Retatrutide

Eli Lilly plans to use its massive pipeline power to test its incretin therapies in neuroscience and immunology fields.\n Eli Lilly has invested heavily into obesity, dominating the landscape—alongside semaglutide maker Novo Nordisk—with its blockbuster molecule tirzepatide. Now, with a pipeline chock-full of numerous incretin therapies, the Big Pharma\'s new strategy will be to test some of those drugs across neurology and immunology indications.\"A new focus area first in 2025 will be to study potential new applications of incretin biology across diseases in neuroscience and immunology,” Lilly’s chief scientific officer Daniel Skovronsky, M.D., Ph.D., said during a Feb. 6 investor call. “With a pipeline of incretins in clinical development and deep scientific expertise in this space, Lilly is well positioned to match the biologic properties of specific molecules to the desired indications being studied.”The pharma plans to launch several clinical trials “assessing potential benefits” of Lilly’s existing incretins across areas that “could include brain health, substance use disorder, pain, neuropsychiatry and inflammation,” Skovronsky explained.“We\'ll be prepared to move rapidly into phase 3 trials based on clinical data and where our conviction is high,” the CSO added. Lilly has invested billions into manufacturing capabilities to support the launch of obesity drug Zepbound and other phase 3 assets in cardiometabolic diseases, Patrik Jonsson, chief customer officer and president of diabetes and obesity, said last summer.This massive investment and established infrastructure could now be used to support the company\'s potential expansion into other therapeutic landscapes.The company did not elaborate further on what incretin drugs it plans to test.A look at some of Lilly’s incretin therapies  Incretins are hormones that are released after eating, affecting the body’s insulin response.Eli Lilly\'s approved incretin therapy is tirzepatide, an injectable dual GLP-1 and GIP receptor sold as Mounjaro for diabetes and Zepbound for weight loss and, most recently, obstructive sleep apnea. Tirzepatide is currently awaiting an FDA decision for use in heart failure preserved ejection fraction, as well.The company also boasts the clinical-stage prospect retatrutide, a triple-hormone-receptor agonist that targets GLP-1, GIP and glucagon. In a phase 2 trial obesity trial, the investigational candidate was tied to a 24% mean reduction in weight, or the equivalent of 58 pounds, after 48 weeks.After seeing the data, Lilly pressed the gas, entering retatrutide into a phase 3 program—dubbed TRIUMPH—that is testing the candidate out in chronic weight management, obstructive sleep apnea and knee osteoarthritis among people with obesity and who are overweight.The pharma giant expects top-line readouts for both the obesity and osteoarthritis trials sometime this year, according to the company’s quarterly presentation Thursday. Lilly had previously said data were anticipated in early 2026.   “We believe this potential new medicine can deliver even more weight loss than tirzepatide and could potentially provide additional health benefits,” Skovronsky said on the investor call. Furthermore, the company houses orforglipron, an investigational daily oral nonpeptide GLP-1 receptor agonist being tested in late-stage trials for obesity and obstructive sleep apnea. Lilly also plans to launch a phase 3 study for the candidate in hypertension this year. “I’m excited that this year we\'re looking forward to reading out multiple orforglipron trials,\" Skovronsky said. \"We expect to see data from up to five studies in Type 2 diabetes and two studies in obesity. Our goal is to generate [an] efficacy, safety and tolerability profile that is similar to that of an injectable, single-acting GLP-1, but through an orally available medicine.”

双双逼近300亿美元 2月4日，默沙东公布2024年财报，总营收达641.68亿美元，同比增长7%。默沙东制药业务收入574.00亿美元，同比增长7%。2023年的药王Keytruda（帕博利珠单抗）营收高达294.82亿美元，同比增长18%，其销售额约占默沙东全年总营收的46%，成功卫冕2024年的全球药王。 图：默沙东财报 2月5日，诺和诺德公布了2024年度财务报告。2024年，诺和诺德全球销售额为 2904亿丹麦克朗，约合421.49 亿美元。其中，超级重磅产品司美格鲁肽大卖 292.96亿美元，占到了诺和诺德总营收的约69.5%。具体来看，Ozempic （降糖注射版）销售额为1203.42 亿丹麦克朗，约为 174.66亿美元（+26%）；Rybelsus（降糖口服版）销售额约为33.82亿美元（+26%）；Wegovy（减重版）销售额约为 84.48亿美元（+86%）。 图：诺和诺德财报 在2024年上半年药企公布的财报中，司美格鲁肽和K药的销售额差距为12亿美元，而在年底最新的财报中，这一差距几乎被追平，两款药物2024年全年销售额仅仅相差1.86亿美元，以此增速，2025年的药王似乎已是司美格鲁肽的囊中之物。 司美格鲁肽的三款产品中，Wegovy带来了核心增长动力，增幅高达87%，诺和诺德CEO拉尔斯·弗鲁尔高·约根森（Lars Fruergaard Jørgensen）表示，目前公司在美国已覆盖了约200万名肥胖患者，而美国肥胖人群总数约为5500万，因此Wegovy未来仍有较大的市场潜力。诺和诺德还推出了高剂量7.2mg的Wegovy，尽管最新临床结果未达到市场预期。 司美格鲁肽一直面临产能不足问题，而高剂量的产品对产能也提出了更高的要求，诺和诺德也一直在买厂建厂、扩增产能。2024年12月份，诺和诺德宣布成功收购CDMO巨头Catalent，GLP-1产品的产能不足问题有望于今年得到缓解。为了推动Wegovy的进一步增长，诺和诺德计划2025年在生产方面投入650亿丹麦克朗，而去年为450亿丹麦克朗。这一支出将用于三家新收购的Catalent工厂的全面投产。 不断拓展新适应症 诺和诺德一直在积极拓宽司美格鲁肽的多项适应症，其中一些与糖尿病和肥胖相关的并发症有关。除了心血管疾病外，还包括慢性肾病、心力衰竭、非酒精性脂肪性肝炎等。此外，司美格鲁肽还在探索阿尔茨海默病、缺血性脑卒中、帕金森病和外周动脉疾病等新的适应症领域。 图：司美格鲁肽全球在研适应症所处阶段 来源：Pharma ONE药物研发数据库 推出联合疗法&新产品 不仅如此，诺和诺德也不断推出新产品，以捍卫企业在降糖减重领域的核心地位。 ● CagriSema： CagriSema是由诺和诺德公司研发的一种新型固定剂量联合疗法，主要用于治疗肥胖症和2型糖尿病，由长效胰淀素类似物cagrilintide和GLP-1受体激动剂司美格鲁肽组成，两种药物的剂量均为2.4mg。其中，司美格鲁肽通过刺激胰岛素分泌、抑制胰高血糖素分泌，减缓胃排空，降低食欲和食物摄入量；长效胰淀素类似物（cagrilintide）通过减缓肠道葡萄糖吸收和减少餐后肝糖释放，增加饱腹感，减少食物摄入。然而，在近期诺和诺德最新公布的临床3期试验REDEFINE 1的主要结果中，CagriSema的患者在68周后平均减轻了22.7%的体重，低于此前公司25%的预期水平，导致了诺和诺德股价的下跌。 ● Amycretin： Amycretin是一款诺和诺德开发的GLP-1/胰淀素双靶点激动剂，诺和诺德同时还开发了该产品的皮下剂型NN9490和口服剂型NN9487。2025年1月24日，诺和诺德公布Amycretin治疗肥胖的1b/2a期临床最新数据，1.25mg、5mg、20mg剂量组治疗36周分别减重9.7%、16.2%、22.0%，安慰剂组减重2.0%左右，安慰剂校正后，20mg高剂量组治疗36周减重幅度达到20.0%。该结果带动诺和诺德股价大幅上涨8%，Amycretin有望超越礼来的替尔泊肽和Retatrutide。 图：Amycretin简介 危机意识 销售额大涨的背后也暗藏危机，司美格鲁肽在中国的核心序列专利将于2026年3月到期，势必会有一大批生物类似药上市，抢夺这一巨大的市场份额，据Pharma ONE药物研发数据库统计，截至目前，已有近20家企业的司美格鲁肽生物类似药加入战局，其中丽珠医药、杭州九源、珠海联邦的产品均已处于注册申请阶段。 表：司美格鲁肽生物类似药竞争格局 来源：Pharma ONE药物研发数据库 END  如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001