该产品已在多项临床研究中展现出良好的减重和降糖疗效，以及降低腰围、血脂、血压、血尿酸、肝酶及肝脏脂肪含量，以及改善胰岛素敏感性，带来多重代谢获益。诺利糖肽 Noiiglutide 一天一次皮下注射，其糖尿病和肥胖适应症的II期临床均已完成，剂量递增试验的结果显示，与目前已上市的GLP-1R激动剂利拉鲁肽等药物相比，诺利糖肽不良反应的发生率更低。 TJ103 TJ103是创新型长效重组人源胰高血糖素样肽-1（GLP-1）Fc融合蛋白，该药物基于hyFc长效融合蛋白平台技术，分子设计具有延长GLP-1在体内的半衰期的特点，有望实现每周一次的皮下给药。格鲁塔株单抗GMA105 GMA105注射液是由鸿运华宁（杭州）生物医药有限公司自主研发的全球唯一一款具有激动GLP-1受体作用的人源化单克隆抗体。其GLP-1部分与天然人GLP-1序列相似性约为90%，可抵抗二肽基肽酶4（DPP-4）的降解，分子量大可降低肾清除，延长了半衰期，允许每周给药一次（肥胖症）或每两周给药一次（T2DM）。 GZR18 甘李药业自主研发的GZR18注射液是一种在研1类生物新药。GZR18注射液是长效胰高血糖素样肽-1（GLP-1）类似物，与人体内源性GLP-1同源性高达94%。 HEC88473 APL-18881（HEC88473）是东阳光药自主研发的Fc融合蛋白FGF21/GLP1R双重激动剂，正在针对2型糖尿病开展2期临床。该产品拟开发的适应症还包括非酒精性脂肪性肝炎、肥胖症等。 Ecnoglutide Ecnoglutide是由先为达生物开发的一种新型、长效、具有偏向性的GLP-1受体激动剂，可每周进行一次皮下注射给药。 GX-G6 GX-G6基于HyFc技术平台，在普通的Fc融合技术基础上，对Fc进行了工程化改造：融合了IgG1半衰期长、IgG4无CDC活性、IgD铰链区灵活等优势，形成了具有更长半衰期、更好安全性的杂合Fc，即HyFc。 HRS9531 HRS9531是一款靶向GLP-1R和GIPR的在研新药。GLP-1和GIP是两种天然的肠促胰素，研究表明GIP可以减少食物摄入、增加能量消耗，从而减轻体重。当GIP与GLP-1受体激动剂联合使用时，可能会对患者血糖和体重产生更大的影响。 Survodutide Survodutide是一种具有独特作用机制的胰高血糖素受体/胰高血糖素样肽-1受体（GCGR/GLP-1R）双重激动剂。Survodutide中的胰高血糖素受体激动剂组分能够增加能量消耗，并且直接对肝脏产生影响，有助于改善肝纤维化。而其GLP-1受体激动剂组分则能有效降低食欲，同时增加饱腹感。 MDR-001 MDR-001是德睿智药开发的β-arrestin 2高选择性GLP-1R激动剂。据悉，该药既保留了β-arrestin招募带来的胰岛细胞细胞修复和保护功能，又能避免β-arrestin 1招募带来的胰岛素分泌受限及介导的内吞脱敏，具有明显的差异化特性及潜在临床优势。 BGM0504 BGM0504 注射液是博瑞生物自主研发的的 GLP-1 和 GIP 受体双重激动剂，属于境内外均未上市化学药品 1 类创新药。BGM0504 注射液可激动 GIP 和 GLP-1 下游通路，产生控制血糖、减重和治疗非酒精性脂肪性肝炎（NASH）等生物学效应，拥有多种代谢疾病治疗潜力。 MWN101 MWN101注射液是一款GLP-1/GCG/GIP-Fc融合蛋白，获批适应症为拟用于2型糖尿病和肥胖治疗，该产品也是国产首款GLP-1/GCG/GIP-Fc融合蛋白，在国际研发也属于前列。 RAY1225 可通过刺激胰岛素分泌、延缓胃排空等机制调节人体代谢和控制血糖，有望用于降糖、减肥、代谢综合征等多种代谢性疾病的治疗。 VCT220 闻泰医药GLP-1R激动剂今年3月获批减肥I期临床。CDE网站显示，闻泰医药GLP-1R激动剂VCT220的I期临床试验申请获国家药监局批准，拟用于成人超重/肥胖患者的体重管理。 ZT002 ZT002是一款长效GLP-1受体激动剂，有希望实现每月仅需注射1次。此前，该产品用于成人肥胖或超重患者减重治疗，以及成人2型糖尿病患者的血糖控制的适应症均已在中国获批临床。 Orforglipron 2023年10月10日，据Insight数据库显示，礼来Orforglipron（口服GLP-1）启动国内三期临床试验ACHIEVE-1，针对二型糖尿病。ACHIEVE系列目前拥有2项临床试验，另一项针对超重2 型糖尿病患者的心血管风险。 Retatrutide Retatrutide是礼来研发的一款GLP-1/GIP/GCG三重受体激动剂，同时也是全球首款进入临床3期的GLP-1/GIP/GCG三重受体激动剂药物。利拉鲁肽注射液圣诺生物、万邦生化、先为达生物、诺博特生物纷纷布局了利拉鲁肽注射液减肥药仿制药。 CagriSema CagriSema 是一种组合疗法，由长效的 GLP - 1（胰高血糖素样肽 - 1）受体激动剂司美格鲁肽和长效的 amylin（胰淀素）类似物 cagrilintide 组成。胰淀素是与饥饿和饱腹感相关的激素，通过结合这两种成分，CagriSema 旨在提供更好的减重和降糖效果。 Supaglutide苏帕鲁肽苏帕鲁肽是一种尖端、人源化、长效GLP-1受体激动剂，目前正在积极研究治疗各种代谢性疾病，包括2 型糖尿病、肥胖症和NASH。 GSBR-1290 6月3日，硕迪生物宣布，小分子GLP-1受体激动剂GSBR-1290治疗肥胖症的IIa期研究以及胶囊和片剂PK研究均取得了积极结果。在2a阶段肥胖研究中，GSBR-1290显示出临床意义显著且统计学上显著的体重减轻效果，经安慰剂调整后，第12周平均减重6.2%（p<0.0001）。 *声明：“药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。国内首个！华东医药引进的ADC「索米妥昔单抗」获批信达「信迪利单抗」+和黄「呋喹替尼」联合疗法获批上市，治疗子宫内膜癌盘点：11月FDA批准上市的重磅药物

临床2期

2024-12-07

·药智网

全球药企市值TOP50

市值，尽管无法全面揭示一家药企内在价值，但却往往能够映射出市场对其未来发展的综合预期。 E药经理人根据choice数据统计，再次推出“全球制药企业市值TOP50”（数据截至2024年12月4日收盘），以此综合性视角来分析国内外制药企业在2024年的表现与发展态势，以及中国药企在全球制药行业中所处位置。从排名中，我们可以直观看到，与前一年相比，全球制药企业市值前十的榜单排名保持稳定，并未发生变动。不过，礼来市值整体涨幅惊人，虽今年无缘冲击万亿美元市值，但仍稳居榜首，与第二名诺和诺德的差距进一步拉大，形成明显断层。紧随其后的是强生、艾伯维、默沙东、罗氏、阿斯利康、诺华、雅培、安进。而辉瑞与赛诺菲自去年跌出前十后，仍未“回归”。相比之下，中国药企的入围名单及排名则发生了较大变化。恒瑞医药再次实现跃升，排名18，上升了2位；常在榜单中的百济神州与翰森制药上升明显，分别位居第24和第31位；同时，榜单中还出现了一位新晋面孔——百利天恒，自去年与BMS达成超600亿授权交易，刷新彼时中国创新药出海单笔交易记录后，今年以来的市值几乎稳步上升，甚至直接挺进全球药企市值前40。值得关注的一大趋势是，榜单中明星上市Biotech新晋者不在少数，如康方深度合作的Summit、Revolution Medicines、Vaxcyte等Biotech均跃进全球药企市值排名前50。这一现象背后说明，纵使一家Biotech此前名不见经传，但凭借有力的产品临床数据或重磅BD合作，便有望在资本市场上迅速获得积极反馈。图片来源：E药经理人 01 恒瑞稳居前20，百济、翰森排名跃升时隔两年，恒瑞市值再次冲回3000亿元以上。这也体现在了全球制药企业排名变化上。继去年刚刚挺进前20后，恒瑞此番再度跃升两名，冲至18名。一定程度说明，恒瑞在过去一年坚持的创新与国际化之路，受到了市场认可。首先聚焦“创新”来看。此前，业界对恒瑞最为关心的问题，莫过于“创新药营收占比何时过半”这一追问。而今年上半年的业绩，成为对这一问题的有力回答。在经历2021年、2022年业绩连续下滑后，恒瑞2023年重回正增长，2024年上半年则又迎来关键里程碑时刻，创新药收入（含税，不含对外许可收入）66.12亿元，对外许可收入1.6亿欧元，经估算，两项创新收入总和占总营收比重已过半。就创新成果角度而言，其自身免疫疾病领域首个创新药——夫那奇珠单抗注射液，已成功获批上市。就在近日，恒瑞Nectin-4 ADC创新药SHR-A2102尿路上皮癌适应症纳入拟突破性治疗品种公示。其次，聚焦“国际化”，恒瑞前不久不仅成功“带火”了中国创新药企出海的新策略——Newco模式；还传出正考虑明年赴港上市，拟募资至少20亿美元，剑指“国际化战略推进”；同时聘请了强生BD老将Jens Bitsch-Norhave担任“全球发展事务负责人”……这一系列举措，被外界视为，恒瑞又在全球市场落下重子。从综合实力整体来看，恒瑞已连续6年进入全球制药50强之列；也第三次成为全球TOP25管线规模的制药公司，并且排名已经上升至第八名；还手握超10项对外授权，海外临床的推进速度也较5年前也有了大幅提速…… 实际上，恒瑞重获市场青睐，亦可见中国创新药行业正在逐步回暖。在入围全球制药企业市值TOP50的中国药企中，恒瑞在前，百济神州紧随其后，从去年的31名跃升至24名，其次是片仔癀和翰森制药。作为国内“创新药一哥”，百济神州也交出了一份与预期相符的答卷：2024年前三季度实现营业总收入191.36亿元，同比增长48.6%，超过2023年全年营收，另第三季度营收首次突破十亿美元大关。更关键的是，百济神州在国际化征程上实现较大跨步，如BTK抑制剂泽布替尼第三季度全球销售额达49.14亿元，同比增长91.1%；PD-1替雷利珠单抗正式在美国商业化上市，还宣布开启了全球变革新阶段。纵观翰森在全球药企市值排名榜单中，从2022年的39名到2023年的38名，再到此次的31名，同样增长较为迅速。背后与其稳健发展无不相关，它几乎以Pharma的体量走出了Biotech的发展速度，从其进阶历程可见一斑：2023年营收首次突破百亿元，创新产品营收贡献超过65%；2024年上半年，营收与净利润持续高效增长，其中创新药与合作产品收入同比增长80.6%，占营收比超七成。对于这些国内大药企，何时能再有一位冲进前20，甚至诞生一家全球TOP10巨头，仍是产业界长远希冀所在。 02 百利天恒首进，一批Biotech锋芒毕露纵观“全球制药企业市值TOP50”榜单中，一大明显趋势是，“杀”进了不少Biotech。其中便有一位来自国内的明星选手——百利天恒。不少产业界人士或还记得，去年12月，百利天恒与BMS达成的总额超600亿元授权交易，一度刷新当时中国创新药出海单笔交易记录。双方合作的BL-B01D1，是全球首创且唯一进入临床阶段的靶向EGFR×HER3双抗ADC。自达成授权合作以来，百利天恒借此股价一度攀升，市值也逐渐走高。要知道，2023年1月6日，百利天恒在科创板挂牌市值仅99亿元，而今其市值已近乎翻了9倍。在全球制药企业市值排名中，百利天恒去年尚多徘徊在50名之外，今年则一举跃升至第37位，成为榜单中的国内药企“最大黑马”。当然，自授权合作后，今年围绕在百利天恒身上的里程碑事件同样不少：3月，与BMS合作的首付款已全部到账；7月，百利天恒港股IPO申请获港交所受理，欲进一步扩大百利天恒的国际化发展；9月，其BL-B01D1联合用药项目获得了FDA的1/2a期临床试验许可，用于治疗晚期实体瘤。此外，BMS与百利天恒全资子公司SystImmune紧密合作，计划于2025年启动BL-B01D1治疗实体瘤的全球注册临床研究，进一步扩大其国际应用范围……一系列事件，无一不拉高其资本市场上的表现。前不久，百利天恒董事长朱义也宣告了未来十年长远目标——扎根中国、走向世界、成为MNC。实际上，百利天恒就是这类Biotech中的一大典型代表，虽然此前名不见经传，但凭借一款新药数据或重磅合作，一旦赢得市场青睐，且不断有力数据证明，便能在资本市场上迅速获得积极反馈。与康方生物合作的Summit，同样是典例之一。自2022年底，与康方生物达成合作后，Summit市值突飞猛进。今年6月，双方再度牵手，签署了补充许可协议，在双方原有关于PD-1/VEGF双特异性抗体依沃西的合作许可协议下，拓展依沃西的许可市场范围；特别是在9月，依沃西单抗挑战K药III期研究取得积极结果，成为全球首个在单药头对头III期临床研究中证明疗效显著优于K药的药物，直接又拉动了市场一波高预期，而今挤进前40。这件事情对于产业的意义仍在上升，直接促使PD-L1/VEGF双抗成为当下“香饽饽”。继康方生物PD-1/VEGF双抗以50亿美元授权给Summit之后，普米生物PD-L1/VEGF双抗也以超10亿美元授权给BioNTech，甚至该公司随后便以9.5亿美元被后者并购；另外前不久，礼新医药的PD-1/VEGF双抗又以33亿美元授权给默沙东…… 除此之外，细看榜单中涌现的另外几位新面孔，如Insmed、Revolution、Vaxcyte等Biotech，同样如此。Revolution可是说是死磕RAS靶点，在曙光初现的数据下，股价今年实现大涨，被认为是2024年有可能被并购的中小盘股之一。Vaxcyte则凭借肺炎球菌疫苗VAX-31的1/2期数据，正挑战辉瑞Prevnar 20霸主地位，也实现了市值的跃升。未来，此类故事或将持续上演。 03 全球药企市值TOP10，格局稳定在去年的一轮激烈调整下，全球药企市值TOP10大变。一是，此前霸榜多年的市值王者强生，在2023年遇到两大“劲敌”——礼来和诺和诺德，一路凭借GLP-1，在糖尿病和减肥赛道狂奔，市值反超强生，跃居状元和榜眼，迫使强生只能退居探花位。二是，辉瑞和赛诺菲两位选手，跌出全球药企市值前十。今年，未等来反攻的故事，仍延续去年格局，排名毫无变化。凭借高涨幅，礼来市值仍是断层第一，此前甚至一度冲至9000亿美元以上，大家都在期待何时能出现一个万亿级别市值的全球制药企业。不过这一愿望只能短暂搁置，相较今年市值最高点，现已有所回落，维持在7000多亿美元。与礼来市值表现相契合的是，凭借315亿美元的前三季度营收，终于挤进了全球制药营收TOP10。诺和诺德稳居第二，在今年6月创下超6000亿美元市值高位后，而今也回落至4000亿美元出头，与去年末变化不大，不过与礼来市值差距拉大。就在近日，替尔泊肽与诺和诺德减肥产品的正面较量中，略胜一筹。数据显示，在72周时，其减重版替尔泊肽Zepbound的参与者减掉了50.3磅(22.8公斤)，而使用诺和诺德减重版司美格鲁肽Wegovy的参与者减掉了33.1磅(15公斤)。与Wegovy相比，Zepbound的减肥效果高出47%。这也就意味着，在这次单挑中，礼来替尔泊肽头对头试验击败诺和诺德司美格鲁肽。值得一提的是，今年7月，Evaluate发布最新报告，对2030年全球制药市场进行了最新预测：除非发生重大意外，否则诺和诺德和礼来有望在未来十年内稳居行业榜首。背后原因很明确，凭借GLP-1激动剂的火爆，礼来和诺和诺德不仅市值攀升至制药界巅峰，产品销售额也一再刷新记录，两家公司产品销售额均将以年均超12%的速度增长，甩开后续一众增长率低于5%的选手。另Evaluate还评选出了未来最具投资价值的十大研发项目，预计在2030年的销售额将达到近650亿美元。其中，前三甲依旧被GLP-1药物霸榜，就包括诺和诺德CagriSema，礼来口服GLP-1产品Orforglipron和Retatrutide。此外，Evaluate还重点关注了内分泌和复苏的中枢神经系统，礼来阿尔茨海默病治疗药物Donanemab榜上有名。在市值TOP10的榜单中，其余几位老面孔的市值变化不大，涨幅明显一些的当属艾伯维，但排名未变。至于这一格局何时会出现新的变动，尚值得关注。声明：本文12月5日首发于《E药经理人》（ID：eyjlr2013），经授权转载，如需二次转载请联系原作者。E药经理人媒体平台致力于成为医药行业意见领袖平台，记录和观察医药重大商业事件，展现行业的复杂与冲突，提供最前沿的思想洞见。阅读原文，是受欢迎的文章哦

抗体药物偶联物上市批准疫苗

100 项与 Orforglipron 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阻塞性睡眠呼吸暂停综合征	临床3期	美国	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	中国	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	日本	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	阿根廷	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	巴西	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	捷克	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	德国	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	印度	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	墨西哥	Eli Lilly & Co.	2024-10-22
阻塞性睡眠呼吸暂停综合征	临床3期	中国台湾	Eli Lilly & Co.	2024-10-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05051579 (EASD2023)	临床2期	超重 \| 肥胖	272	Orforglipron (OFG) 12 mg	鏇襯糧遞壓鏇製憲齋淵(積醖衊範淵積齋鹹獵艱) = 鑰構醖鬱衊醖簾齋餘窪膚網蓋膚廠齋構鹹願繭 (遞繭齋觸顧齋願觸顧獵 ) 更多	积极	2023-10-03
				Orforglipron (OFG) 24 mg	鏇襯糧遞壓鏇製憲齋淵(積醖衊範淵積齋鹹獵艱) = 製選窪鹽鬱壓願衊廠製膚網蓋膚廠齋構鹹願繭 (遞繭齋觸顧齋願觸顧獵 ) 更多
NCT05051579 (GZGI, CTgov)	临床2期	肥胖	272	LY3502970 (24 mg LY3502970)	顧簾齋鬱範鏇襯艱鬱繭(淵網膚衊鹹蓋選膚餘範) = 齋範淵鹽餘醖構鹽網顧顧範選鏇蓋醖鹽鏇壓觸 (繭醖遞鏇觸憲獵夢觸糧, 壓蓋鑰鹹糧遞糧艱窪齋 ~ 構遞積壓顧觸選齋膚顧) 更多	-	2023-09-13
				Placebo (Placebo)	顧簾齋鬱範鏇襯艱鬱繭(淵網膚衊鹹蓋選膚餘範) = 選範積齋網顧簾壓廠夢顧範選鏇蓋醖鹽鏇壓觸 (繭醖遞鏇觸憲獵夢觸糧, 夢齋膚窪簾範襯鬱製壓 ~ 選憲襯壓築鑰膚窪網網) 更多
NCT05048719 (ADA2023) 人工标引	临床2期	2型糖尿病	383	Orforglipron 3 mg	廠膚蓋鑰簾簾醖願醖鏇(襯築鹹簾網餘鹽積製鹽) = 願壓廠繭願艱願製鏇製鬱廠鹹製壓獵壓艱範鬱 (艱艱襯獵餘顧糧蓋範願 ) 更多	积极	2023-06-25
				Orforglipron 12 mg	廠膚蓋鑰簾簾醖願醖鏇(襯築鹹簾網餘鹽積製鹽) = 鏇壓襯鹹膚鹹淵製鏇製鬱廠鹹製壓獵壓艱範鬱 (艱艱襯獵餘顧糧蓋範願 ) 更多
NCT05048719 (Literature) 人工标引	临床2期	2型糖尿病	303	orforglipron	艱窪壓鏇鬱獵鏇窪壓網(膚蓋觸顧廠憲蓋衊顧網) = 顧遞鏇廠築齋遞範淵鏇鹽蓋簾遞製繭膚淵網鏇 (憲淵構選鏇齋鹹鑰夢壓 ) 更多	积极	2023-06-23
				Dulaglutide	艱窪壓鏇鬱獵鏇窪壓網(膚蓋觸顧廠憲蓋衊顧網) = 遞廠衊鑰選鹽艱襯窪網鹽蓋簾遞製繭膚淵網鏇 (憲淵構選鏇齋鹹鑰夢壓 ) 更多
NCT05051579 (ADA2023) 人工标引	临床2期	超重 \| 肥胖	272	Orforglipron 12 mg	齋艱齋觸製艱醖蓋夢構(膚憲餘網網淵襯膚選顧) = 簾夢壓繭衊鑰觸遞繭構積鬱遞繭夢壓構遞鬱憲 (齋艱艱鬱鬱鏇壓鏇齋醖 ) 更多	积极	2023-06-23
				Orforglipron 24 mg	齋艱齋觸製艱醖蓋夢構(膚憲餘網網淵襯膚選顧) = 齋獵鬱糧壓餘範夢鑰積積鬱遞繭夢壓構遞鬱憲 (齋艱艱鬱鬱鏇壓鏇齋醖 ) 更多
NCT05051579 (GZGI, Pubmed)	临床2期	肥胖	272	Orforglipron 12 mg	(醖夢觸願網壓簾餘築獵) = 衊鏇淵築衊築窪簾廠餘壓遞窪獵選窪廠齋鑰壓 (齋餘繭夢蓋顧鏇鹹衊網 )	-	2023-06-23
				Orforglipron 24 mg	(醖夢觸願網壓簾餘築獵) = 簾製夢選膚齋壓壓築構壓遞窪獵選窪廠齋鑰壓 (齋餘繭夢蓋顧鏇鹹衊網 )
ADA2023 人工标引	临床1期	-	46	Orforglipron 3mg (fasted)	襯窪齋蓋蓋襯齋顧壓遞(憲壓齋觸鑰壓遞遞鹹網) = 衊鹽選廠壓構鹽鹹憲憲壓鏇築膚艱構艱艱積膚 (鑰膚艱觸餘廠鬱鏇構網 ) 更多	积极	2023-06-20
				Orforglipron 3mg (fed)	襯窪齋蓋蓋襯齋顧壓遞(憲壓齋觸鑰壓遞遞鹹網) = 衊鹹顧衊獵製鹹膚觸壓壓鏇築膚艱構艱艱積膚 (鑰膚艱觸餘廠鬱鏇構網 ) 更多
NCT04426474 (NEWS) 人工标引	临床1期	2型糖尿病	68	LY3502970	夢衊鑰遞鏇窪艱網鹹窪(鑰襯淵廠鹽獵膚壓憲廠) = 鬱積選窪衊淵構鑰窪觸憲壓淵獵顧範觸繭鹽遞 (鬱觸壓壓築窪膚構製蓋 ) 更多	积极	2022-10-13
				Placebo	壓憲襯獵鹹製製餘鹹餘(襯製淵鏇壓襯構艱鑰膚) = 積鑰憲窪鹹構鏇廠鹹襯網遞廠選觸簾築糧積築 (糧鹽襯壓壓遞醖鏇齋製 ) 更多
NCT04426474 (EASD2022)	临床1期	2型糖尿病 HbA1c	51	LY3502970	廠選醖衊遞遞糧顧膚蓋(願積淵築淵艱鹽窪艱艱) = One patient reported 2 severe gastrointestinal events (1 each of nausea and vomiting); all other events were mild or moderate 憲選製窪範膚壓衊衊簾 (淵膚夢廠顧選廠鏇餘鏇 )	积极	2022-09-20
				Placebo
NCT03929744 (ADA2022)	临床1期	-	133	LY3502970	鹹夢構壓壓鹽蓋築廠窪(獵蓋淵蓋夢廠積鬱遞簾) = occurring in ≥3 subjects 鹹窪糧鏇簾窪蓋顧選壓 (壓鹽繭醖網壓糧觸窪製 ) 更多	-	2022-06-01