重组全人源抗PD-L1抗体 (桂林三金药业)(Recombinant human anti-PD-L1 monoclonal antibody(Guilin Sanjin Pharmaceutical Co., Ltd.)) - 药物靶点：PDL1_在研适应症：肾肿瘤，肌层浸润性膀胱癌，阴茎肿瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

LDP、lesabelimab、ADG104

+ [1]

靶点

PDL1

作用方式

抑制剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

权益机构

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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结构/序列

Sequence Code 631426828H

来源: *****

Sequence Code 631426829L

来源: *****

关联

5

项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的临床试验

NCT04739111

/ Unknown status临床1期

An Exploratory Clinical Study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined With Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Malignant Tumor

This is an exploratory clinical study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in patients with advanced malignant tumor.

开始日期2021-01-29

申办/合作机构

宝船生物医药科技（上海）有限公司

[+1]

CTR20202642

/ Active, not recruiting临床1期

评价全人源抗PD -L1抗体注射液（LDP）联合重组抗EGFR人鼠嵌合单克隆抗体注射液（CDP1）在晚期恶性肿瘤患者中的探索性临床研究

评估LDP联合CDP1治疗晚期恶性肿瘤患者的安全性，确定临床试验推荐剂量。

开始日期2021-01-20

申办/合作机构

宝船生物医药科技（上海）有限公司

CTR20201949

/ Active, not recruiting临床2期

全人源抗PD-L1抗体注射液（LDP）治疗泌尿及男性生殖系统肿瘤有效性和安全性的、单臂、开放、多中心、II期临床研究

评价全人源抗PD-L1抗体注射液（LDP）在肌层浸润性膀胱癌新辅助、晚期非透明细胞肾癌和晚期阴茎癌受试者中的有效性和安全性。

开始日期2021-01-07

申办/合作机构

桂林三金药业股份有限公司

[+3]

100 项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的临床结果

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100 项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的转化医学

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100 项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的专利（医药）

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217

项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Foslevodopa/foscarbidopa (LDp/CDp) in advanced Parkinson’s disease (aPD): demonstration of savings from a societal perspective in the UK

Article

作者: Boodhna, Trishal ; Bergmann, Lars ; Chaudhuri, K. Ray ; Leoncini, Emanuele ; Belsey, Jonathan

AIMS:

In advanced Parkinson's disease (aPD), adequate 24-hour control of OFF-time may not be achievable using oral/transdermal therapies. Clinical trials of foslevodopa/foscarbidopa (LDp/CDP) demonstrate meaningful reductions in OFF-time and OFF-related sleep disturbance in aPD. Previous analyses have only considered direct medical costs: this analysis considers a broader societal perspective (direct non-medical costs, informal care, loss of earnings, productivity, and tax).

METHODS:

Inputs for the societal impact model were taken from a cost-utility model comparing LDp/CDp with best medical treatment (BMT), accepted by the UK National Institute of Health and Care Excellence (NICE). Quintiles of normalized OFF-time across a 16-hour waking day in each treatment group were applied to literature-based estimates for direct medical, non-medical, and indirect costs. The resulting state-specific cost estimates were applied to the modelled aPD patient population.

RESULTS:

The model estimates the potential UK population for LDp/CDp at 17,505. Continuous 24-hour delivery of LDp/CDp results in greater time spent in OFF-time states 0-1 (0-4 h of OFF-time/16-hour waking day) vs BMT alone. Net costs in year 1, if all eligible patients receive LDp/CDp, are £45.5 M. Cumulative net savings thereafter are £47.0 M by year 2, rising to £166.1 M by year 3, £261.9 M by year 4 and £312.2 M by year 5. Results are robust in scenario analyses (excluding costs of sleep disturbance, earnings loss, productivity, and tax loss).

LIMITATIONS:

A NICE-accepted model was used as the economic modelling basis for the societal impact model. However, much of the data was derived from Adelphi datasets, with the potential for inconsistent definitions.

CONCLUSION:

When considered from a societal perspective, the use of LDp/CDp in aPD patients inadequately controlled on oral therapy, is associated with a reduction in medium-term healthcare and societal costs vs BMT.

2025-12-01·JOURNAL OF MEDICAL ECONOMICS

Statement of Retraction: Foslevodopa/foscarbidopa (LDp/CDp) in advanced Parkinson's Disease (aPD): demonstration of savings from a societal perspective in the UK.

Article

2025-10-01·NEUROSCIENCE LETTERS

Paeonol facilitates the repair of neuronal damage in the mPFC caused by chronic stress via the Rho GTPases-cofilin1 signaling pathway

Article

作者: Li, Qiang ; Xu, Zhiliang ; Meng, Kang ; Yan, Xili ; Shi, Liangbin ; Zhang, Yegui ; Zhu, Xiuling ; Zong, Yongli ; Zhao, Yingdi ; Sun, Zihang

BACKGROUND:

The Rho GTPases-cofilin1 signalling axis preserves neuronal morphology and synaptic plasticity by modulating actin homeostasis. However, the potential role of paeonol-a bioactive compound derived from Paeonia suffruticosa-in mitigating CUMS-induced neuronal injury via this pathway remains unelucidated.

OBJECTIVE:

This study investigates the neuroprotective mechanisms of paeonol against CUMS-associated neuronal injury in the medial prefrontal cortex (mPFC), focusing on the Rho GTPases-cofilin1 signalling axis.

METHODS:

60 male Sprague-Dawley rats were divided into five groups: Control, CUMS, Fluoxetine-treated (Flu), low-dose paeonol (LDP, 25 mg/kg), and high-dose paeonol (HDP, 80 mg/kg). Depressive-like phenotypes were induced via a 4-week CUMS paradigm, followed by daily gavage of fluoxetine or paeonol. Behavioral assessments quantified depressive-like phenotypes. Histology used HE and Nissl staining; dendritic morphology was assessed via Golgi impregnation. Protein levels of Rac1, Cdc42, RhoA, Cofilin1, and p-Cofilin1 in mPFC were quantified by Western blot.

RESULTS:

CUMS-exposed rats displayed prolonged immobility duration and delayed feeding initiation; paeonol and fluoxetine attenuated these deficits. Golgi analysis showed CUMS reduced total dendritic length, apical dendrite extension, branching complexity and mature dendritic spines (mushroom/branched), while increasing filopodial protrusions in mPFC pyramidal neurons. Both treatments rescued these alterations. Western blot showed CUMS decreased p-cofilin1 levels and downregulated Rac1 and Cdc42 expression, while increasing cofilin1. Paeonol normalized p-cofilin1 phosphorylation, restored Rac1 and Cdc42 expression and reduced cofilin1 levels.

CONCLUSION:

Paeonol alleviates CUMS-induced behavioural impairments, potentially through modulating the Rho GTPases-cofilin1 signaling axis.

1

项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的新闻（医药）

2021-01-21

·医药合作投融资联盟

重磅！天演药业提交美股IPO申请，拟募资1.25亿美元

2021年1月19日，据美国纳斯达克官网显示，正在中国开发抗体癌症免疫疗法的Adagene（天演药业）向美国证券交易委员会提交了F-1申请，希望通过首次公开募股筹集至多1.25亿美元（F-1文件例行融资规模不代表实际募资金额）。联席承销商是高盛、摩根士丹利，Jefferies，华兴资本。天演药业2014年成立至今已经累计融资超过1.5亿美元，其中包括2018年3月完成了5000万美元C轮融资，2020年1月完成了6900万美元D轮融资，猜测估值5亿美元左右。天演药业目前合作伙伴有药明生物、宝船生物、ADC Therapeutics 、Sanjin等。这是今年继亘喜生物在美股IPO上市后，拓臻生物提交IPO申请（8700万美元融资后，拓臻生物提交美股IPO申请，拟募资1亿美元！）后第三家来自中国的biotech去纳斯达克上市申请。 Adagene（天演药业）投资机构在将计算生物学和人工智能相结合的强大平台的驱动下，该公司的AI-Powered DPL平台探索了蛋白质序列的动态构象多样性，尤其是抗体序列的灵活结合位点，以此作为发现抗体药物的新范例。动态精密库平台由三种专有技术组成，这些专有技术针对基于抗体的治疗方式的三个关键属性进行了定制： NEObody™可以生成具有动态结合位点的抗体，这些结合位点通过新型MOA（称为NEO抗体）在动力学上适应独特的表位。 SAFEbody™能够生成被掩盖的抗体和NEO抗体，这些抗体和NEO抗体被设计为在肿瘤微环境或TME中选择性激活，从而有可能限制正常组织中的靶标非肿瘤毒性，称之为SAFE抗体。 POWERbody™将我们的SAFEbody技术应用于强大的基于抗体的模式，例如创建新的SAFE双特异性T细胞衔接子，SAFE抗体-药物偶联物或SAFE ADC或旨在超越传统单特异性抗体治疗功效的抗体。 Notes: 1 NEO, SAFE and POWER refer to the NEObodyTM, SAFEbodyTM and POWERbodyTM respectively* The ADG104 Phase Ib/II clinical trial is conducted by our partner, Sanjin Adagene专门构建的技术平台已经产生了潜在的具有独特MOA的一流产品管线。 ADG106：领先的NEObody™项目是CD137的一流，安全和有效的激动剂，正在对晚期/转移性实体瘤患者进行评估。 ADG126：领先的SAFEbody™项目针对CTLA4，并且在临床前研究中显示，与常用的CTLA4癌症疗法相比，该疗法更安全，更有效，更持久。 ADG116：第二项NEObody项目针对CTLA4的独特表位，目前正在对患有晚期/转移性实体瘤和/或复发/难治性非霍奇金淋巴瘤的患者进行评估。其最先进的NEObody产品候选物ADG106是目前在美国和中国正在进行I期试验的完全人配体阻断激动性抗CD137单克隆抗体。根据新闻来源，ADG106设计用于靶向CD137的独特表位，该表位与临床开发中的其他抗CD137抗体不同。天演药业部分管理团队（来源于官网）版权声明：本文转自医药合作投融资联盟，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈围绕我国生物医药产业链，针对生物医药大数据、技术和资本投资、药融园(产业园)等开展系列系统性工作，促进我国生物医药产业健康发展，完善产业链，共同面对全球合作和竞争。点分享点点赞点在看

抗体免疫疗法合作抗体药物偶联物IPO

100 项与重组全人源抗PD-L1抗体 (桂林三金药业) 相关的药物交易

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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
肾肿瘤	临床2期	中国	天演药业（苏州）有限公司	2021-01-07
肾肿瘤	临床2期	中国	桂林三金药业股份有限公司	2021-01-07
肌层浸润性膀胱癌	临床2期	中国	天演药业（苏州）有限公司	2021-01-07
肌层浸润性膀胱癌	临床2期	中国	桂林三金药业股份有限公司	2021-01-07
阴茎肿瘤	临床2期	中国	桂林三金药业股份有限公司	2021-01-07
阴茎肿瘤	临床2期	中国	天演药业（苏州）有限公司	2021-01-07
晚期肾细胞癌	临床2期	中国	宝船生物医药科技（上海）有限公司	2020-09-11
浸润性膀胱癌	临床2期	中国	宝船生物医药科技（上海）有限公司	2020-09-11
晚期癌症	临床1期	中国	天演药业（苏州）有限公司	2019-05-30
晚期癌症	临床1期	中国	桂林三金药业股份有限公司	2019-05-30