排名前五的靶点	数量

SCNA(电压门控钠通道α亚基家族)	3
COXs(环氧化酶)	3
RANKL(肿瘤坏死因子配体超家族成员11)	2
mAChRs(毒蕈碱型乙酰胆碱受体家族)	2
CSF-3R(巨噬细胞集落刺激因子3受体)	2

关联

项与 Fresenius SE & Co. KGaA 相关的药物

Sodium Glycerophosphate

甘油磷酸钠

靶点-

作用机制-

在研机构

费森尤斯卡比华瑞制药有限公司 [+1]

原研机构

费森尤斯卡比华瑞制药有限公司

在研适应症

营养不良

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

澳大利亚

首次获批日期2019-11-14

Potassium Phosphate, Dibasic/Potassium Phosphate, Monobasic

磷酸二氢钾/磷酸氢二钾

靶点-

作用机制-

在研机构

Amneal EU Ltd. [+1]

原研机构

Cmp Development Sdn. Bhd.

在研适应症

低磷血症

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2019-09-19

Multi-oil Fat Emulsion

多种油脂肪乳（C6-24）

靶点-

作用机制-

在研机构

Fresenius Kabi Austria GmbH

原研机构

Fresenius Kabi Austria GmbH

在研适应症-

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2017-01-01

202

项与 Fresenius SE & Co. KGaA 相关的临床试验

NCT06687369

/ Recruiting临床3期

Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)

This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.

开始日期2024-12-30

申办/合作机构

mAbxience Research SL

NCT06274788

/ RecruitingN/A

Title: A Single-arm, Open-label, Prospective, Multicenter Safety Study to Evaluate the Occurrence of Essential Fatty Acid Deficiency (EFAD) in Pediatric Patients With Parenteral Nutrition-associated Cholestasis (PNAC) Who Require More Than Eight Weeks of Omegaven Treatment

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

开始日期2024-12-15

申办/合作机构

Fresenius Kabi USA LLC

DRKS00023693

/ SuspendedN/A

Long-term outcome after different reconstructive techniques in patients with female genital mutilation

开始日期2024-11-05

申办/合作机构

HELIOS Klinikum Emil von Behring GmbH

100 项与 Fresenius SE & Co. KGaA 相关的临床结果

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0 项与 Fresenius SE & Co. KGaA 相关的专利（医药）

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1,788

项与 Fresenius SE & Co. KGaA 相关的文献（医药）

2025-12-31·COPD-Journal of Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Lung Volume Reduction with Endobronchial Coil #2 and Coil #4 Results of the German Emphysema Registry—Lungenemphysemregister e.V.

Article

作者: Stanzel, Franz ; Sgarbossa, Thomas ; Wiesemann, Björn ; Geltner, Christian ; Eisenmann, Stephan ; Grah, Christian ; Barten-Neiner, Grit ; Krist, Joanna ; Fertl, Andreas ; Schmidt, Bernd ; Becke, Birgit ; Wüstefeld, Hannah ; Hübner, Ralf-Harto ; Schwick, Björn ; Oei, Shiao Li ; Blazejczyk, Katarzyna ; Franke, Karl-Josef

BACKGROUND:

Clinical trials have shown beneficial results from lung volume reduction with endobronchial coils in patients with emphysema, but comprehensive safety data are not yet available for a new coil type, Coil #4. The objective of this study is to generate real-world data (RWD) on the safety and efficacy of endobronchial Coil #2 and Coil #4.

METHODS:

This is a cohort study of prospectively collected data from the multicenter German Lung Emphysema Registry e.V. (LE-Registry) for patients with advanced lung emphysema undergoing lung volume reduction. All patients treated with Coil #2 or Coil #4 were evaluated at baseline and at 3 months for pulmonary function tests (FEV₁, FVC, RV, DLCO, pCO₂), exercise capacity, quality of life (mMRC, CAT, SGRQ), and adverse events. Descriptive statistics were used to analyze response rates and changes in clinical outcomes.

RESULTS:

Data from 73 patients (37 Coil #2, 36 Coil #4) enrolled between 2017 and 2024 were evaluated. At 3 months, outcome data were available for 32 Coil #2 and 26 Coil #4 patients. In the Coil #2 cohort significant improvements in RV and SGRQ were observed. The Coil #4 cohort shows significant improvements in FVC, RV, SGRQ, and CAT. Complications occurred in 37% of Coil #2 and 37% of Coil #4 patients, with 26% of patients treated with Coil #4 experiencing pneumothorax.

CONCLUSIONS:

The outcomes observed in this RWD study are consistent with other published coil studies. The higher pneumothorax rate with Coil #4 is surprising and should be minimized by adapting the technique.

TRIAL REGISTRATION:

DRKS00021207 registered on 29/05/2020.

2025-12-01·Systems Biology in Reproductive Medicine

Investigation of testis proteome alterations associated with male infertility in Dcaf17-deficient mice.

Article

作者: Mistry, Bhavesh ; Abu-Dawud, Raed ; Shinwari, Zakia ; Almohanna, Falah ; Kashir, Junaid ; Alharbi, Thuraya ; Alanazi, Maha ; Alyacoub, Nadya ; Alaiya, Ayodele ; Colak, Dilek ; Ahmed, Hala ; Assiri, Abdullah ; Rajab, Mohamed

Disruption of Dcaf17 in mice resulted in male infertility with severe spermatogenesis defects. To investigate the molecular basis of infertility phenotype, we examined testicular proteomes of wild-type (WT) and Dcaf17^-/- mice using a mass spectrometry-based approach. We identified 727 and 525 differentially expressed proteins (DEPs) in 3- and 8-week old testes of Dcaf17^-/- mice, respectively, with an adjusted p-value cut-off of ≤ 0.05. Among these, 299 and 298 DEPs had fold change of ≥ 1.5 between WT and Dcaf17^-/- testes at -3- and 8-week old, respectively. In the 3-week old Dcaf17^-/- testes, 59.5% of the DEPs were up-regulated, while 40.5% were down-regulated. Similarly, in the 8-week old Dcaf17^-/- testes, 83.9% and 16.1% DEPs were up-regulated and down-regulated, respectively. Functional annotation and network analyses highlighted that many DEPs were associated with key biological processes, including ubiquitination, RNA processing, translation, protein folding, protein stabilization, metabolic processes, oxidation-reduction processes and sper-matogenesis. Subsequent immunohistochemistry and immunoblotting analyses showed higher ubiquitin levels in Dcaf17^-/- testes compared to WT, suggesting potential impairment in ubiquitin proteasome system (UPS) due to DCAF17 loss of function. Our data provide a basis for further work to elucidate the molecular function(s) of DCAF17 in spermatogenesis and male fertility.

2025-11-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Time-to-event analysis of the long-term outcome in trials comparing transcatheter and surgical aortic valve implantation: A meta-analysis.

Review

作者: Musumeci, Francesco ; Marin-Cuartas, Mateo ; Pollari, Francesco ; Kaul, Sanjay ; Dayan, Victor ; de la Cuesta, Manuela ; Verhoye, Jean-Philippe ; Boden, William E ; Brophy, James M ; Almeida, Rui M S ; Roda, Jorge R ; De Caterina, Raffaele ; Anselmi, Amedeo ; Barili, Fabio ; Papatheodorou, Stefania ; Parolari, Alessandro ; Tomasi, Jacques ; Mandrola, John ; Uva, Miguel Sousa

OBJECTIVE:

Indications for TAVI have been widened, although long-term device efficacy is still unclear. We aimed to compare the effectiveness of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) on a composite of death from any cause or stroke at 5-year follow-up according to risk profiles.

METHODS:

We performed a systematic literature review for randomized control trials (RCTs) comparing TAVI or SAVR. The primary endpoint was the composite of all-cause mortality or stroke at follow-up. Hazard ratios (HRs) and restricted mean survival time (RMST) differences within high, intermediate and low-risk profiles were estimated by reconstructing time-to-event data from these Kaplan-Meier curves.

RESULTS:

Eight trials were included (9811 participants). The incidence of composite endpoint increased concordantly with higher baseline risk profiles for both treatments. A time-variant effect was present with transcatheter superior to surgery early, as supported by a cumulative additional time-to-event of 0.77 months at 4 years driven by the high-risk group that is attenuated at 60 months. The benefit of the transcatheter approach increased over time up to 5 years in high-risk patients (RMST difference = 2.39; 95 %CI = -0.23;5.02; p-value = 0.07), while the benefit of the transcatheter approach in intermediate and low-risk patients showed a quadratic association with a smaller increase and attenuation of the observed benefit after 60 months postintervention (low-risk = 0.86; 95 %CI = -0.11,1.84; p-value 0.09; intermediate = 0.45; 95 %CI = -0.66;1.56; p-value = 0.42).

CONCLUSIONS:

Although an initial benefit of TAVI over SAVR, there are no significant differences at 5 years follow-up independently from the risk profile.

586

项与 Fresenius SE & Co. KGaA 相关的新闻（医药）

2025-09-08

·Fresenius

Fresenius receives a €400 million EIB loan to support R&D, innovation and capacity expansion across the EU

Sara Hennicken, Chief Financial Officer of Fresenius, and Nicola Beer, Vice President of the EIB, signed the loan agreement in Bad Homburg v.d.H., Germany. Download Image (JPG 20.65 MB) Contact Timo Lindemann T +49 (0) 6172 608-7939 timo.lindemann@fresenius.com Documents Text as PDF document (PDF, 114 KB) The European Investment Bank (EIB) loan of €400 million will support Fresenius investments to increase availability of innovative medicines and biosimilars across Europe. The loan demonstrates EIB’s ongoing commitment to high-quality and affordable healthcare. This financing is a further step in the #FutureFresenius agenda. Fresenius, a global healthcare company, will receive a new €400 million loan from the European Investment Bank (EIB) to strengthen Fresenius’ European research and development (R&D) activities. The financing will be used to support expansion of Fresenius Kabi's manufacturing of medical products and biosimilars in European countries. The EIB-backed investments aim to strengthen resilience of pharmaceutical production in the EU and contribute to security of supply and financial relief for European healthcare systems. This will facilitate access to modern and affordable healthcare. Sara Hennicken, CFO of Fresenius: "Our mission at Fresenius is to save and improve people’s lives. Investing in our core business with the development of innovative, affordable healthcare products is a key element of Rejuvenate, the current phase of our #FutureFresenius journey. Consequently, the continued trust of the European Investment Bank means more to us than just attractive financing; it is a valued recognition of our contribution to a healthy European future." Nicola Beer, Vice President of the EIB: “Our long-standing partnership with Fresenius is a testament to the EIB’s enduring commitment to accessible, high-quality healthcare throughout Europe. By supporting the accelerated development of biosimilar and generic pharmaceuticals by Fresenius across several European countries, we are helping to deliver innovative, affordable solutions for millions of patients while strengthening the EU’s resilience in medicine supply and research excellence. Together, we are scaling up scientific advances and manufacturing capability, paving the way for a healthier, more sustainable future.” Generic drugs account for around 70% of prescriptions in Europe but represent only just under 20% of pharmaceutical costs, according to an IQVIA research. As a manufacturer of pharmaceuticals, biosimilars, clinical nutrition and medical technologies with around 20 manufacturing plants and multiple R&D centers across Europe, Fresenius stands for the reliable supply of essential medicines. Over the last 5 years, Fresenius has invested more than €1 billion in European manufacturing in key markets. These investments are intended to meet European demand. The aim of Fresenius' local-for-local strategy is to manufacture products for European patients in Europe. Over the last 5 years, the EIB has provided more than €22 billion in financing for the health and life sciences sector, including €4 billion in countries outside the EU. The EIB has backed long term innovation investments by Fresenius for around 20 years. About the EIB The European Investment Bank (ElB) is the long-term lending institution of the European Union, owned by its Member States. Built around eight core priorities, we finance investments that contribute to EU policy objectives by bolstering climate action and the environment, digitalisation and technological innovation, security and defence, cohesion, agriculture and bioeconomy, social infrastructure, the capital markets union, and a stronger Europe in a more peaceful and prosperous world. The EIB Group, which also includes the European Investment Fund (EIF), signed nearly €89 billion in new financing for over 900 high-impact projects in 2024, boosting Europe’s competitiveness and security. All projects financed by the EIB Group are in line with the Paris Climate Agreement, as pledged in our Climate Bank Roadmap. Almost 60% of the EIB Group’s annual financing supports projects directly contributing to climate change mitigation, adaptation, and a healthier environment. Fostering market integration and mobilising investment, the Group supported a record of over €100 billion in new investment for Europe’s energy security in 2024 and mobilised €110 billion in growth capital for startups, scale-ups and European pioneers. Approximately half of the EIB's financing within the European Union is directed towards cohesion regions, where per capita income is lower than the EU average.

2025-09-02

·医药经济报

百济A股市值突破5千亿，复星地舒单抗在美获批，科奕纳米双抗ADC出海

1 百济神州A股总市值首次突破5千亿元 9月2日，百济神州A股股价低开高走，盘中一度涨逾15%，股价最高触及346元/股，创下历史新高。在股价推动下，百济神州总市值首次站上5千亿元高峰，成为A股目前市值最高的医药股。值得一提的是，2025年以来，百济神州A股股价已经实现翻倍式增长。 2025年上半年，百济神州实现营业收入175.2亿元，同比增加46.03%；营业利润达7.99亿元，归母净利润达4.5亿元，较上年同期均实现扭亏为盈。根据半年报，百济神州实现盈利主要是由于产品收入的大幅增长。报告期内，百济神州产品收入达173.60亿元，同比增长45.8%。其中，BTK抑制剂泽布替尼上半年全球销售额达125.27亿元，同比增长56.2%；PD-1抑制剂替雷利珠单抗上半年的销售额达26.43亿元，同比增长20.6%。在半年报中，百济神州也上调了2025年全年总收入指引至50亿美元至53亿美元，其中包括收入强劲增长的预期，受益于泽布替尼在美国的领先地位以及在欧洲和全球其他重要市场的持续扩张。 2 复星医药地舒单抗在美国获批上市 9月2日，复星医药发布公告称，其控股子公司复宏汉霖自主研发的 60 mg/mL、120 mg/1.7mL 两项规格的地舒单抗注射液（项目代号：HLX14）的生物制品许可申请（BLA）获美国FDA批准上市。HLX14为复宏汉霖自主研发的地舒单抗生物类似药，拟用于治疗骨折高风险的绝经后妇女的骨质疏松症及/或与参照药药品标签相符的其他适应症。地舒单抗是安进原研的一种人源化单克隆抗体药物，通过抑制破骨细胞活性，主要用于治疗骨质疏松症和骨巨细胞瘤。公开资料显示，全球已有5家药企的地舒单抗生物类似药获批上市，除复星医药外，其余四家分别是山德士、赛特瑞恩制药、三星生物和费森尤斯卡比制药。IQVIA MIDAS最新数据显示，2024年，地舒单抗注射液产品全球销售额约为74.62亿美元。 3 科奕药业纳米双抗ADC近12亿美元出海 9月2日，科奕药业宣布与国际生物医药公司RADIANCE Biopharma（以下简称“Radiance”）达成独家授权合作。科弈药业将旗下全球首个纳米双抗ADC药物KY-0301的海外开发、注册及商业化权益授予Radiance。根据协议条款，科弈药业将获得1500万美元首付款，以及最高1.5亿美元研发注册里程碑款和最高10亿美元商业化里程碑款，还将依据授权区域年度净销售额获得递进式销售分成。 KY-0301是科弈药业自主开发的全球首个纳米双抗ADC，于2024年获得美国IND许可，目前正在进行中国临床I期剂量递增试验。相比传统双抗ADC，KY-0301展现出更有效的肿瘤组织穿透性、更高的抗肿瘤活性和更优的安全性。基于MET和EGFR的肿瘤广谱高表达和差异化创新设计，KY-0301有望在非小细胞肺癌、结直肠癌、头颈鳞癌等治疗领域带来新突破。编辑：范晓艳版式编辑：余远泽审校：马飞、张松医保定点村卫生室监管升级！数千亿第三终端市场生变？中报来了，一起感受上市连锁的热浪和凉意业绩暴增919%！港股创新药高开反弹：百济、荣昌、君实、绿叶领涨 www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

抗体药物偶联物上市批准临床1期生物类似药财报

2025-09-02

·药圈头条

最新！复星医药「地舒单抗」获FDA批准上市

金秋10月，相聚海南【中国药企出海论坛】免费参会今日（9月2日），复星医药发布公告，其控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司自主研发的 60 mg/mL、120 mg/1.7mL 两项规格的地舒单抗注射液（项目代号：HLX14）的生物制品许可申请（BLA）获美国 FDA批准。 HLX14 为复星医药自主研发的地舒单抗生物类似药，拟用于治疗骨折高风险的绝经后妇女的骨质疏松症及/或与参照药药品标签相符的其他适应症。除本次获批外，HLX14 于其他主要国家/地区的注册进展包括：（1）2024 年 5 月，HLX14 的上市许可申请（MAAs）获欧洲药品管理局（EMA）受理、并已于 2025 年 7 月获 EMA 人用医药产品委员会（CHMP）的积极审评意见；（2）2024 年 9 月， HLX14 的上市注册申请（NDSs）获加拿大卫生部（Health Canada）受理。截至2025年7月，复星医药现阶段针对 HLX14 的累计研发投入约为人民币 3.23 亿元（未经审计）。目前，全球已有 5 家药企的地舒单抗生物类似药获批上市，除复星医药外，其他分别是山德士、赛特瑞恩制药、三星生物和费森尤斯卡比制药。根据 IQVIA MIDAS™最新数据2024 年，地舒单抗注射液产品于全球范围的销售额约为 74.62 亿美元。欢迎加入群聊

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100 项与 Fresenius SE & Co. KGaA 相关的药物交易

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100 项与 Fresenius SE & Co. KGaA 相关的转化医学

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药物(靶点)	适应症	全球最高研发状态

阿达木单抗生物类似药(Merck Serono SA) ( TNF-α )	斑块状银屑病更多	批准上市
托珠单抗生物类似药(Fresenius Kabi ) ( IL-6RA )	类风湿关节炎更多	批准上市
多西他赛 ( Tubulin )	头颈部肿瘤更多	批准上市
地舒单抗生物类似药 (Fresenius Kabi) ( RANKL )	骨质疏松症更多	批准上市
乌司奴单抗生物类似药 (Formycon) ( IL-12p40 )	银屑病关节炎更多	批准上市