Randomized, Double-Blind, Pharmacokinetic (PK) and Glucodynamic (GD) Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) of Rapid Acting Insulin Analogs With and Without Recombinant Human Hyaluronidase (rHuPH20)

The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).
This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2. Stage 2 was not initiated due to a strategic business decision and termination was not based on safety or efficacy concerns. No participants were enrolled in Stage 2.

开始日期2011-01-01

申办/合作机构

Halozyme Therapeutics, Inc.

NCT01194245

/ Completed临床2期

A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

开始日期2010-08-01

申办/合作机构

Halozyme Therapeutics, Inc.

NCT00979875

/ Completed临床1期

Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic, 6-Way Crossover Study of Subcutaneously Administered Insulin Analogs With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Analogs Alone in Healthy Volunteers

This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

开始日期2009-09-01

申办/合作机构

Halozyme Therapeutics, Inc.

100 项与 Insulins(Halozyme) 相关的临床结果

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100 项与 Insulins(Halozyme) 相关的转化医学

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100 项与 Insulins(Halozyme) 相关的专利（医药）

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项与 Insulins(Halozyme) 相关的文献（医药）

2026-01-01·Drug Delivery and Translational Research

A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidase

Article

作者: Knowles, Stephen P ; Nekoroski, Tara ; Connor, Robert J ; Kindig, Susan K ; LaBarre, Michael J ; Kang, David W ; Bitsura, Jo Ann M

Abstract:

Until recently, approved handheld auto-injectors (AIs) have been limited to volumes ≤ 2 mL. A prototype rapid high-volume AI (HVAI) that can deliver 10 mL in 30 s was developed to administer therapeutics co-formulated with a proprietary recombinant human hyaluronidase PH20 (rHuPH20). This phase I, open-label study assessed the tolerability of subcutaneous (SC) injections of 10% (100 mg/mL) immunoglobulin G (IgG) solution co-administered with 4000 U/mL rHuPH20, delivered using a syringe pump at a target rate of 5 or 10 mL/30 seconds or the prototype HVAI at a target rate of 10 mL/30 seconds in healthy human subjects. Subjects received 5 mL (Cohort A, n = 12) or 10 mL (Cohort B, n = 12) of test solution via syringe pump (injection visit 1), and 10 mL of test solution via HVAI (Cohorts A & B; injection visit 2). Primary endpoints were tolerability and safety outcomes. Secondary endpoints included HVAI injection duration. All 24 subjects completed visit 1; 23/24 completed visit 2. All injections were tolerated, with no serious adverse events (AEs). Following syringe pump administration, 6/24 subjects (25%) reported eight treatment-emergent AEs (TEAEs); after HVAI administration, 4/23 (17%) reported four TEAEs, all mild in severity. Mean (± SEM) injection duration via HVAI was 27.9 ± 0.8 s. Most subjects (91%, 21/23) experienced no or mild injection-site pain following HVAI administration, and 96% (22/23) said they would be willing to have the HVAI injection again. SC injection of a 10% IgG solution in combination with rHuPH20 was well tolerated at an injection rate of 10 mL/~30 s using the prototype HVAI.

2025-12-01·BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

Patients' Attitudes Towards Deprescribing Differ Across Specific Cardiovascular and Diabetes Medication: A Survey Study Assessing Within‐Patient Differences

Article

作者: Stuijt, Peter J. C. ; Taxis, Katja ; van Munster, Barbara C. ; Wildeboer, Anita T. ; Denig, Petra ; Crutzen, Stijn ; Hootsen, Jessica V. ; Heringa, Mette

ABSTRACT:

Background:

Knowing whether patients' attitudes towards deprescribing differ by medication is important for implementing deprescribing in practice.

Objective:

To assess whether there are within‐patient differences in attitudes towards deprescribing the following cardiovascular and diabetes medications: statins, antihypertensives, sulfonylureas and insulins.

Methods:

We administered the revised Patient Attitudes Towards Deprescribing questionnaire to Dutch primary care patients. The ‘appropriateness’ and ‘concerns’ factors were adapted to measure medication‐specific attitudes. Pairwise comparisons of appropriateness and concerns factor scores were tested with Wilcoxon signed‐rank tests and corrected to control the false discovery rate.

Results:

Responses from 160 patients (median age: 79 years, 34% frail) were used for the comparisons. Appropriateness factor scores were higher for insulins compared to statins ( n = 18, 3.9 versus 3.3, p < 0.031), antihypertensives ( n = 21, 4.0 versus 3.6, p < 0.031) and sulfonylureas ( n = 12, 3.8 versus 3.4, p < 0.031) and higher for sulfonylureas compared to antihypertensives ( n = 26, 3.6 versus 3.4, p = 0.036) and statins ( n = 27, 3.6 versus 3.2, p = 0.006). No statistical differences were found for the concerns factor scores.

Conclusion:

Given the observed differences in appropriateness attitudes, patients may be more positive towards deprescribing statins and antihypertensives as compared to sulfonylureas and particularly insulins. Healthcare providers should be aware that patients can experience medication‐specific barriers when discussing options for deprescribing.

2025-12-01·JOURNAL OF AFFECTIVE DISORDERS

Updated insights on memory disorder associated risk of medication: A real-world pharmacovigilance analysis

Article

作者: Chen, Quanshun ; Yu, Qing ; Zhu, Hong ; Mao, Mingyang ; Wang, Mei ; Yang, Yi ; Wan, Tao ; Zhao, Jie

OBJECTIVE:

This study aims to use the Food and Drug Administration Adverse Event Reporting System (FAERS) to identify medications linked to memory disorders and to offer updated insights into medication-induced memory disorders.

METHODS:

We analyzed adverse event (AE) reports related to memory disorders in the FAERS database from 2004 to 2023 and compiled a list of potential medications along with their associated AEs. The disproportionality analysis was employed to assess the potential associations between medications and memory disorder events.

RESULTS:

The study identified 194,754 memory-related AEs in the FAERS database, revealing a higher prevalence in females (62.11 %) compared to males (32.76 %). A comprehensive medication list was summarized, comprising 374 potential medications that may contribute to memory disorders. The top 50 medications linked to memory impairment, amnesia, and dementia have been compiled and categorized accordingly. Overall, immunosuppressants represented the medication category with the highest incidence of AEs, followed by immunostimulants, other analgesics and antipyretics, antiepileptics, insulins, antidepressants, angiotensin II receptor blockers, antipsychotics, and lipid-modifying agents. The median time-to-onset (TTO) of memory-related AEs was 59 days (interquartile range [IQR] 1-503), with most medications exhibiting early failure types as determined by the Weibull shape parameter (WSP) analysis. The medications most frequently linked to memory disorders in minors were montelukast, atomoxetine, methylphenidate, lamotrigine, zanamivir, and somatropin.

CONCLUSIONS:

This study presents a comprehensive overview of medications that induce memory disorder from a pharmacovigilance perspective, may offering certain references for clinical practice. However, further research is required necessary to elucidate these associations.

项与 Insulins(Halozyme) 相关的新闻（医药）

2025-12-12

·ETPharma

Novo Nordisk injects diabetes blockbuster Ozempic’ into India business

New Delhi: Expanding its GLP-1 receptor agonist franchise, Danish drug giant Novo Nordisk has announced the launch of its type-2 diabetes blockbuster brand Ozempic ( Semaglutide ) in India. Ozempic , a once-weekly injectable initially approved for managing type 2 diabetes and later recognized for its weight-loss benefits, has been launched at a starting price of Rs 2,200 for the 0.25 mg introductory dose. The drug will be marketed in its FlexTouch pen, which covers the monthly schedule of four doses and is priced at Rs 8,800 for the 0.25 mg pen, Rs 10,170 for 0.5 mg and Rs 11,750 for the 1 mg pen. Speaking to reporters at the drug launch, Vikrant Shrotriya , MD, Novo Nordisk India, said that bringing the therapy under this price bracket was a "tough decision," and the brand’s current pricing is virtually in line with that of insulins. With this launch, the company now offers the full spectrum of its Semaglutide-based therapies, including, Rybelus and Wegovy . Ozemopic developed from the active ingredient Semaglutide mimics the gut hormone GLP-1, prompts the body to release more insulin when blood sugar levels are high, leading to significant drops in A1C levels (key marker for diabetes) in the range of 1.2 and 1.9 percentage points. The type-2 diabetes brand is the company's highest-selling asset, that clocked nearly $17 billion in 2024. In India, while the Danish giant was ahead in securing regulatory clearance for its Semaglutide molecule, its arch-rival Eli Lilly leapfrogged the competition by launching Mounjaro (Tirzepatide), a dual GIP/GLP-1 therapy, in March—ahead of the June debut of Wegovy (Ozempic’s weight-loss sibling). Regarding the drug's delayed entry into India against other major global markets, Shrotriya stated "underestimation of demand led to shortage of supplies", compelling the company to defer the introduction of its therapies in the country So far Wegovy has clocked net sales of Rs 50 crore, however against Mounjaro —the drug sales dwarfs, which is leading the charts with a moving annual turnover of Rs 496 crore, according to PharmTrac estimates. Amid a tepid response to its weight-loss brand, the entry of Ozempic may provide the company some breathing room, considering its strong brand awareness and established efficacy over adjacent comorbidities alongside the steep burden of diabetes in the country. By Online Bureau ,

上市批准

2025-12-12

·国际糖尿病idiabetes

立足医学循证，聚焦临床实践：从基础胰岛素周制剂看新型降糖药物转化之旅

点击“蓝字”关注我们导语近20多年来，糖尿病治疗领域不断加速创新，多种新型降糖药物持续涌现。然而，新型治疗药物从产生医学循证证据到真正改变临床实践，往往需要经历漫长的转化过程，平均周期可达17年之久[1]。该过程始于候选药物的筛选，历经多次临床前与临床研究，并基于循证证据制定临床决策，最终在实践中结合患者情况实现个体化治疗，其间充满障碍和挑战[2]。在糖尿病治疗领域，如何推动新型降糖药物实现从医学循证到临床实践的快速转化，是一项值得关注的重要健康议题[3]。以全球首个基础胰岛素周制剂依柯胰岛素为例，本文将探讨新型降糖药物如何在研究阶段有效验证其疗效与安全性、在转化阶段有效促进临床实际应用，从而成功跨越从医学循证到临床实践的转化之旅。研究阶段：立足基础胰岛素周制剂医学循证依柯胰岛素通过不同的临床研究阶段，实现医学循证的逐步累积[4-18]：首先，基于创新的分子设计，在临床前期阶段进行了一系列最基本的药理、毒理等临床前动物研究；1期临床阶段则针对2型糖尿病（T2DM）、1型糖尿病（T1DM）、肝肾功能不全等患者，进行了系统的药理评估，并首次评价用于人体的安全性，同时确定安全剂量，识别副作用；随后，在纳入T2DM患者的2期研究中测试了药物的临床有效性，并进一步评估安全性，进行概念验证，并决定进入3期临床研究阶段；在一系列3期临床研究ONWARDS项目中，纳入更大规模、更多不同治疗背景的糖尿病患者，系统确认了依柯胰岛素作为新型降糖药物的临床疗效和安全性；最终，基于充分的循证证据获得了监管部门的批准，可以应用于临床。但至此，依柯胰岛素的医学循证累积尚未结束，其应用于临床后的研究正在开展中，例如4期临床研究EFFICIENT（NCT07112339），计划纳入586例既往未使用过胰岛素的T2DM患者，评估依柯胰岛素在真实世界中的疗效和安全性[19]。根据不同阶段的临床研究结果，依柯胰岛素作为新型基础胰岛素周制剂的分子特点、作用机制、药理特征、临床疗效和安全性状况等得以明确。临床前阶段依柯胰岛素基于脂肪酸酰化技术，首次实现基础胰岛素每周一次注射（图1）。其通过在人胰岛素分子上连接20碳脂肪酸侧链，同时替换3处氨基酸，实现与白蛋白强效且可逆的结合，并减缓胰岛素受体介导的清除，进而使得活性胰岛素从白蛋白储库中缓慢而持续释放，如“涓涓细流”作用于靶器官和组织，实现长效血糖控制[4,5]。图1. 依柯胰岛素的分子结构与长效机制 1期临床阶段在1期药代动力学（PK）与药效动力学（PD）研究中，依柯胰岛素表现出显著的长效特性[5]。PK分析显示其半衰期长达196小时；PD结果表明，在稳态下葡萄糖输注率曲线下面积（AUCGIR）在7天内的分布比例为12.0%~16.3%，提示其每周一次注射降糖疗效日间分布接近平均（图2）。PK与PD数据一致支持依柯胰岛素每周一次给药。图2. 依柯胰岛素半衰期长达196小时，每周一次注射降糖疗效日间分布接近平均在中国T2DM患者中进行的PK研究[6]同样显示，依柯胰岛素每周一次注射，约3~4周后达稳态，其稳态血药浓度谱与白种人相似，能够覆盖一周的给药间隔，半衰期也支持其每周一次注射在中国T2DM患者中同样适用。 2期临床阶段依柯胰岛素的3项2期临床研究共纳入606例T2DM患者，初步验证了其疗效与安全性。其中一项研究显示，依柯胰岛素在降糖疗效和安全性方面与甘精胰岛素U100相当[7]；另一项滴定试验确定了依柯胰岛素的剂量调整方案[8]；还有一项转换试验则明确了已使用胰岛素治疗的T2DM患者如何转换为依柯胰岛素治疗[9]。基于上述2期临床研究结果，确定在后续3期临床试验中：依柯胰岛素治疗时，设定空腹血糖（FPG）目标为4.4~7.2 mmol/L；依柯胰岛素以每周±20 U进行剂量调整；对于已使用其他基础胰岛素的患者，转换为依柯胰岛素治疗时，将每日基础胰岛素总剂量乘以7，并在首次注射时给予一次性50%的额外剂量。 3期临床阶段 ONWARDS 1~5为随机、多中心、双臂、3a期临床研究，共纳入3765例不同治疗背景的T2DM患者，评估依柯胰岛素相较于基础胰岛素日制剂的疗效与安全性（图3）[10-14]。其中，ONWARDS 1、3、5研究针对未使用过胰岛素治疗的T2DM患者，探讨起始依柯胰岛素治疗的疗效和安全性；ONWARDS 2、4研究则针对已使用胰岛素治疗的T2DM患者，评估转换为依柯胰岛素治疗的疗效与安全性。此外，ONWARDS 5研究在随机对照设计中融入真实世界元素，更贴近真实临床实践。图3. ONWARDS 1~5研究：系统评价依柯胰岛素在T2DM中的疗效与安全性降糖疗效无论既往是否使用胰岛素，依柯胰岛素治疗均能显著降低糖化血红蛋白（HbA1c），降幅0.93%~1.68%，在ONWARDS 1、2、3、5研究中，其降糖效果优于基础胰岛素日制剂[10-14]。依柯胰岛素降低FPG效果与基础胰岛素日制剂相当[10-14]。ONWARDS 1研究进一步显示，在未使用过胰岛素的T2DM患者中，依柯胰岛素组的葡萄糖目标范围内时间（TIR3.9~10 mmol/L，71.9% vs. 66.9%）和葡萄糖高于目标范围时间（TAR>10 mmol/L，6.7% vs. 8.9%）均显著优于甘精胰岛素U100组；ONWARDS 2和4研究中，在已使用胰岛素的T2DM患者中，依柯胰岛素组的TIR和TAR与基础胰岛素日制剂相当[13-16]。安全性无论既往是否使用胰岛素，依柯胰岛素与基础胰岛素日制剂的低血糖发生率相似。ONWARDS 1、2、3、5研究显示，依柯胰岛素治疗的临床显著或严重低血糖发生率均较低（<1事件/患者年）；ONWARDS 4研究中，依柯胰岛素治疗的低血糖发生率与基础胰岛素日制剂相当[10-14]。持续葡萄糖监测（CGM）数据进一步证实，依柯胰岛素治疗的葡萄糖低于目标范围时间（TBR<3.0 mmol/L）均低于推荐目标，与基础胰岛素日制剂相似[13-16]。此外，两组体重变化亦无显著差异[10-14]。治疗满意度与依从性 ONWARDS 2和5研究中患者报告结局，以及ONWARDS 1研究中医生治疗满意度调查均显示，依柯胰岛素可显著提高治疗满意度和依从性。相较于日制剂，93.7%的患者倾向于选择周制剂，主要原因为注射频次减少、操作更便捷及血糖控制更优[17]。中国亚组分析 ONWARDS 3研究中国亚组（n=145）事后分析显示，依柯胰岛素在中国T2DM患者中的疗效和安全性与全球人群一致。与德谷胰岛素相比，依柯胰岛素在HbA1c改善方面更优，两组低血糖发生率均较低，体重变化和平均胰岛素周剂量相似[18]。基于上述充分的循证医学证据，可以明确的是：依柯胰岛素每周一次注射，能够显著提高治疗依从性，降糖疗效非劣效甚至优于基础胰岛素日制剂，且安全性相当。依柯胰岛素的应用有助于消除血糖管理不佳的障碍；临床医生可通过持续监测并指导依柯胰岛素的使用，进一步支持T2DM患者的自我管理能力[20]。转化阶段：聚焦基础胰岛素周制剂临床实践将临床研究和循证证据系统性地整理为科学信息进行传递，并结合实际临床情况制定指南建议，将帮助和支持创新治疗在临床上的广泛应用，从而真正转化为临床实践，以提高患者可及性和健康结局。当前，已有多个指南与专家建议为依柯胰岛素的临床应用提供指引[21-23]。《中国糖尿病防治指南（2024版）》对基础胰岛素在T2DM胰岛素治疗路径中的位置进行了明确推荐，基础胰岛素可用于起始和强化胰岛素治疗，并指出依柯胰岛素作为长效胰岛素类似物周制剂，能安全有效降糖同时显著改善患者治疗满意度和依从性[21]。现有专家观点和指导建议对临床实践中依柯胰岛素应用的具体建议如下[22,23]：适用患者人群依柯胰岛素适用于需要基础胰岛素治疗的成人T2DM患者：在生活方式干预基础上，经口服降糖药治疗3个月后HbA1c仍不达标者，可考虑起始联合依柯胰岛素；已使用基础胰岛素日制剂且FPG已达标但希望减少注射次数者，或FPG控制不达标者，可考虑转换为依柯胰岛素治疗并进一步调整剂量[23]。临床使用方法起始剂量对于未使用过胰岛素治疗的T2DM患者，起始剂量推荐70 U/周（相当于基础胰岛素日制剂10 U/天），也可参照基础胰岛素日制剂起始剂量：通常为0.1~0.2 U/kg/天，HbA1c>8.0%者0.2~0.3 U/kg/天，体质指数（BMI）≥25 kg/m2者0.3 U/kg/天。依柯胰岛素所需剂量按“基础胰岛素日制剂的剂量×7”计算[23]。转换剂量对于已使用胰岛素治疗的T2DM患者，若FPG已达标且需减少注射次数，推荐将每日基础胰岛素总剂量×7作为转换后的依柯胰岛素周剂量；若FPG未达标，则第1周转换时，以每日基础胰岛素总剂量×7并一次性增加50%额外剂量[23]。当然，依柯胰岛素的起始和转换剂量均可根据患者个体化情况（如低血糖风险、当前血糖与控制目标间差值）进行调整[23]。剂量调整起始治疗者，第2周开始调整剂量。转换治疗者，如果第1周未加用一次性额外剂量，第2周开始调整剂量；如果第1周已加用额外剂量，第2周无需再加，第3周开始调整剂量。根据早餐前FPG值（当日及前2日共3次）调整剂量：若高于目标范围（4.4~7.2 mmol/L）则+20 U，低于目标范围则-20 U；若3次血糖值均在目标范围下限之上，则依据3次平均值调整；若任1次低于目标范围下限，则基于最低值调整。随后每周进行个体化剂量调整，直至血糖达标[23]。特殊患者人群依柯胰岛素用于老年及肝肾功能不全患者时，无需针对该人群专门调整剂量，但需加强血糖监测；低白蛋白血症不影响其总暴露量及临床疗效；与胰高糖素样肽-1受体激动剂（GLP-1RA）或钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）联用与否不影响其疗效与安全性；育龄期妇女如已怀孕或计划妊娠，建议转换为其他已获批用于妊娠期的胰岛素；其在儿童患者中应用尚需更多临床研究数据[22]。特殊临床状况依柯胰岛素治疗过程中，若遗漏注射，应尽快补注；如在3天内，可恢复至原给药日；超过3天，则需更改给药日，或将后续给药时间每周延长1~3天，直至达到原给药日。低血糖的预防和管理方法与胰岛素日制剂基本相同。若发生过量注射，应密切监测血糖，及时应对可能出现的低血糖事件。患病期间，需加强血糖监测，并视情况调整基础或餐时胰岛素方案以维持血糖稳定。运动期间，无论胰岛素类型，均需遵循常规建议，使用CGM或增加监测频率，并备好碳水化合物零食。住院期间，其使用与基础胰岛素日制剂类似。禁食期间，应提高血糖检测频率，血糖过低时及时补充葡萄糖[22]。结语从医学循证到临床实践，新型降糖药物的转化过程呈螺旋渐进式向前发展。依柯胰岛素作为全球首个基础胰岛素周制剂，凭借创新的分子设计和坚实的循证证据，实现了从机制探索到疗效验证的跨越。ONWARDS系列研究不仅证实其血糖控制的优效性或非劣效性，更凸显了周制剂在提升依从性与患者满意度方面的优势。随着指南及专家建议的更新与临床路径的明确，依柯胰岛素已日益广泛用于临床实践，为T2DM患者提供更便捷的治疗选择。其转化之旅仍在继续，真实世界数据与长期治疗经验的积累将进一步明确其在复杂临床环境中的优化应用，助力未来T2DM管理。参考文献（上下滑动可查看） 1. Rubin R. JAMA. 2023; 329(16): 1333-1336. 2. Haynes B, Haines A. BMJ. 1998; 317(7153): 273-276. 3. Wilson KM, et al. Prev Chronic Dis. 2011; 8(2): A46. 4. Kjeldsen TB, et al. J Med Chem. 2021; 64(13): 8942-8950. 5. Nishimura E, et al. BMJ Open Diabetes Res Care. 2021; 9(1): e002301. 6. Li Y, et al. J Diabetes Investig. 2025; 16(4): 639-645. 7. Rosenstock J, et al. N Engl J Med. 2020; 383(22): 2107-2116. 8. Lingvay I, et al. Diabetes Care. 2021; 44(7): 1595-1603. 9. Bajaj HS, et al. Diabetes Care. 2021; 44(7): 1586-1594. 10. Rosenstock J, et al. N Engl J Med. 2023; 389(4): 297-308. ONWARDS 1 11. Lingvay I, et al. JAMA. 2023; 330(3): 228-237. ONWARDS 3 12. Bajaj HS, et al. Ann Intern Med. 2023; 176(11): 1476-1485. ONWARDS 5 13. Philis-Tsimikas A, et al. Lancet Diabetes Endocrinol. 2023; 11(6): 414-425. ONWARDS 2 14. Mathieu C, et al. Lancet. 2023; 401(10392): 1929-1940. ONWARDS 4 15. Bergenstal R, et al. 2023 ADA scientific sessions. ePoster 85-LB. 16. Bajaj HS, et al. Diabetes Care. 2024; 47(4): 729-738. 17. Polonsky W, et al. Diabetes Res Clin Pract. 2024; 217: 111885. 18. Li Y, et al. Diabetes Ther. 2025; 16(4): 685-699. 19. Study Details | NCT07112339 | A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes | ClinicalTrials.gov 20. Morales J, et al. Postgrad Med. 2024; 136(8): 791-800. 21. 中华医学会糖尿病学分会. 中华糖尿病杂志. 2025; 17(1): 16-139. 22. Philis-Tsimikas A, et al. Drugs. 2025; 85(10): 1253-1268. 23.《基础胰岛素周制剂依柯胰岛素治疗2型糖尿病临床应用专家指导建议》专家组. 中华糖尿病杂志. 2025; 17(9): 1110-1116. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

2025-12-07

·ETPharma

Biologics merger with Biocon most value-accretive option: Kiran Mazumdar Shaw

Mumbai: Biocon will fully integrate Biocon Biologics as a wholly owned subsidiary in a transaction valuing the biosimilar business at $5.5 billion, as it was the most value-accretive option after “the markets took the Viatris acquisition negatively,” executive chairperson Kiran Mazumdar-Shaw told ET on Saturday. In an interview with Rica Bhattacharyya and Vikas Dandekar, Shaw detailed how the merger removes the holdco overhang, strengthens financial metrics, and provides timely exits for investors such as True North, Tata Capital and Viatris . She also outlined how the combined entity—unique for its interchangeable biosimilar insulins and generic GLP-1 peptides —will unlock synergies across manufacturing, R&D, devices and commercial footprints. ET was the first to report on November 13 that Biocon had appointed Morgan Stanley to evaluate the best value-creation option, including a merger and share swap. Allowing more cash flow The Biocon board has approved raising additional capital of up to ₹4,500 crore ($500 million) through a qualified institutional placement (QIP), which will be largely utilised towards the cash component payable to Viatris, whose global biosimilars business was acquired by Biocon Biologics in 2022. Edited excerpts of the interview: What was the rationale behind the share swap decision, because you were considering other options like an IPO as well? We had earlier expected to take BBL to an IPO because we thought that was the best way of giving an exit to the investors. But the markets took the Viatris acquisition negatively and hammered Biocon’s valuation because of the acquisition debt. We had to also look at a holdco discount. The combination of the two factors completely devalued Biocon’s shares. That, by extension, also affected BBL’s intrinsic value. So, we asked the question that even if we take BBL public, will it result in value unlocking? Then we appointed Morgan Stanley to evaluate all options—IPO, merger, share swap—and decided to buy out the independent stakeholders in Biologics and do a share swap. That automatically makes BBL a wholly owned subsidiary of Biocon and then it becomes a combined business. That way, we will get rid of the holdco discount, be able to see a very robust financial balance sheet, and the whole metrics change—the debt-to-Ebitda ratio has dropped from 4.3 in 2020 to 2.5 today and we are expected to go down even further next fiscal. It puts us in a very strong position, allowing free cash flow. We have also retired the structural equity debt of Kotak and Goldman Sachs and others, which will free up another ₹300 crore of provisioning interest. The governance council and integration management committee have been announced. What are the immediate top three priorities for these bodies over the next 90 days? First is to find out how the new organisation looks. Although it is a very complementary fit, they are also very different, because the manufacturing of small molecules is very different from manufacturing of biologics. But divisions like logistics, IT and some others do not need duplication. We will first look at the organisation structure and how to fit in some people. We will want to accommodate everyone—their roles will not change, but the organisation structure will change a bit. At the top level, we cannot have two CEOs and that’s why we decided that Shreehas Tambe will take over as CEO and MD because he is running the more complex and larger business. But Siddharth Mittal, the current Biocon CEO, is a great leader and we will find a good leadership role for him in the company. If not for the investor pressure and the market's concern about acquisition debt, would you still combine the two businesses? It is not for the investor pressure. We had to find an exit for our investors in Biologics. It was not about Biocon but about our equity investors in Biologics. We had Serum, Tata Capital , True North and Viatris. All of them had to be provided an exit at some stage. Serum had no option but to wait because they had no clause on a specified date. But as far as Viatris was concerned, we had a date of 2030, and for True North and Tata Capital it was 2026. So, there was an urgency in taking this decision—either we had to buy them out or give them an exit. We thought let’s look at a liquidity event that addresses all this. Everyone has benefitted from this merger. Viatris has got a five-year accelerated liquidity event. True North and Tata Capital got what they wanted because they were invested at a certain level, and we actually got a valuation of $5.5-billion swap ratio. If we had gone for an IPO, the debt overhang would probably have reduced the value. Given all that, this is the best option. What are the major benefits from this integration? The combined entity is positioned strongly as a unified global player across both biosimilars and generics, but at the same time both are very different businesses… The fact that we are looking at an Ebitda improvement ratio tells us that there will be good contributions from synergies as well. In three months, we will know what those quantifiable benefits are. We are now focused on the combined business. Overall, we expect strong growth, especially in biosimilars. With the new launches we have had, we expect robust performance. We also have a unique value proposition because we are the only company globally that has biosimilar interchangeable insulins and a portfolio of generic GLP-1s. This puts us in a very strong position because we have end-to-end capabilities. Whether it is manufacturing drug substances, drug products or devices, everything is internal and integrated. We do not have to outsource, and we have scale—something many companies lack. Does the integration accelerate Biocon’s approach to launches in major markets like the US, Europe and Japan? It will certainly accelerate our approach to launches, especially in markets like the US. We are very mature in our commercial footprint when it comes to biosimilars, which is the most complex business. Even in emerging markets, BBL has its own presence in many key regions where Biocon earlier relied on partners. From that perspective, controlling the business in key markets is very attractive. A combined portfolio of biosimilars and generics is also extremely useful. We can accelerate launches, grow the business and derive tremendous synergies. The two businesses are highly complementary. By Vikas Dandekar & Rica Bhattacharyya ,

并购高管变更IPO

100 项与 Insulins(Halozyme) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Insulins(Halozyme)	A10AB05	DB01306

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
1型糖尿病	临床2期	美国	Halozyme Therapeutics, Inc.	2010-08-01
2型糖尿病	临床2期	美国	Halozyme Therapeutics, Inc.	2009-07-01

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临床结果

适应症

分期

评价

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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


NCT03662334 (HALO-117-406, CTgov)	临床4期	1型糖尿病	14	Sham injection	顧簾製製願網廠淵製憲(顧衊繭鬱繭糧選憲蓋艱) = 艱蓋繭遞膚獵繭獵淵糧願築壓膚鏇淵繭膚範餘 (襯鏇鹽廠衊艱鏇遞鑰觸, 網鹽積選簾憲淵憲製餘 ~ 餘鬱齋鑰醖衊鑰遞願襯) 更多	-	2019-02-01
NCT00883558 (CTgov)	临床2期	1型糖尿病	48	recombinant human insulin (INSULIN-PH20 NP)	齋淵窪選積襯獵鹹選鬱(齋鏇範醖繭憲憲餘鹹膚) = 構鹽鏇壓齋憲艱願艱簾遞構壓夢網糧窪廠壓築 (鬱積鹽憲齋淵壓蓋獵窪, 36.040) 更多	-	2014-09-08
				Insulin Lispro (Insulin Lispro)	齋淵窪選積襯獵鹹選鬱(齋鏇範醖繭憲憲餘鹹膚) = 範衊繭構鹽餘製觸願獵遞構壓夢網糧窪廠壓築 (鬱積鹽憲齋淵壓蓋獵窪, 35.113) 更多
NCT00774800 (CTgov)	临床2期	1型糖尿病	22	rHuPH20+Humalog (Humalog + rHuPH20)	餘醖艱構繭網顧憲鏇鏇(積衊繭願壓憲餘餘窪遞) = 鹹構窪壓糧簾簾膚繭顧齋鹹鹹鹽壓範糧鑰醖憲 (壓膚積糧遞鹹窪淵遞遞, 4996.79) 更多	-	2014-09-05
				Humalog (Humalog Alone)	餘醖艱構繭網顧憲鏇鏇(積衊繭願壓憲餘餘窪遞) = 遞襯鏇鬱壓襯鑰製壓襯齋鹹鹹鹽壓範糧鑰醖憲 (壓膚積糧遞鹹窪淵遞遞, 3670.03) 更多
NCT01194245 (CTgov)	临床2期	1型糖尿病	135	recombinant human hyaluronidase PH20+insulin aspart+insulin lispro (Analog-PH20)	夢選齋願壓鏇選築淵繭(網膚淵積鬱窪廠艱淵獵) = 壓淵夢憲鬱糧膚製範範糧顧鏇醖選鬱憲積觸衊 (餘顧窪憲積範鹽廠艱選, 0.415) 更多	-	2014-08-19
				Insulin Lispro (Insulin Lispro)	夢選齋願壓鏇選築淵繭(網膚淵積鬱窪廠艱淵獵) = 齋築積製膚網積觸齋蓋糧顧鏇醖選鬱憲積觸衊 (餘顧窪憲積範鹽廠艱選, 0.440) 更多
NCT00916357 (CTgov)	临床2期	2型糖尿病	23	Humalog (Humalog Alone)	製範製衊壓繭襯糧壓願(顧餘夢顧網積積廠鏇積) = 蓋窪獵鹽夢餘觸繭願遞製遞襯構餘鬱鑰齋築糧 (壓蓋願蓋積窪遞網襯願, 32.28) 更多	-	2014-08-18
				rHuPH20+Humalog (Humalog + rHuPH20)	製範製衊壓繭襯糧壓願(顧餘夢顧網積積廠鏇積) = 遞網顧壓鹽觸選構繭觸製遞襯構餘鬱鑰齋築糧 (壓蓋願蓋積窪遞網襯願, 28.08) 更多
NCT01275131 (CTgov)	临床1期	1型糖尿病	45	Insulin Aspart (Stage 1: Insulin Aspart Alone)	鹹糧網範齋範鑰獵製築(餘範蓋鬱窪鏇繭淵衊淵) = 鑰鑰製膚醖構網繭範鏇襯鏇衊獵膚夢鏇夢醖遞 (觸範製構衊願壓糧廠築, 6.37) 更多	-	2014-07-25
				Insulin Aspart-rHuPH20 (Stage 1: Insulin Aspart-rHuPH20)	鹹糧網範齋範鑰獵製築(餘範蓋鬱窪鏇繭淵衊淵) = 壓夢齋鏇糧網構鹽夢鑰襯鏇衊獵膚夢鏇夢醖遞 (觸範製構衊願壓糧廠築, 9.48) 更多
NCT00705536 (CTgov)	临床1期	糖尿病	26	Humalog (Stage 1: Humalog Alone)	製鬱積鏇膚網醖壓夢蓋(遞夢鑰築憲鑰構製鬱襯) = 窪淵衊夢襯願製膚憲窪憲襯顧獵築蓋膚繭憲衊 (膚積積獵餘醖廠網餘淵, 35.9) 更多	-	2014-07-14
				rHuPH20+Humalog (Stage 1: Humalog + rHuPH20)	製鬱積鏇膚網醖壓夢蓋(遞夢鑰築憲鑰構製鬱襯) = 憲淵艱製壓糧齋糧窪顧憲襯顧獵築蓋膚繭憲衊 (膚積積獵餘醖廠網餘淵, 7.99) 更多
NCT00979875 (CTgov)	临床1期	-	14	Glulisine (Glulisine Alone)	鬱壓齋繭鬱鏇積夢廠醖(憲蓋遞醖憲膚鏇網夢糧) = 膚遞製醖願鬱鏇艱觸積衊蓋獵構簾餘醖製鏇構 (願鬱窪繭襯製鬱範選觸, 4085.00) 更多	-	2014-07-14
				Glulisine+rHuPH20 (Glulisine + rHuPH20)	鬱壓齋繭鬱鏇積夢廠醖(憲蓋遞醖憲膚鏇網夢糧) = 蓋遞壓範獵遞膚觸觸製衊蓋獵構簾餘醖製鏇構 (願鬱窪繭襯製鬱範選觸, 6657.73) 更多
NCT00916357 (Pubmed \| Diabetes Technol Ther)	临床2期	2型糖尿病	21	Insulin Lispro with Hyaluronidase	範窪獵積廠獵觸夢網簾(憲餘蓋蓋夢蓋齋鑰積餘) = 襯醖鬱範繭顧淵鬱膚夢顧廠構築網襯選鏇齋構 (築鏇廠蓋簾築範醖壓構 ) 更多	积极	2012-03-01