A pilot single-centre double-blind randomised controlled trial of centhaquine in the treatment of vasodilatory hypotension in adults admitted to the intensive care unit

开始日期2024-10-07

申办/合作机构

Austin Health

NCT05241067

/ Not yet recruiting临床2期

A Multicentric Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Centhaquine as an Adjuvant to the Standard of Care in COVID-19 Patients With Moderate to Severe Acute Respiratory Distress Syndrome

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus causing coronavirus disease 2019 (COVID-19), which has been a global pandemic since March 2020. According to WHO, more than 289 million cases have been confirmed worldwide, with just over 5.4 million reported deaths as of January 2022. SARS-CoV-2 variants continue to emerge, with the omicron variant causing the increased surge in cases. Currently, Johns Hopkins University of Medicine reports a case fatality rate of 1.5% for the United States. COVID-19 infections may be asymptomatic in some cases, while most cases cause mild to moderate illness with respiratory and flu-like symptoms. However, a significant number of COVID-19 cases develop severe life-threatening illness involving severe pneumonia and acute respiratory distress syndrome (ARDS), requiring admission to the intensive care unit (ICU)
Although there have been breakthroughs in the treatment for COVID-19, most of these are directed at mild-to-moderate disease rather than patients with severe disease on mechanical ventilators. There is still a need for novel and effective treatment options in severe COVID-19 illness with continued vaccine hesitancy, decreased social distancing, and new emerging variants.
Centhaquine is a first-in-class resuscitative agent for the hypovolemic shock that is approved for marketing in India. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647). Clinical phase II (CTRI/2017/03/008184) and phase III (CTRI/2019/01/017196) results indicate that centhaquine is a novel first-in-class, highly effective resuscitative agent for hypovolemic shock. Centhaquine provided hemodynamic stability and significantly improved acute respiratory distress syndrome (ARDS) and multiple organ dysfunction score (MODS) in clinical trials conducted in India. A total of 155 patients with hypovolemic shock have been studied (combined phase II and III). Centhaquine is safe and reduced the mortality from 10.71% in patients receiving standard treatment to 2.20% in patients that received centhaquine (odds ratio 5.340; 95% CI 1.270-26.50; P=0.0271). In a phase 3 study of hypovolemic shock, ARDS and MODS were secondary endpoints, and centhaquine reduced both with a significant p-value.

开始日期2024-03-31

申办/合作机构

Pharmazz, Inc.

CTRI/2023/12/060444

/ Completed临床2/3期

A randomized, double-blind, placebo-controlled pilot study to evaluate the effect of centhaquine on cardiovascular parameters in patients with hypovolemic shock. - NIL

开始日期2023-12-15

申办/合作机构-

100 项与 Centhaquine Citrate 相关的临床结果

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100 项与 Centhaquine Citrate 相关的转化医学

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100 项与 Centhaquine Citrate 相关的专利（医药）

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项与 Centhaquine Citrate 相关的文献（医药）

2024-07-01·CNS & Neurological Disorders - Drug Targets

Evolutionary Unmasking Resuscitative Therapeutics Potential of Centhaquin Citrate in Hypovolemic Shock

Review

作者: Khan, Heena ; Oberoi, Muskaan ; Singh, Varinder ; Singh, Thakur Gurjeet ; Singh, Ravinder ; Aggarwal, Namita ; Kumari, Pratima

Abstract:Hypovolemic shock (HS), a clinical condition of insufficient blood perfusion and oxygenation in body tissues, is associated with immense morbidity and mortality. Treatment approaches include fluid replacement and surgical repair of reversible causes of hemorrhage; however, they cause irreversible blood perfusion loss, systemic inflammation, multiple organ failure, and death. Centhaquin citrate (CC) is an innovative centrally acting cardiovascular active agent that is initially intended as an antihypertensive drug. However, due to its positive ionotropic effect, Centhaquin citrate is being tested clinically as a resuscitative agent for the management of hypovolemic shock It acts at the α2B-adrenergic receptor to produce venous constriction followed by an increase in venous return to the heart. These actions are assumed to be capable of resuscitative activity observed by centhaquin citrate, through an increase in cardiac output and tissue perfusion. Pharmacokinetics investigations in animals and humans have shown that centhaquin citrate is well tolerated and has insignificant side effects. Therefore, centhaquin citrate seems to be a promising entity and gaining the interest of researchers to develop it as a resuscitative agent in HS. The review gives insight into the development of centhaquin citrate as a resuscitative agent and provides insight into the associated mechanism of action and molecular signalling to foster future research on CC for its clinical use in HS.

2021-06-01·Drugs1区 · 医学

A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin®) as a Resuscitative Agent in Hypovolemic Shock Patients

1区 · 医学

Article

作者: Bothra, Aditya R ; Jeswani, Deepak ; Ali, S K Noushad ; Gulati, Anil ; Singh, Saurabh ; Maheshwari, Sanjiv ; Singh, Gyan P ; Haveri, Sameer ; Choudhuri, Rajat ; Gupta, Ajay ; Agrawal, Nilesh Radheshyam ; Sidhu, Gursaran Kaur ; Haque, Parvez David ; Agarwal, Apurva ; Rahate, Prashant

INTRODUCTIONCenthaquine (Lyfaquin^®) showed significant safety and efficacy in preclinical and clinical phase I and II studies.METHODSA prospective, multicentric, randomized phase III study was conducted in patients with hypovolemic shock, systolic blood pressure (SBP) ≤ 90 mmHg, and blood lactate levels ≥ 2 mmol/L. Patients were randomized in a 2:1 ratio to the centhaquine group (n = 71) or the control (saline) group (n = 34). Every patient received standard of care (SOC) and was followed for 28 days. The study drug (normal saline or centhaquine 0.01 mg/kg) was administered in 100 mL of normal saline infusion over 1 h. The primary objectives were to determine changes (mean through 48 h) in SBP, diastolic blood pressure (DBP), blood lactate levels, and base deficit. The secondary objectives included the amount of fluids, blood products, and vasopressors administered in the first 48 h, duration of hospital stay, time in intensive care units, time on ventilator support, change in acute respiratory distress syndrome (ARDS), multiple organ dysfunction syndrome (MODS), and the proportion of patients with 28-day all-cause mortality.RESULTSThe demographics of patients and baseline vitals in both groups were comparable. The cause of hypovolemic shock was trauma in 29.4 and 47.1% of control group and centhaquine group patients, respectively, and gastroenteritis in 44.1 and 29.4%, respectively. Shock index (SI) and quick sequential organ failure assessment at baseline were similar in the two groups. An equal amount of fluids and blood products were administered in both groups during the first 48 h of resuscitation. A lesser amount of vasopressors was needed in the first 48 h of resuscitation in the centhaquine group. An increase in SBP from baseline was consistently higher up to 48 h (12.9% increase in area under the curve from 0 to 48 h [AUC_0-48]) in the centhaquine group than in the control group. A significant increase in pulse pressure (48.1% increase in AUC_0-48) in the centhaquine group compared with the control group suggests improved stroke volume due to centhaquine. The SI was significantly lower in the centhaquine group from 1 h (p = 0.032) to 4 h (p = 0.049) of resuscitation. Resuscitation with centhaquine resulted in a significantly greater number of patients with improved blood lactate (control 46.9%; centhaquine 69.3%; p = 0.03) and the base deficit (control 43.7%; centhaquine 69.8%; p = 0.01) than in the control group. ARDS and MODS improved with centhaquine, and an 8.8% absolute reduction in 28-day all-cause mortality was observed in the centhaquine group.CONCLUSIONCenthaquine is an efficacious resuscitative agent for treating hypovolemic shock. The efficacy of centhaquine in distributive shock is being explored.TRIAL REGISTRATIONClinical Trials Registry, India; ctri.icmr.org.in, CTRI/2019/01/017196; clinicaltrials.gov, NCT04045327.

2021-06-01·Advances in Therapy3区 · 医学

Resuscitative Effect of Centhaquine (Lyfaquin®) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial

3区 · 医学

Article

作者: Das, Soumen ; Gulati, Anil ; Agrawal, Nilesh Radheshyam ; Lavhale, Manish S ; Rahate, Prashant ; Jain, Dinesh ; Dhibar, Deba Prasad ; Haveri, Sameer ; Choudhuri, Rajat ; Agarwal, Rohit ; Prabhu, Madhav

INTRODUCTIONCenthaquine (Lyfaquin^®) showed significant efficacy as a resuscitative agent in animal models of haemorrhagic shock. Its safety and tolerability were confirmed in healthy human volunteers. In this study, our primary objective was to determine the safety, and the secondary objective was to assess the efficacy of centhaquine in patients with hypovolemic shock.METHODSA prospective, multicentre, randomized phase II study was conducted in male and female patients aged 18-70 years with hypovolemic shock having systolic BP ≤ 90 mmHg. Patients were randomized in a 1:1 ratio to either the control or centhaquine group. The control group received 100 ml of normal saline infusion over 1 h, while the centhaquine group received 0.01 mg/kg of centhaquine in 100 ml normal saline infusion over 1 h. Every patient received standard of care (SOC) and was followed for 28 days.RESULTSFifty patients were included, and 45 completed the trial: 22 in the control group and 23 in the centhaquine group. The demographics of patients in both groups were comparable. No adverse event related to centhaquine was recorded in the 28-day observation period. The baseline, Injury Scoring System score, haemoglobin, and haematocrit were similar in both groups. However, 91% of the patients in the centhaquine group needed major surgery, whereas only 68% in the control group (p = 0.0526). Twenty-eight-day all-cause mortality was 0/23 in the centhaquine group and 2/22 in the control group. The percent time in ICU and ventilator support was less in the centhaquine group than in the control group. The total amount of vasopressors needed in the first 48 h of resuscitation was lower in the centhaquine group than in the control group (3.12 ± 2.18 vs. 9.39 ± 4.28 mg). An increase in systolic and diastolic BP from baseline through 48 h was more marked in the centhaquine group than in the control group. Compared with the control group, blood lactate level was lower by 1.75 ± 1.07 mmol/l in the centhaquine group on day 3 of resuscitation. Improvements in base deficit, multiple organ dysfunction syndrome (MODS) score and adult respiratory distress syndrome (ARDS) were greater in the centhaquine group than in the control group.CONCLUSIONWhen added to SOC, centhaquine is a well-tolerated and effective resuscitative agent. It improves the clinical outcome of patients with hypovolemic shock.TRIAL REGISTRATIONClinicalTrials.gov identifier number: NCT04056065.

项与 Centhaquine Citrate 相关的新闻（医药）

2024-08-26

·医药观澜

10家创新药公司完成新一轮融资，1家来自中国

▎药明康德内容团队报道根据即刻药数数据库，上周（8月19日~8月25日）全球生物制药领域至少10家致力于创新药研发的公司宣布完成新一轮融资，其中包括1家中国公司。这些获得融资的新锐主要致力于开发小分子药物、RNA疗法、线粒体疗法、癌症免疫疗法等，涉及肾病、肥胖和代谢，心血管以及癌症等治疗领域。 Borealis Biosciences 轮次：A轮金额：1.5亿美元 8月22日，Borealis Biosciences宣布走出隐匿模式并获得创始投资者Versant Ventures和诺华（Novartis）合计1.5亿美元的A轮融资。该公司也与诺华达成战略研究合作，共同开发用于治疗肾脏疾病的RNA疗法。 Borealis旨在通过开发RNA疗法促进科学和转化上的突破，以满足肾病患者的主要未满足需求。该公司的目标包括更好地了解患者分层、遗传学定义的治疗靶标，并致力将治疗有效载荷递送到特定肾细胞类型，以及推进RNA化学的进展。此次诺华参与了Borealis的A轮融资，并承诺提供高达1亿美元的前期和短期研究资金。作为协议的一部分，诺华将有权从Borealis收购两个未来的潜在开发项目，Borealis则有资格在达到临床和监管等里程碑后获得总额达7.5亿美元款项。 Ambrosia Biosciences 轮次：A轮金额：1600万美元 8月21日，Ambrosia Biosciences宣布成功完成A轮融资。本次融资总额为1600万美元，由BVF Partners和Boulder Ventures领投。Ambrosia将利用这笔融资扩大其药物发现项目和实验室运营。 Ambrosia Biosciences专注于发现和开发针对GLP-1受体及其他B类G蛋白偶联受体的全新口服小分子疗法。该公司的研发团队来自原Array BioPharma的药物化学团队。在Array BioPharma被辉瑞收购后，这一团队再度启程，在Ambrosia公司将利用在小分子药物发现方面的专长，开发治疗肥胖症和代谢疾病的药物。 Retension Pharmaceuticals 轮次：A轮金额：1040万美元 8月21日，Retension Pharmaceuticals宣布完成A轮1040万美元融资。Retension是一家临床阶段生物医药公司，专注于开发针对高血压和心血管疾病的创新疗法。该公司的主要候选药物RTN-001是在赛诺菲的全球独家许可下开发，为一款第二代PDE5抑制剂。与早期用于勃起功能障碍的PDE5抑制剂不同，该产品被设计优先分布于心血管组织，从而有望克服第一代PDE5抑制剂在高血压领域的局限性。在此前包括265多名受试者的多项临床试验中，该药耐受性良好，显示出对难治性高血压患者的疗效。根据新闻稿，本轮融资将用于启动RTN-001的一项2期临床研究，针对服用两种或两种以上抗高血压药物仍不受控制的高血压患者。 Pharmazz 轮次：战略投资金额：1500万美元 8月21日，Pharmazz公司宣布和Sun Pharma签署一项协议，Sun Pharma将向Pharmazz投资约1500万美元，支持其完成sovateltide治疗急性脑缺血患者的关键3期研究。同时双方将扩大此前签署的许可协议，Sun Pharma将拥有sovateltide在印度以及其他新兴国家的商业化权利。Sovateltide是一种高选择性内皮素B受体激动剂，可增加血流量，显示抗凋亡活性，保护神经线粒体，促进神经血管重塑。 Pharmazz公司专注于发现、收购、开发和商业化针对重症监护医学的治疗方法，产品类型包括肽和其他小分子药物。该公司正在开发三种针对多种重症监护适应症的新型药品，主要产品centhaquine用于治疗低血容量性休克，第二种化合物Sovateltide用于治疗脑缺血性中风、阿尔茨海默病和其他神经退行性疾病。第三种化合物正在开发中，用于治疗糖尿病酮症酸中毒和消除阿片类药物耐受。 Pathalys Pharma 轮次：B轮金额：1.05亿美元 8月20日，专注于肾病疗法研发的Pathalys Pharma宣布完成1.05亿美元的B轮融资，用于完成两项正在进行的临床试验，向美国FDA申报NDA以及加快批准前的商业化准备。该轮超额融资由TCGX牵头，其他投资者也加入其中，包括JP Morgan Life Sciences Private Capital、Samsara BioCapital、Marshall Wace、KB Investment、JPS Growth Investment Limited Partnership，以及得到了创始投资方Catalys Pacific和DaVita Venture Group的支持。 Pathalys专注的重点领域之一是改进继发性甲状旁腺功能亢进症（SHPT）的治疗。该公司在研疗法upacicalcet是一种新型拟钙剂（calcimimetic）。拟钙剂是一种通过激活钙敏感受体来模仿钙在组织上作用的药物，常用于治疗继发性SHPT。Upacicalcet可在透析结束时通过预填充注射器进行静脉注射。研究表明，它能有效降低甲状旁腺激素水平，并且可能为患者提供更好的耐受性。目前在接受透析的终末期肾病患者中进行的关键性3期临床试验项目已经完成首批患者入组。 GondolaBio 轮次：未知轮金额：3亿美元日前，BridgeBio Pharma公司披露，在投资者的支持下成立了一家名为GondolaBio的新公司，并将针对红细胞生成性原卟啉症、α-1抗胰蛋白酶缺乏症和结节性硬化症的早期临床和临床前项目转移到GondolaBio继续开发。此次GondolaBio的投资者包括Viking Global Investors LP、Patient Square Capital、红杉资本（Sequoia Capital）、Frazier Life Sciences、Cormorant Asset Management、Aisling Capital等机构。这些投资者承诺提供3亿美元的分期融资。同源康医药轮次：IPO 金额：5.06亿港元 8月20日，同源康医药正式在港交所上市，募资约5.06亿港元，约70%将用于核心产品的研究、开发及商业化，约20%将用于其他候选产品研发，约3%将用于潜在战略收购或合作机会。同源康医药致力于开发差异化癌症靶向疗法，以满足亟待满足的医疗需求，尤其是肺癌领域。该公司已建立由11款候选药物组成的管线，包括处于3期关键临床阶段的核心产品TY-9591（第三代EGFR-TKI）、其他6款临床阶段产品，以及4款临床前或早期开发阶段产品。 Vandria SA 轮次：A轮融资金额：3070万美元 8月21日，开发线粒体疗法的Vandria SA宣布完成A轮融资的第二次融资，使其总融资金额达到3070万美元（2830万瑞士法郎）。此次Hevolution Foundation和Dolby Family Ventures加入成为投资方，原创始风险投资公司为ND Capital。 Vandria正在开发一种新靶点小分子诱导剂，可诱导线粒体吞噬（选择性去除和替换受损线粒体）和抗炎作用，有望治疗与年龄相关的慢性疾病。其主要候选者VNA-318在临床前研究中被证明可显著改善记忆和学习。VNA-318在阿尔茨海默病和帕金森病模型中具有强疾病调节作用。而且毒性研究表明其具有广泛的安全窗口。除了VNA-318，Vandria还拥有其他促有丝分裂的小分子管线，以解决肌肉、肺和肝脏疾病中未满足的医疗需求。 PhotonPharma 轮次：种子轮金额：250万美元 8月21日，PhotonPharma宣布完成250万美元的种子轮融资。这笔资金将支持Innocell™的1期临床试验，这是一种治疗晚期癌症的新疗法。该公司成立于2018年，致力于开创新型药物输送系统和靶向治疗，旨在改善癌症治疗。2024年2月，PhotonPharma获得美国FDA的批准开始进行Innocell™的临床开发。临床1期试验预计将于2024年第四季度招募首位患者。 Talus Bioscience 轮次：种子+轮金额：1120万美元 8月20日，Talus Bioscience宣布获得1120万美元的种子+轮融资，由Two Bear Capital领投，WRF Capital、NFX、YC Continuity Fund、Funders Club VC和BoxOne Ventures参投。融资资金将用于推进其在研治疗项目，包括短距离驱动癌症和一种与前列腺有关的非药物转录因子等。 Talus Bio创立于2020年，专注于转录因子调节相关疾病的治疗研发。转录因子通过与DNA结合来协调基因开关进而调节蛋白表达。当它们出现问题时，通常会导致癌症和其他疾病过程。该公司专有发现平台MARMOT（转录因子正常调节的多重检测）集成了人工智能、下一代蛋白质组学、合成化学和计算生物学来设计和研究药物、蛋白质和基因组学。希望在投资市场的助力下，更多前沿技术和创新疗法可以早日造福病患。参考资料： [1]各公司官网和公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

并购临床2期免疫疗法信使RNA寡核苷酸

2024-08-21

·GlobeNewswire-Health Care

Pharmazz Inc. and Sun Pharma entered into an agreement under which Sun Pharma will invest up to $15 Million in Pharmazz, Inc.

Strategic equity investment of $15 M to support completion of Pharmazz's pivotal Phase 3 study for Sovateltide to treat patients with acute cerebral ischemic strokeExpansion of the exclusive license agreement with Sun Pharma for marketing and distribution of Sovateltide in India to certain additional Emerging Market countries WILLOWBROOK, Ill., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that it has entered into an agreement with Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or affiliated companies) to support development of Sovateltide and extend the scope of its strong working relationship to commercialize a first-in-class innovative drug, Sovateltide (Tyvalzi™). Developed by Pharmazz for potential global use, Sovateltide is indicated for treating acute cerebral ischemic stroke in markets where it is launched. Pursuant to the agreement, Sun Pharma will make a strategic equity investment of $15 M in two tranches, subject to certain conditions, to support the development of Pharmazz's lead compound, Sovateltide, through a pivotal Phase 3 trial in the U.S. to treat patients with acute cerebral ischemic stroke. As the world's leading specialty generic pharmaceutical company, Sun Pharma’s equity investment further validates the promising developmental pathway for Sovateltide. Previously, Pharmazz entered into a license agreement with Sun Pharma to commercialize Sovateltide in India under Sun Pharma owned brand name Tyvalzi™. This collaboration is now being expanded to drive the asset’s commercialization efforts in certain additional Emerging Market countries. Sun Pharma’s investment and collaboration will bring valuable operational expertise and strategic inputs to the Pharmazz management team. About Sovateltide Sovateltide is a first-of-its-kind drug to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of Sovateltide for treating acute cerebral ischemic stroke patients. The protocol is titled, “A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke.” ClinicalTrials.gov ID: NCT05691244. Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. It can be given to patients along with thrombolytic, and about 30,000 acute cerebral ischemic patients have been treated in India. About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz obtained marketing authorization for two of its first-in-class drug molecules, Centhaquine and Sovateltide, for hypovolemic shock and acute cerebral ischemic stroke, respectively, in India. In addition, the U.S. Food and Drug Administration (FDA) has approved two phase III INDs for Centhaquine as an agent for hypovolemic shock and Sovateltide for acute cerebral ischemic stroke. Additional information may be found on the Company’s website, www.pharmazz.com, and follow us on LinkedIn & X (Formerly Twitter). About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world’s leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma’s high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company’s vertically integrated operations deliver high quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be “forward-looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors Media David Costello Shruti Gulati Tel+1 630 780 6087Tel+1 630 780 6087E maildavid.costello@pharmazz.comE mailshruti.gulati@pharmazz.com

临床3期引进/卖出上市批准

2024-06-22

·药事纵横

2024年印度药企排名TOP10

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。印度是全球仿制药的领导者，正处于增长和创新的重要关头。印度拥有一些全球最知名的制药公司，在全球医疗保健领域发挥着举足轻重的作用。最近的趋势表明，印度制药公司研发投资激增，将重点扩大到开发新型疗法和生物仿制药上，这种演变使印度成为全球制药业的重要参与者，同时满足国内和国际需求。本文将深入探讨印度十大制药巨头，剖析其成就、贡献和未来前景。排名的衡量标准主要是依据其总收入，当我们浏览这些公司的领先指标时，我们发现的不仅仅是其经济影响，还有对研究、开发和社会福祉的承诺。营收排名根据印度2024财年（2023Q2-2024Q1）营收数据统计，前10大药企如下所示： TOP1 Sun Pharma（太阳制药）印度十大制药公司排名中名列第一的为太阳制药，因其创新产品和尖端研究而备受赞誉。太阳制药是印度市值最高的制药公司，目前市值为3.47万亿 INR（416.57亿美元）。根据报告，印度医药市场规模达1.97万亿美元，Sun Pharma排名第一，市场份额为8.5%。 2024财年合并业绩显示，公司总收入4985.1亿卢比（59.8亿美元），同比增长11.97%，税后利润（PAT）957.6亿卢比（11.5亿美元），同比增长13.01%。公司销售总额为4775.85亿卢比（57.37亿美元），增长10.4%。制剂总销售4557.08亿卢比（54.86亿美元），其中印度制剂1488.93亿卢比（17.93亿美元），增长9.5%；美国制剂1534.93亿卢比（18.54亿美元），增长10.1%；新兴市场制剂861.95亿卢比（10.41亿美元），增长5.9%；其他地区制剂销售671.28亿卢比（8.11亿美元），增长7.8%。该公司的产品包括仿制药和品牌药。公司的产品组合包括治疗精神、神经、肾脏、肠胃、骨科、眼科疾病和失调以及心脏病的产品。Sun Pharma的产品通常是市场上最实惠、最易获得的产品之一，因此最受医疗保健专业人士的青睐。同时，该公司在发达市场和新兴市场都占有一席之地，这为其未来的进一步发展奠定了良好的基础。 Sun Pharma专科研发管线包括6个正在进行临床研究的分子。该公司在美国市场拥有全面的产品组合，包括531项已获批准的ANDA，还有104项ANDA在等待美国FDA批准。此外，产品组合中还包括51个已获批准的NDA，另有14个NDA尚待美国FDA批准。 TOP2 Aurobindo Pharma Aurobindo Pharma是一家全球制药公司，总部设在印度海得拉巴市。该公司主要生产仿制药和药物活性成分（API）。公司的业务范围包括六大治疗产品领域：抗生素、抗逆转录病毒药物（主要治疗艾滋病）、心血管产品、中枢神经系统产品、胃肠道用药和抗过敏药等等，不仅如此其还生产膳食补充剂，健康管理类OTC药物，也是多肽（peptide）等原料药的生产商。Aurobindo已经在超过150个国家销售这些产品，90%以上收入来自国际业务，营销合作伙伴包括阿斯利康和辉瑞。 2024财年Aurobindo总收入2955.93亿印度卢比（35.47亿美元），同比增长17.55%；业务收入达2900.2亿印度卢比（34.79亿美元），同比增长16.7%。其中Q4总收入771.58亿印度卢比（9.25亿美元），业务收入758.02亿印度卢比（9.09亿美元），同比增长17.1%。 FY2024 制剂收入为2441.9亿印度卢比（29.29亿美元），同比增长了18.7%；其中美国制剂市场收入1386.7亿美元，同比增长23.5%，占合并收入的47.8%；欧洲制剂市场收入716.6亿美元，同比增长11.5%，占合并收入的24.7%。原料药业务收入同比持平，为424.1亿印度卢比（5.09亿美元），占合并收入的14.6%。截至2024年3月31日，公司累计向美国FDA提交了830项ANDA，并获得了658项最终批准和27项暂定批准；其中Q4新提交了11项ANDA，有17项ANDA获得最终批准，其中包括4种特殊产品和注射产品。 TOP3 Dr. Reddy’s Laboratories 来自于印度的瑞迪博士实验室有限公司（Dr. Reddy's Laboratories，DRL）是一家综合性制药上市公司（股票代码：RDY），成立于1984年，总部位于印度海德拉巴，2001年上市纽交所（目前总市值亿美元，约亿人民币）。DRL的业务遍及全球，主要市场包括——美国、印度、俄罗斯和独联体国家以及欧洲。 2024财年DRL总营收2791.64亿印度卢比（约33.5亿美元），同比增长13.5%，主要得益于北美、欧洲和新兴市场仿制药的强劲表现；研发费用228.73亿印度卢比（2.74亿美元），同比增长18%。其中全球仿制药收入为2455亿印度卢比（29.4亿美元），同比增长15%，增长的主要原因是基本业务量的增加和新产品的推出，但部分增长被美国和欧洲的价格侵蚀所抵消。分地区来看，2024财年北美地区收入1299亿印度卢比（15.56亿美元），同比增长29%；欧洲地区收入205亿印度卢比（2.46亿美元），同比增长17%，增长的主要原因是利用了投资组合的杠杆作用和基础业务的发展势头；印度地区收入464亿印度卢比（5.56亿美元），同比增长5%；在俄罗斯、罗马尼亚、西欧等新兴市场中的收入共计486亿印度卢比（5.82亿美元），同比增长7%，这一增长得益于新产品的推出和市场份额的扩大。本季度，CRL在该地区多个国家推出了17种新产品，使全年新产品总数达到106种。 2024财年DRL与赛诺菲建立独家合作伙伴关系，在印度推广和分销其疫苗品牌；与拜耳公司合作，在印度分销心力衰竭治疗药物Vericiguat的第二个品牌；与美国生物制药公司Pharmazz签订许可协议，在印度销售首创的Centhaquine (Lyfaquin®)，用于治疗低血容量性休克。此外还在英国推出抗过敏药物 Histallay®和首款生物仿制药Bevacizumab。该公司主要治疗领域是胃肠道疾病、心血管疾病、糖尿病、肿瘤、疼痛管理和皮肤科学疾病。通过自身完整的药品价值链，DRL提供包括原料药、仿制药、生物类似药、差异化复杂制剂、新药/新分子实体等一系列产品组合和多种医药定制服务。目前在全球56个国家和地区有400余种药品上市销售。 TOP4 Cipla Cipla（西普拉）由Dr. K. A. Hamied创立于1935年，是一家全球制药公司，是印度第三大制药公司，其呼吸系统疾病药物在印度市场更是排在首位。专注于复杂的仿制药，在呼吸、泌尿外科、心脏病学、抗感染和中枢神经等领域都有优势，Cipla目前主要深耕的市场在印度、南非、北美，且在世界各地有46个生产基地，约生产50多种剂型和1500多种产品。该公司2024财年营收2545.5亿印度卢比（30.5亿美元），相比去年同期增长了14%，息税前营业利润623.3亿印度卢比（7.47亿美元），同比上涨26%。其中第四季度营收616.3亿印度卢比（7.38亿美元），同比增长10%。 Cipla按市场区域和业务特征将业务划分为6大业务，印度本土业务是该公司营收的主要来源，占该公司总营收的43%；北美业务是该公司营收的第二大来源，占总营收的30%。撒哈拉以南的非洲业务是Cipla营收的第三大来源，占比12%；国际业务（含欧洲市场和新兴市场）营收占比12%；原料业务营收占比2%；其他业务营收占比1%。在投资方面，Cipla南非公司以9亿南非兰特（0.48亿美元）收购Actor Pharma，释放南非市场增长机会，增强南非的非处方药产品组合,重点在妇女保健、抗感染和儿科系列产品；投资1.3亿印度卢比收购Ivia Beaute，包括Astaberry®（与里程碑相关的1.1亿印度卢比），进军化妆品和个人护理领域。总结印度制药业集创新、经济性和质量于一身，这十大公司就是印度制药业的缩影。它们的集体影响远远超出了财务指标，对全球医疗保健做出了重大贡献。随着这些公司继续投资研发并扩大全球业务，它们将不仅是行业领导者，更是全球医疗保健系统的生命线。印度是主要的药品出口国，印度药品出口服务于200多个国家。印度供应了非洲50% 以上的仿制药需求、美国约40%的仿制药需求以及英国约25%的药品需求。印度制药业目前估值为500亿美元，预计到2024年将达到650亿美元，到2030年将达到1300亿美元。参考资料：各公司官网

财报上市批准

100 项与 Centhaquine Citrate 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
出血性休克	印度	Pharmazz, Inc.	2020-05-14

未上市

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床2期	-	Pharmazz, Inc.	2024-03-31
成人呼吸窘迫综合征	临床2期	-	Pharmazz, Inc.	2024-03-31
休克	临床1期	印度	Pharmazz, Inc.	2019-01-31
出血	临床1期	印度	Pharmazz, Inc.	2017-05-29

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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


NCT04045327 (Pubmed \| Drugs) 人工标引	临床3期	休克	105	Centhaquine	(夢簾獵廠艱鹹鑰觸夢築) = 遞齋鬱範壓繭夢鹽遞齋鹹顧鏇鹽廠鬱選窪艱壓 (糧獵構鏇築衊範構範齋 ) 更多	积极	2021-06-01
				Placebo	衊廠觸襯夢齋觸範鹽餘(餘簾醖襯簾壓壓壓構願) = 網夢簾網夢製築觸遞積繭網範簾範範鏇鑰鬱廠 (鏇膚餘壓鬱糧憲構鏇壓 ) 更多
NCT04045327 (Pubmed)	临床3期	休克辅助	197	Centhaquine (Lyfaquin®)	(構齋窪淵顧願艱夢糧顧): odds ratio = 4.4 (95% CI, 0.9651 ~ 23.74), P-Value = 0.037 更多	积极	2020-11-05
				centhaquine (Lyfaquin®) (Control)
Pubmed \| J Surg Res	N/A	出血性休克	-	Centhaquin	(網襯淵鏇齋糧鹹艱淵憲) = 築觸選衊艱選積夢膚簾獵簾廠醖窪積醖獵餘鑰 (壓獵窪遞鬱鹹壓窪鹽遞 ) 更多	-	2013-01-01
				Large-volume lactated Ringer (LR) solution	艱衊構築遞鬱窪繭簾製(衊夢願鹽積淵範願遞鏇) = 積廠顧簾衊鹹鹹醖憲築獵齋獵遞夢顧鏇齋襯淵 (壓遞糧遞壓網繭齋憲艱 ) 更多