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]

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]

ChiCTR2100052484

/ Recruiting临床1期IIT

To evaluate the exploratory clinical study of all human anti-PD-L1 antibody injection (LDP) combined with recombinant anti EGFR human mouse chimeric monoclonal antibody injection (cdp1) in patients with advanced malignant tumors

开始日期2021-01-02

申办/合作机构

宝船生物医药科技（上海）有限公司

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) 相关的专利（医药）

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188

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2026-02-01·Neurology and Therapy

Foslevodopa/Foscarbidopa in Younger Patients Earlier Within Advanced Parkinson’s Disease: Post Hoc Analysis of a Randomized Trial

Article

作者: Standaert, David G ; Antonini, Angelo ; Gandor, Florin ; Bergmans, Bruno ; Kimber, Thomas ; Bergmann, Lars ; Gupta, Resmi ; Kern, Drew S ; Nozaki, Toshiki ; Fritz, Bjoern ; Nishikawa, Noriko ; Shah, Megha B

INTRODUCTION:

We evaluated continuous subcutaneously administered foslevodopa/foscarbidopa (LDp/CDp) in younger patients earlier within advanced Parkinson's disease (aPD).

METHODS:

This phase 3 trial included patients aged ≥ 30 years with levodopa-responsive PD, Mini-Mental State Examination score ≥ 24, and levodopa equivalent dose ≥ 400 mg/day. Patients were considered by the investigator as inadequately controlled on current oral/transdermal therapy and experienced ≥ 2.5 h/day "Off" time, with recognizable "On"/"Off" states. Patients were randomized (1:1) to LDp/CDp plus placebo capsules or orally administered immediate-release levodopa/carbidopa plus placebo infusion. This post hoc exploratory analysis focused on younger patients (≤ 65 years) earlier within aPD (Hoehn and Yahr stage ≤ 2 ["On" state], ≤ 5 years since motor fluctuations started). Outcomes included change from baseline (CFB) to week 12 in "Off" and "On" time, Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) II, 39-item PD Questionnaire (PDQ-39), and PD Sleep Scale-2 (PDSS-2).

RESULTS:

Twenty-six patients met subgroup criteria (LDp/CDp, n = 13; orally administered levodopa/carbidopa, n = 13). Despite small sample sizes, at week 12, LDp/CDp was associated with significantly greater improvements in "Off" time (mean [SD] CFB - 3.7 [3.1] vs - 1.6 [2.9] h; P = 0.0011), "On" time without troublesome dyskinesia (+ 3.9 [3.3] vs + 1.4 [3.8] h; P = 0.0011), and PDSS-2 (- 6.4 [4.6] vs - 1.8 [3.1]; P = 0.0220) vs orally administered levodopa/carbidopa. Mean (SD) CFB to week 12 (LDp/CDp vs orally administered levodopa/carbidopa) was + 4.2 (2.8) vs + 1.9 (4.6) h for "On" time without dyskinesia (P = 0.0878), - 3.0 (6.4) vs - 0.9 (3.5) for MDS-UPDRS II (P = 0.3539), and - 9.9 (7.4) vs - 1.9 (9.4) for PDQ-39 (P = 0.0534). For most assessments, treatment differences were numerically larger in the subgroup vs the overall population. Safety findings were consistent with the overall population.

CONCLUSIONS:

LDp/CDp was associated with significantly greater improvements in motor function and sleep vs orally administered levodopa/carbidopa in younger patients earlier within aPD whose symptoms were inadequately controlled by oral/transdermal therapies. Larger real-world studies are needed to confirm findings.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT04380142.

2026-01-01·Movement Disorders Clinical Practice

Efficacy and Safety of Foslevodopa/Foscarbidopa Monotherapy in Patients with Parkinson's Disease

Article

作者: Megha B. Shah PharmD ; Manon Bouchard MD ; Jason Aldred MD ; David G. Standaert MD, PhD ; Pavnit Kukreja PharmD ; Resmi Gupta PhD ; Tove Henriksen MD ; Juan Carlos Martínez-Castrillo MD, PhD ; Michael J. Soileau MD ; Stuart H. Isaacson MD ; Amy M. Spiegel PhD ; Lars Bergmann MD

Abstract:

Background:

As Parkinson's disease (PD) progresses, managing symptoms becomes increasingly difficult. Foslevodopa/foscarbidopa (LDp/CDp), a 24‐hour/day continuous subcutaneous infusion of levodopa/carbidopa (LD/CD) prodrugs, improves motor complications. The feasibility and sustainability of LDp/CDp monotherapy warrants investigation.

Objective:

The aim was to report the efficacy and safety of LDp/CDp monotherapy and combination therapy.

Methods:

This post hoc analysis assessed patients with PD and ≥2.5 “Off” hours/day receiving LDp/CDp monotherapy or combination therapy in 3 trials: a 12‐week randomized active‐controlled trial (RCT) comparing LDp/CDp with oral immediate‐release LD/CD (NCT04380142), a 52‐week open‐label trial of LDp/CDp (NCT03781167), and its 96‐week open‐label extension study (OLE; NCT04379050). Monotherapy was defined as receiving LDp/CDp without concomitant PD medications; combination therapy was defined as receiving LDp/CDp with other PD medications.

Results:

In the RCT, 74 of 141 patients received LDp/CDp. The 52‐week trial enrolled 244 patients; 129 entered the OLE. Of LDp/CDp‐treated patients, 19 of 74 (25.7%) in the RCT, 49 of 244 (20.1%) in the 52‐week trial, and 46 of 129 (35.7%) in the OLE received monotherapy. In the RCT, mean (standard deviation) change from baseline to week 12 in “Off” time was −4.5 (4.4) and −3.0 (3.5) hours for monotherapy and combination therapy, respectively; +4.1 (3.7) and +3.1 (3.6) hours for “On” time without troublesome dyskinesia; and +4.0 (3.6) and +4.0 (3.9) hours for “On” time without dyskinesia. Efficacy was similar in open‐label trials. Improvements in the Movement Disorder Society‐Unified Parkinson's Disease Rating Scale Part II, 39‐item Parkinson's Disease Questionnaire, Parkinson's Disease Sleep Scale‐2 scores, and overall safety were comparable between monotherapy and combination therapy groups.

Conclusions:

LDp/CDp monotherapy treatment may be suitable for up to 96 weeks.

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.

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

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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	桂林三金药业股份有限公司	2019-05-30
晚期癌症	临床1期	中国	天演药业（苏州）有限公司	2019-05-30