A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects

The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.

开始日期2024-05-27

申办/合作机构

派格生物医药（苏州）股份有限公司

CTR20241107

/ Active, not recruiting临床1期

一项单中心、随机、双盲、安慰剂对照、剂量递增研究评价聚乙二醇化艾塞那肽注射液（PB-119）在中国肥胖受试者中的安全性、耐受性和药代动力学特征

评价PB-119连续给药在中国肥胖受试者中的安全性和耐受性。评价PB-119在中国肥胖受试者中的药代动力学（PK）特征；评价PB-119在中国肥胖受试者中的疗效；评价PB-119在中国肥胖受试者中的免疫原性；评价PB-119在中国肥胖受试者中的药效动力学（PD）特征；评价PB-119对中国肥胖受试者的QT间期的影响。

开始日期2024-05-23

申办/合作机构

派格生物医药（苏州）股份有限公司

CTR20220473

/ Completed临床1期

一项评估单次给药聚乙二醇化艾塞那肽注射液（PB-119）在不同程度肾功能不全受试者及匹配的肾功能正常受试者中药代动力学特征的开放性I期临床研究

主要目的：比较PB-119单次给药后在不同程度肾功能不全受试者及匹配的肾功能正常受试者中的药代动力学（PK）特征次要目的：评价不同程度肾功能不全受试者及匹配的肾功能正常受试者接受PB-119后的安全性评价不同程度肾功能不全受试者及匹配的肾功能正常受试者接受PB-119后的肾功能指标和PK参数的相关性

开始日期2022-07-20

申办/合作机构

派格生物医药（苏州）股份有限公司

100 项与聚乙二醇化艾塞那肽相关的临床结果

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100 项与聚乙二醇化艾塞那肽相关的转化医学

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100 项与聚乙二醇化艾塞那肽相关的专利（医药）

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项与聚乙二醇化艾塞那肽相关的文献（医药）

2024-10-01·The Lancet Regional Health - Western Pacific

Efficacy and safety of visepegenatide as an add-on therapy to metformin in patients with type 2 diabetes: a randomised, double-blind, parallel, placebo-controlled, phase 3 study

Article

作者: Liu, Li ; Pang, Wuyan ; Bian, Fang ; Li, Wenhui ; Zhou, Huimin ; Li, Sheli ; Ma, Jianhua ; Jia, Ying ; Ding, Ke ; Xu, Michael ; Yuan, Mingxia ; Yan, Shuang ; Ji, Linong ; Hou, Minghui ; Cai, Xiaoling

BackgroundVisepegenatide, a once-weekly glucagon-like peptide-1 receptor agonist injection, demonstrated effective glycaemic control and good tolerability without the requirement of dose titration in the two completed phase 2 studies. We aimed to evaluate the efficacy and safety of visepegenatide in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin monotherapy in this phase 3 clinical study.MethodsThis multicentre phase 3 clinical study included a 24-week, randomised, placebo-controlled, double-blind period followed by a 28-week open-label extended treatment period. Patients (N = 620) aged ≥18 and ≤75 years with glycated haemoglobin (HbA_1c) ≥7.0% and ≤10.5% [≥53.0 and ≤91.27 mmol/mol], were randomized in a 1:1 ratio to receive visepegenatide 150-μg or placebo once-weekly subcutaneous injection during the double-blind period. Subsequently, the patients in the placebo group were switched to visepegenatide treatment (placebo→visepegenatide group), and the patients in the visepegenatide group continued the same treatment during the open-label extended treatment period. The primary endpoint was the change in HbA_1c from baseline to week 24.FindingsAt week 24, the placebo-adjusted least squares mean (LSM) change of HbA_1c was -0.57% (95% CI -0.71 to -0.43) with visepegenatide (p < 0.001). The proportion of patients achieving HbA_1c < 7.0% and ≤6.5% [<53 and ≤ 48 mmol/mol] was higher in the visepegenatide group versus the placebo group (115 [40.5%] vs 50 [17.9%]; p < 0.001, and 60 [21.1%] vs 17 [6.1%]; p < 0.001). Visepegenatide demonstrated a significant reduction in fasting plasma glucose and 2-h postprandial glucose compared with placebo. Trends in the improvement of these variables were maintained during the open-label extended treatment period. No severe gastrointestinal adverse event or severe hypoglycaemia was reported during the 52-week study period.InterpretationOnce-weekly injection of visepegenatide 150 μg as an add-on treatment to metformin therapy significantly improved glycaemic control and was generally well tolerated in Chinese patients with T2DM who were inadequately controlled with metformin monotherapy.FundingThe study was funded by PegBio Co., Ltd, Suzhou, China.

2024-06-01·The Lancet Regional Health - Western Pacific

Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial

Article

作者: Ma, Jianhua ; Xu, Michael ; Liu, Li ; Jia, Ying ; Wang, Xuhong ; Li, Sheli ; Zhou, Zhiguang ; Yan, Xiang ; Zhu, Yikun ; Ding, Ke ; Liu, Jie ; Mo, Zhaohui ; Lin, Jingna ; Yan, Shuang ; Liu, Yan

BackgroundType 2 diabetes (T2DM) remains a challenge to treat despite the expansion of various therapeutic classes. Visepegenatide (PB-119) is a once a week, subcutaneous, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection without the requirement of dose titration that has shown glycaemic control and safety profile in two phase 2 studies conducted in China and the United States, respectively. The aim of this study was to evaluate the efficacy and safety of visepegenatide as a monotherapy in treatment-naïve patients with T2DM.MethodsThis was a multicentre, double-blind, parallel, placebo-controlled, phase 3 trial conducted in 30 centres in China. Adult participants (aged 18-75 years) with T2DM, glycated haemoglobin (HbA1c) of 7.5%-11.0% [58.47-96.73 mmol/mol], body mass index (BMI) of 18-40 kg/m², and who had been treated with diet and exercise alone for at least 8 weeks before the screening visit were eligible for enrolment. After a 4-week placebo injection run-in period, participants with HbA1c of 7.0%-10.5% [53.0-91.3 mmol/mol] and fasting plasma glucose (FPG) < 15 mmol/L were randomised in a ratio of 1:1 to receive visepegenatide (150 μg) or placebo subcutaneous injections once a week for 24 weeks. The treatment was extended to another 28 weeks during which all participants received visepegenatide. The primary outcome was a change in HbA1c from baseline to week 24. This study was registered with ClinicalTrials.gov, as NCT04504370.FindingsBetween November 2, 2020, and November 2, 2022, we randomly assigned 273 adult participants to the visepegenatide (n = 137) and placebo (n = 136) groups. In total, 257 (94.12%) participants, 131 (95.6%) on visepegenatide, and 126 (92.6%) on placebo, completed the double-blinded treatment period. At baseline, the mean (SD) HbA1c was 8.47% (0.81) [69.07 [8.81] mmol/mol], which rapidly decreased to 7.63% (0.80) [59.94 [8.70] mmol/mol] with visepegenatide by week 4 of treatment, and the change from baseline was significantly greater than that in the placebo group (-0.82% [-0.90 to -0.74]; [-8.99 [-9.89 to -8.10] mmol/mol] vs -0.30% [-0.41 to -0.19]; [-3.30 [-4.50 to -2.09] mmol/mol]). At week 24, when evaluating the effects of treatment with treatment policy estimand, the least square mean (LSM change in HbA1c from baseline was -1.36 (95% confidence interval [CI] -1.52 to -1.20) [-14.84 [-16.60 to -13.08] mmol/mol] in the visepegenatide group vs -0.63 (-0.79 to -0.46) [-6.84 [-8.61 to -5.07] mmol/mol] in the placebo group. The reduction in HbA1c was significantly greater with visepegenatide than placebo (LSM difference -0.73, 95% CI -0.96 to -0.50; p < 0.001). When evaluating the treatment estimand with hypothetic policy, the LSM change in HbA1c from baseline in the visepegenatide group (-1.37 [-1.53 to -1.20]) [-14.95 [-16.76 to -13.14] mmol/mol] was significantly greater than the placebo group (-0.63 [-0.81 to -0.45]) [6.90 (-8.89 to -4.90) mmol/mol]. The LSM difference was (-0.74, 95% CI -0.98 to -0.49; [-8.00 [-10.50 to -5.50] mmol/mol]; p < 0.001]. A significantly greater proportion of the visepegenatide group achieved a target HbA1c level of <7% (<53 mmol/mol) than the placebo (50.4% vs 14.2%; p < 0.05) and stringent HbA1c level of ≤6.5% (≤48 mmol/mol) (26.7% vs 7.9%), respectively. There was also a significantly greater improvement in FPG, 2-h postprandial glucose, homeostasis model assessment (HOMA) of beta cell function, post-prandial insulin, fasting, and post-prandial C-peptide level (p < 0.05) with visepegenatide treatment. The number (3 [2.2%]) of participants who received rescue therapy in the visepegenatide group was remarkably lower compared with those (17 [12.5%]) in the placebo group (p < 0.05). During the extended treatment period, visepegenatide consistently maintained the efficacy till week 52 confirmed by all the above endpoints. The reduction in HbA1c at week 52 was -1.39% (-1.58 to -1.19) [-15.14 [-17.28 to -13.01] mmol/mol], which was even greater than that at week 24. There was also a significant improvement in HOMA-insulin resistance (p = 0.004) at week 52 compared with the baseline value. For the placebo→visepegenatide group, which received visepegenatide in the extended treatment period, a notable decrease in HbA1c at week 52 compared to baseline was observed. The change from baseline in HbA1c was -1.49% (-1.68 to -1.30) [-16.27 [-18.37 to -14.16] mmol/mol]. The outcome was in the same direction as the visepegenatide group from the double-blind treatment period. Comprehensive benefits of visepegenatide including weight loss, improvement in lipid profile, and reduction in blood pressure have been demonstrated in this study. Visepegenatide reduced the body weight in a BMI-dependent manner that was prominent in BMI ˃32 kg/m² with a mean (SD) reduction of -4.77 (13.94) kg at week 52 (p < 0.05). Incidences of gastrointestinal adverse events were less common than other weekly GLP-1 RA in the market, and most of the adverse events were mild and moderate in nature, occurring in the first weeks of the treatment, and were transient. No serious hypoglycaemia or grade 2 hypoglycaemia (blood glucose: ≤3 mmol/L) was reported during the study.InterpretationAs a monotherapy, visepegenatide provided rapid without the risk of hypoglycaemia, significant, and sustainable glycaemic control by improving islet β-cell function and insulin resistance. Treatment with visepegenatide induced early treatment response in reducing HbA1c and maintaining glycaemic control for 52 weeks. Meanwhile, visepegenatide provided a comprehensive benefit in body weight loss, lipids, and blood pressure reduction. Visepegenatide had a better safety profile than other weekly GLP-1 RA in participants with T2DM even without the requirement of dose titration. Visepegenatide would provide an optimal treatment approach with its high benefit and low-risk balance.FundingPegBio Co., Ltd.

2021-05-01·Diabetologia1区 · 医学

Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study

1区 · 医学

Article

作者: Zhou, Haifeng ; Liu, Jie ; Qin, Guijun ; Li, Shiyun ; Ye, Shandong ; Geng, Houfa ; Du, Ying ; Chen, Lei ; Pang, Shuguang ; Du, Yinghong ; Ma, Jianhua ; Li, Jiarui ; Lv, Wenshan ; Xu, Min ; Song, Weihong ; Liu, Hui ; Zhou, Xiangjun ; Ran, Jianmin ; Ji, Linong ; Tan, Huiwen ; Guan, Qingbo ; Yao, Minxiu ; Li, Ping ; Shen, Feixia ; Lin, Jingna ; Wang, Yanjun ; Jiang, Xiaohong ; Jin, Hui ; Chen, Tao ; Li, Yufeng ; Li, Wenhui ; Mo, Zhaohui ; Yang, Jinkui ; Yang, Jing ; Lei, Minxiang

AbstractAims/hypothesisGlucagon-like peptide 1 receptor agonists (GLP-1 RA) such as exenatide are used as monotherapy and add-on therapy for maintaining glycaemic control in patients with type 2 diabetes mellitus. The current study investigated the safety and efficacy of once-weekly PB-119, a PEGylated exenatide injection, in treatment-naive patients with type 2 diabetes.MethodsIn this Phase II, randomised, placebo-controlled, double-blind study, we randomly assigned treatment-naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive subcutaneous placebo or one of three subcutaneous doses of PB-119 (75, 150, and 200 μg) for 12 weeks. The primary endpoint was the change in HbA1c from baseline to week 12, and other endpoints were fasting plasma glucose, 2 h postprandial glucose (PPG), and proportion of patients with HbA1c < 53 mmol/mol (<7.0%) and ≤48 mmol/mol (≤6.5%) at 2, 4, 8 and 12 weeks of treatment. Safety was assessed in all patients who received at least one dose of study drug.ResultsWe randomly assigned 251 patients to one of the four treatment groups (n = 62 in placebo and 63 each in PB-119 75 μg, 150 μg and 200 μg groups). At the end of 12 weeks, mean differences in HbA1c in the treatment groups were −7.76 mmol/mol (95% CI −9.23, −4.63, p < 0.001) (−0.72%, 95% CI −1.01, −0.43), −12.89 mmol/mol (95% CI −16.05, −9.72, p < 0.001) (−1.18%, 95% CI −1.47, −0.89) and −11.14 mmol/mol (95% CI −14.19, −7.97, p <0 .001) (−1.02%, 95% CI −1.30, −0.73) in the 75 μg, 150 μg and 200 μg PB-119 groups, respectively, compared with that in the placebo group after adjusting for baseline HbA1c. Similar results were also observed for other efficacy endpoints across different time points. There was no incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death.Conclusions/interpretationAll tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes.Trial registrationClinicalTrials.gov NCT03520972FundingThe study was funded by National Major Scientific and Technological Special Project for Significant New Drugs Development and PegBio.Graphical abstract

项与聚乙二醇化艾塞那肽相关的新闻（医药）

2025-05-02

·药融圈

多肽新药企业IPO在即，新药已经NDA（附材料）

▲8月1-2日 2025生物医药创新博览会扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融圈获悉：2025年4月25日，派格生物医药（杭州）股份有限公司 - B （以下简称：派格生物）通过中国香港港交所聆讯，派格生物已通过中国证监会IPO备案。2025年该公司将总部搬迁至杭州并更名为派格生物医药（杭州）股份有限公司，前称为派格生物医药（苏州）股份有限公司。派格生物，公司的核心产品PB-119为自主开发、潜在的接近商业化阶段的长效胰高血糖素样肽1（「 GLP-1」，一种降低血糖水平的肽类激素）受体激动剂。GLP-1受体激动剂是一种启动GLP-1受体的药剂，可模拟GLP-1的受体启动功能，主要包括促进胰岛素分泌、抑制胰高血糖素分泌、抑制胃肠蠕动和食欲、葡萄糖摄取和脂肪降解等功能。PB-119主要用於T2DM及肥胖症一线治疗。其已于多项临床试验中显示出在血糖控制、心血管健康等方面的多种益处，以及对体重管理的良好效果。长效GLP-1受体激动剂是指需要每週一次给药方案的产品，如PB-119，而短效GLP-1受体激动剂则需要每日一次或多次给药方案。PB-119在中国用于治疗T2DM的新药上市申请（「NDA」）于2023年9月获中国国家药监局（NMPA）受理。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据2023财年及2024财年，公司的除税前亏损分别为人民币2.79亿元及人民币2.83亿元。公司几乎所有亏损均来自研发开支及管理开支。公司的研发开支从2023年的人民币236.7百万元减少至2024年的人民币95.4百万元。该减少与核心产品由III期临床阶段推进至NDA备案阶段一致。产品线领域而言：临床阶段候选药物包括主要产品PB-718(用于减重及降低肝脏脂肪含量)、PB-1902(一款国内研发处于临床试验阶段的用于治疗阿片类药物引起的便秘的口服型候选药物)、PB-722(用于治疗先天性高胰岛素血症，获得FDA孤儿药资格认定)，以及临床前阶段产品PB-2301(用于治疗T2DM、NASH和肥胖症的潜在同类最佳GLP-1/葡萄糖依赖性促胰岛素多肽(GIP)双受体激动剂)、 PB-2309(用于治疗T2DM、NASH和肥胖症的潜在同类最佳GLP-1/GIP/GCG三受体激动剂)。从2008年至2023年，派格生物累计融资金额超过21亿元人民币，投资基金包括联想、云锋、君联、元生、建银等。2023年6月的F+轮融资后，派格生物估值达40亿元。附，分享：发送派格生物（请正确复制）至下方药融圈微信公众号后台可获得IPO PDF原文。仅供学习交流分享，不做投资建议！参考：NMPA/CDE；摩熵医药数据pharma.bcpmdata.com（原药融云数据）；FDA/EMA/PMDA；https://www.pegbio.com/；https://www1.hkexnews.hk/app/sehk/2024/106907/documents/sehk24111300081_c.pdf；等等。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐。更多药企信息交流或合作可后台留下名片。会议推荐 | 点击查看详情植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

临床3期孤儿药IPO申请上市财报

2025-04-28

·药研网

派格生物过港交所聆讯！40亿估值，GLP-1赛道新星崛起？

4月25日，派格生物医药（杭州）股份有限公司顺利通过香港联合交易所聆讯，计划发行不超过1.405亿股境外上市普通股，开启港股上市新征程，中金公司担任独家保荐人。值得注意的是，派格生物的IPO之路十分曲折。2021年8月，公司申请科创板上市，但经历两轮问询后撤单，考虑到联交所为获取外资及吸引多元化海外投资者提供的国际平台，随后便转战港交所。2024年2月，派格生物递表港交所，且已通过上市聆讯，但却迟迟未能上市，而后无疾而终。2024年11月，派格生物二次递表港交所，再次寻求上市。从2008年至2023年，派格生物共进行数轮融资，累计融资金额超过21亿元，投资方包括联想之星、君联资本、云锋基金、元生创投、建银国际等。截至2023年6月的F+轮融资后，派格生物估值达到40亿元。作为一家专注慢性病创新疗法的生物科技企业，派格生物自2008年成立以来，聚焦代谢疾病领域，尤其是核心产品长效GLP-1受体激动剂PB-119（维派那肽）的自主研发。PB-119，是一款用于2型糖尿病（T2DM）及肥胖症一线治疗的自主开发、接近商业化阶段的长效胰高血糖素样肽1（GLP-1）受体激动剂，在多项临床试验中显示出在血糖控制、心血管健康等方面的全面益处，以及对体重管理的良好效果。PB-119（visepegenatide/维派那肽）已于2023年获中国国家药监局受理新药上市申请，预计2025年一季度正式上市。图2：PB-119的作用机制除了PB-119，派格生物丰富的候选药物管线中还包括双受体激动剂PB-718、治疗阿片类药物引起便秘的PB-1902及具有孤儿药资格的PB-722等多款创新产品，覆盖范围拓展至NASH、体重管理及罕见代谢疾病。图3：派格生物在研管线2025年，体重管理被纳入国家公共卫生重点推动，市场空间广阔，未来或达数百亿元规模。End声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，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/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾1关张、破产、裁员 | 2024年生物药企的阴影2全球第一款司美格鲁肽咀嚼软糖上市！3中国首个男性HPV疫苗获批上市!

上市批准IPO孤儿药疫苗

2025-04-27

·医药魔方Invest

派格生物过聆讯，即将在港上市

—各奖项申报陆续启动，欢迎关注—4月25日，香港联合交易所官网显示，派格生物医药（杭州）股份有限公司（以下简称“派格生物”）通过联交所聆讯即将在港股上市，中金公司为独家保荐人。图片来源：联交所官网成立于2008年的派格生物是一家专注于自主研究及开发慢性病创新疗法（主要为肽和小分子药物）的生物技术公司，重点关代谢紊乱领域。招股书显示，派格生物已自主开发一款核心产品及其他五款候选产品，以把握2型糖尿病（「T2DM」）、肥胖症、非酒精性脂肪性肝炎（「NASH」）、阿片类药物引起的便秘（「OIC」，使用阿片类药物引起的胃肠道疾病）及先天性高胰岛素血症（一种罕见的内分泌疾病，患者持续出现低血糖症）等常见慢病及代谢疾病的市场机会。其核心产品PB-119为自主开发、接近商业化阶段的长效胰高血糖素样肽-1（「GLP-1」，一种降低血糖水平的肽类激素）受体激动剂。GLP-1受体激动剂是一种启动GLP-1受体的药剂，可模拟GLP-1的受体启动功能，主要包括促进胰岛素分泌、抑制胰高血糖素分泌、抑制胃肠蠕动和食欲、促进葡萄糖摄取和脂肪降解等功能。PB-119主要用于T2DM及肥胖症一线治疗，已在多项临床试验中显示出在血糖控制、心血管健康等方面的多种益处，以及对体重管理的良好效果。PB-119在中国用于治疗T2DM的新药上市申请（「NDA」）于2023年9月获国家药监局受理，这是其即将进行商业化的重要里程碑。派格生物管线图；来源：招股书派格生物的主要产品PB-718是一款双受体激动剂，可以同时激活GLP-1受体和胰高血糖素（「GCG」）受体。PB-718的创新设计使其成为派格生物管线中治疗肥胖症及NASH的重要候选药物。派格生物计划于2025年就PB-718的IIb期临床试验计划与国家药监局进行沟通；亦计划于2025年下半年向国家药监局提交IND申请，以在中国开展PB-718治疗NASH的II期临床试验。派格生物正在利用支持研发的自有核心技术平台高效靶点筛选及分子修饰剂平台（Highly Effective Target Screening & Molecule Modifier Platform，HECTOR®）开发产品管线。HECTOR®包括代谢疾病数据收集、药物分子设计平台及化合物筛选平台。招股书显示，派格生物自成立以来已完成九轮投资，所筹集的总金额约为50.3百万美元及人民币10.5亿元。截至最后实际可行日期，已动用投资所得款项的89.76%。其投资者包括Mingly、元生创投、True Wing、盈科PE、Nice Credit、凯风创业投资、天士力（香港）等。图片来源：招股书财务方面，于2023年及2024年，派格生物除税前亏损分别为人民币279.2百万元及人民币283.4百万元，其研发开支从2023年的人民币236.7百万元减少至2024年的人民币95.4百万元。图片来源：招股书派格生物单一最大股东集团由Michael Min XU博士、Xiangjun ZHOU博士、徐宇虹博士及上海苏颉组成。上述各方于2021年4月2日订立一致行动方协议（「一致行动方协议」）。上海苏颉的普通合伙人（即王小军女士）担任行政职务，已获该公司指定，且Michael Min XU博士对其行使重大影响。招股书显示，Michael Min XU博士，60岁，董事长、执行董事兼该公司总经理，主要负责该集团的总体战略规划、业务方向及运营管理。徐博士于Pan-Asia在2001年7月成立时创办该业务，并自2001年12月起担任Pan-Asia执行董事兼董事长，直至其于2023年5月注销登记为止。徐博士亦分别自2021年2月、2021年2月及2025年1月起担任上海瀚迈、上海迈迹及苏州派格的执行董事。徐博士在医疗保健行业拥有逾30年的工作及管理经验。于创立该集团前，徐博士于1986年9月至1988年5月担任湘雅医学院第二附属医院眼科医生；于1992年至1996年，其担任哥伦比亚大学医学院生理学与细胞生物物理系分子识别中心研究员。自2014年8月至2022年7月，徐博士担任Crossbay Life Science Technologies Inc.的执行董事。自2019年8月起担任开拓药业有限公司独立非执行董事。徐博士于1986年7月获得中国湖南医科大学（现称中南大学湘雅医学院）医学学士学位，并于1996年2月获得美国纽约市哥伦比亚大学生物物理学博士学位。王小军女士，57岁，为该公司执行董事兼财务总监，主要负责该集团的总体战略规划、财务管理及财务报告。王女士于2008年7月至2020年12月担任该公司财务经理，于2008年5月至2019年7月担任监事，并于2020年12月至2023年5月担任董事会秘书。加入该集团前，王女士于上世纪九十年代从事财务会计工作。王女士于2003年7月获得中国中央广播电视大学会计学学士学位，并于2018年6月获得中国上海国家会计学院会计学硕士学位。王女士于1998年5月获中华人民共和国人事部（现称为中华人民共和国人力资源和社会保障部）授予会计师资格。推荐阅读营收净利双增超20%，恒瑞一季报何以超预期？华东最大民营营利性综合医院集团过港交所聆讯，即将上市Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床申请临床2期申请上市临床1期

100 项与聚乙二醇化艾塞那肽相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	申请上市	中国	派格生物医药（苏州）股份有限公司	2023-09-26
肥胖	临床2期	中国	派格生物医药（苏州）股份有限公司	2024-05-27
超重	临床申请	-	派格生物医药（苏州）股份有限公司	-
阿尔茨海默症	临床前	美国	派格生物医药（苏州）股份有限公司	2023-09-27

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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


NCT03062774 (Pubmed \| Eur J Drug Metab Pharmacokinet) 人工标引	临床1期	-	36	PB-119	(醖範鏇艱壓淵襯鑰餘鹹) = 憲製鹽觸鑰獵淵鹹醖獵簾積蓋顧餘鹽鬱製願遞 (壓繭顧選構獵觸鹽構觸 ) 更多	积极	2021-03-01
NCT02084251 (Pubmed \| Eur J Drug Metab Pharmacokinet) 人工标引	临床1期	-	70	PB-119	(艱衊齋醖簾觸鬱願獵網) = Several subjects in the 100-µg and 200-µg groups had tolerable gastrointestinal tract reactions, and all subjects in the 400-µg group experienced adverse reactions, mainly gastrointestinal tract reactions and liver dysfunction. 夢膚壓鹹構壓醖淵繭範 (膚鏇築遞繭夢積觸構積 )	积极	2020-06-01
NCT02084251 (Pubmed \| Eur J Drug Metab Pharmacokinet) 人工标引	临床1期	-	70	Placebo		积极	2020-06-01