Levothyroxine Sodium

药械追踪No.1 / 四环医药CDK4/6抑制剂吡洛西利在华获批，治疗HR+/HER2-乳腺癌2025年5月16日，四环医药（0460.HK）宣布，非全资附属公司轩竹生物自主研发的1类创新药吡洛西利片（商品名：轩悦宁）已获得中国国家药监局（NMPA）批准，适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性晚期或转移性乳腺癌成人患者：①与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的患者；②单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者。吡洛西利是国内唯一获批单药用于HR+/HER2-晚期乳腺癌后线治疗的CDK4/6抑制剂，也是轩竹生物首个获批上市的抗肿瘤创新药。临床研究显示，接受吡洛西利联合氟维司群二线治疗的患者中位无进展生存期（mPFS）经研究者评估达14.7个月，经盲态独立评审委员会（BIRC）评估达17.5个月。接受吡洛西利单药后线治疗的患者mPFS长达11个月，刷新全球同类疗法纪录。->点击文末阅读原文，解锁完整双语新闻No.2 / 默沙东HIF-2α抑制剂贝组替凡获FDA批准PPGL新适应证2025年5月16日，默沙东宣布，贝组替凡（商品名：维利瑞/WELIREG）已获美国食品药品监督管理局（FDA）批准新适应证，用于治疗局部晚期、不可切除或转移性的嗜铬细胞瘤或副神经节瘤（PPGL）成人和12岁及以上儿科患者。贝组替凡是一款HIF-2α（低氧诱导因子2α）抑制剂；HIF-2α在多种肿瘤类型中高表达，可在低氧状态下促进肿瘤细胞的增殖与存活。FDA此前已批准贝组替凡用于von Hippel-Lindau（VHL）病相关肾细胞癌（RCC）、中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET），以及既往接受过PD-1/PD-L1抑制剂和VEGF靶向疗法治疗的晚期RCC。PPGL是源自同一组织的罕见肿瘤，可能由某些遗传综合征或基因突变引起；其中嗜铬细胞瘤形成于肾上腺，副神经节瘤则形成于肾上腺外组织。单臂LITESPARK-015研究支持了贝组替凡PPGL新适应证的获批。该研究纳入了72例患者，结果显示每日一次120 mg剂量的贝组替凡治疗达到了客观缓解率（ORR）主要终点。此外，基于临床研究中的安全性风险，FDA予以贝组替凡黑框警告，提示妊娠期间使用贝组替凡可能导致胚胎-胎儿损害，还可能使某些激素避孕药失效；在开始用药前需确认妊娠状态，并向患者告知这些风险以及使用有效非激素避孕方法的必要性。贝组替凡还可能导致严重贫血，可能需要输血治疗；在使用贝组替凡前及治疗期间需定期监测贫血情况。贝组替凡可能引发严重低氧血症，可能需要停药、补氧或住院治疗。->点击文末阅读原文，解锁完整双语新闻No.3 / 北海康成戈谢病1类新药维拉苷酶β在华获批上市2025年5月16日，北海康成（1228.HK）宣布，旗下注射用维拉苷酶β（商品名：戈芮宁）获国家药监局批准上市。戈芮宁是国内首个本土自主研发适用于12岁及以上青少年和成人Ⅰ型和Ⅲ型戈谢病患者的长期酶替代治疗，属1类创新药并可完全替代同类进口产品。大多数戈谢病患者为Ⅰ型和Ⅲ型，分别为慢性非神经病变型和慢性神经病变型。维拉苷酶β通过静脉输注特异性地补充戈谢病患者体内溶酶体中缺乏的葡萄糖脑苷脂酶。维拉苷酶β的关键性临床试验于2024年8月取得积极顶线数据，该研究在60U/kg剂量组（P<0.0001）和较低的30U/kg剂量组（P<0.001）都成功达到了其主要疗效终点，即治疗9个月后受试者脾脏体积较基线的平均缩小百分比。->点击文末阅读原文，解锁完整双语新闻No.4 / 海思科镇痛药安瑞克芬在华获批上市2025年5月15日，海思科（002653.SZ）宣布，旗下安瑞克芬获国家药监局批准上市，用于治疗腹部手术后的轻、中度疼痛。安瑞克芬（HSK21542）是公司自主研发的强效外周kappa阿片受体（KOR）选择性激动剂，其具有高选择性和亲和性，在G蛋白参与下协同调控钾离子流和钙离子流，可阻断疼痛和瘙痒信号传导，并通过抑制背根神经节和末梢感觉神经的兴奋性，减少炎性因子以及神经递质的释放，起到镇痛和抑制瘙痒的作用。本品不透过血脑屏障，在发挥外周镇痛、止痒药效的同时，能避免中枢阿片类药物相关副作用，如致幻、成瘾、呼吸抑制等。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 13亿美元！礼来与韩国Rznomics达成RNA编辑疗法全球合作2025年5月15日，韩国生物制药公司Rznomics Inc.宣布与礼来签署了一项战略性的全球研发合作与许可协议，礼来将利用Rznomics专有的转录剪接核糖酶平台开发和商业化新型RNA编辑疗法。此次合作专注于发现和开发用于感音神经性耳聋的RNA编辑疗法。Rznomics将根据双方共同批准的研究计划开展早期研究，而礼来公司将负责后续的开发和商业化。如果礼来公司行使协议中所有可用的选项，交易总价值可能超过13亿美元，此外还将包括产品销售的单独特许权使用费。Rznomics是一家总部位于韩国的临床阶段生物制药公司，专注于开发基于RNA的基因疗法。该公司的专有转录剪接核糖酶平台能够实现精准的RNA编辑，并在多种适应证中具有广泛的应用潜力。->点击文末阅读原文，解锁完整双语新闻No.2 / 默克2025Q1财报：医疗领域收入增长3.4%2025年5月15日，德国默克发布2025年第一季度财务业绩。集团收入53亿欧元，同比有机增长2.5%。其中医疗保健领域收入21亿欧元，同比有机增长3.4%，息税折旧摊销前利润（EBITDA）预估增长11.7%，达到7.96亿欧元。这主要得益于研发支出的暂时减少。该业务领域的心血管、代谢和内分泌学产品组合是主要增长驱动力，所有治疗领域的销售额均实现有机增长。该产品组合的净销售额有机增长10.6%，达到7.57亿欧元。按治疗领域划分，肿瘤业务收入4.91亿欧元（-1.9%），其中爱必妥（西妥昔单抗）销售额3.05亿欧元（+6.2%），Bavencio（阿维鲁单抗）销售额1.57亿欧元（-15.4%）；神经免疫业务收入4.07亿欧元（-3.7%），其中Mavenclad（克拉屈滨）销售额2.87亿欧元（+9.2%），Rebif（重组人干扰素β1a）销售额1.2亿欧元（-25.1%）；生殖领域收入3.82亿欧元（-0.4%），其中果纳芬（重组人促卵泡激素）销售额2.06亿欧元（+0.3%），Pergoveris（促卵泡素α促黄体激素α）销售额7800万欧元（+13.6%）；心血管、代谢和内分泌领域收入7.57亿欧元（+10.6%），其中格华止（二甲双胍）销售额2.42亿欧元（+10.4%），康忻（比索洛尔）销售额1.57亿欧元（+12.2%），优甲乐（左甲状腺素）销售额1.55亿欧元（+12.7%），Saizen（重组人生长激素）销售额1.03亿欧元（+18.6%）。默克根据当前宏观经济和地缘政治环境的影响，对其2025年全年的集团指导目标进行了小幅调整，也与当前关税的不确定性有关。集团预计2025年收入209~224亿欧元，有机增长2%~6%，其中医疗保健领域预计全年收入83~89亿欧元，有机增长2%~6%。在关税影响下，5月11日，默克要求自5月12日起对所有发往中国的产品订单加收临时附加费（生命科学）。但一天后，该临时附加费停止实施。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

Endo's products are the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed intravenous (IV) bag MALVERN, Pa., May 15, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of ADRENALIN® (epinephrine in 0.9% sodium chloride injection) 8 mg/250 mL premixed bag and will begin shipping the product the week of May 19, 2025. ADRENALIN® is the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed IV bag. "Hospital pharmacists and healthcare providers are working harder than ever, and we are committed to supporting them with ready-to-use medicines that help reduce complexity and streamline operations so they can focus on what matters most—patient care," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics. "With this new ADRENALIN® premixed bag concentration, plus the additional concentrations in our pipeline, we are proud to offer options and choice through our TruDelivery® portfolio." Key product benefits include: No compounding or preparation required Single-port IV tubing to reduce the risk of inadvertent mixture 24-month shelf life at room temperature The ADRENALIN® premixed bag is part of Endo Injectable Solutions' TruDelivery® product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care. In addition to the new 8 mg/250 mL bag, Endo offers ADRENALIN® 4 mg/250 mL premixed bag and plans to launch 5 mg/250 mL and 10 mg/250 mL concentrations. The company also offers ADRENALIN® (epinephrine injection, USP) 1 mL single-dose and 30 mL multi-dose vials. ADRENALIN® is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. DRUG INTERACTIONS: Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Click for Full Prescribing Information. About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product shipments, commercial availability, product benefits, reduction of waste, costs and errors, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and Form 10-Q. SOURCE Endo, Inc. 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