A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).

开始日期2019-01-18

申办/合作机构

Instituto Grifols SA

EUCTR2016-004489-24-BG

/ Unknown status临床3期

A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.

开始日期2018-09-13

申办/合作机构

Instituto Grifols SA

EUCTR2016-004489-24-HU

/ Unknown status临床3期

开始日期2018-06-21

申办/合作机构

Instituto Grifols SA

100 项与纤维蛋白粘合剂（Grifols）相关的临床结果

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100 项与纤维蛋白粘合剂（Grifols）相关的转化医学

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100 项与纤维蛋白粘合剂（Grifols）相关的专利（医药）

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项与纤维蛋白粘合剂（Grifols）相关的文献（医药）

2024-11-01·Journal of Pediatric Surgery

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery

Article

作者: Jenovari, Zoltan ; Mondou, Elsa ; James, Michael K. ; Balanescu, Laura ; Bozzo, Jordi ; Kalinova, Krasimira ; Camprubí, Sandra ; Sharif, Khalid ; Camprubí, Sandra ; Ninov, Borislav ; Mikickovic, Maja ; Vajda, Péter ; Querolt, Montse ; Sretenović, Aleksandar ; Gajdobranski, Djordje ; Simeonov, Simeon ; Mondou, Elsa ; Slavkovic, Andjelka ; Hanna, Kim ; Hanna, Kim ; Irtan, Sabine ; Querolt, Montse ; Kamenov, Krasimir ; Wiener, Isodoro

BACKGROUNDIn this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.METHODSThis phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T₄ - primary endpoint), seven (T₇) and 10 (T₁₀) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible.RESULTSAt T₄, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T₄ were undergoing soft tissue surgery. All patients achieved hemostasis by T₇. At T₁₀, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications.CONCLUSIONSFS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel.LEVEL OF EVIDENCEI.

2024-06-01·CARTILAGE

Mechanical Evaluation of Commercially Available Fibrin Sealants for Cartilage Repair

Article

作者: Amirhekmat, Arya ; Wang, Dean ; Hu, Jerry C. ; Brown, Wendy E. ; Athanasiou, Kyriacos A. ; Salinas, Evelia Y.

Objective Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model. Design Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated. Results There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of <8 and <30 kPa, respectively. There were no differences in COF between the sealants when tested alone or with minced cartilage. A double application of fibrin sealant did not alter the mechanical properties compared with a single application of fibrin sealant. Conclusions Fibrin sealant adhesive properties are not affected by the sealant type studied or the number of applications in a bovine cartilage-bone model. Fibrin sealant tribological properties are not affected by sealant type or the addition of minced cartilage. The adhesive properties of Tisseel and Vistaseal were less than those desired for the in vivo fixation of cartilage repair implants. These findings motivate the development of an improved cartilage-specific adhesive for cartilage repair applications.

2023-04-01·Journal of Biomedical Materials Research Part A

A comparative high‐resolution physicochemical analysis of commercially available fibrin sealants: Impact of sealant osmolality on biological performance

Article

作者: Manhartseder, Stefan ; Hartmann, Jaana ; Singh, Rahul ; Heher, Philipp ; Gulle, Heinz ; Reichsöllner, Raffael ; Slezak, Paul

AbstractFibrin sealants are well‐established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue‐adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in‐depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ (“FS”) and VISTASEAL™/VERASEAL™ (“FS+Osm”). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis—a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ.

项与纤维蛋白粘合剂（Grifols）相关的新闻（医药）

2024-10-29

·GlobeNewswire-Health Care

Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin Sealant Solution

Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasisGrifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding has received approval from the United States Food and Drug Administration (FDA) for pediatric patients. The U.S. indication for children and adolescents extends the availability of FS, which is already approved for this patient segment in Europe, in addition to adults. During surgery Grifols FS promotes hemostasis and tissue sealing, resulting in reduced blood loss and potentially fewer complications. Grifols FS biosurgery treatment is commercialized as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe and elsewhere. Both brands are marketed and distributed by Johnson & Johnson MedTech, as part of a strategic collaboration between the two companies announced in 2019. Grifols FS combines two plasma proteins, fibrinogen and thrombin, and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. The FS solution is now available in 18 countries. In early 2023, Grifols announced that it had met all primary and secondary endpoints of its phase 3b study evaluating the administration of Grifols FS to pediatric patients, defined as those not having reached 18 years of age. Researchers conducted a global prospective, randomized, active-controlled, single-blind, parallel group clinical trial designed to evaluate the safety and efficacy of the FS as an adjunct to hemostasis during surgery in pediatric patients (compared with an active control). The study included a total of 178 patients enrolled and treated across 18 recruitment centers. A greater than 95% efficacy rate was achieved in both treatment arms, with hemostasis within four minutes of application. In addition, Grifols FS demonstrated a good safety and tolerability profile, as the distribution of adverse events was comparable between arms. “Developing innovative biosurgery solutions reflects Grifols’ ability to provide patients with more medicines across many therapeutic areas to enhance their well-being,” said Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer. It’s estimated that between roughly one-third and two-thirds of open surgeries experience disruptive bleeding,1 while challenging and uncontrollable bleeding during surgery is associated with high mortality rates.1,2 About VISTASEAL VISTASEAL is a single-use product that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis. VISTASEAL can be utilized in high-risk patients when there are concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue. VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION INDICATIONVISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL™ is effective in heparinized patients. CONTRAINDICATIONSDo not inject directly into the circulatory system. Do not use for the treatment of severe or brisk arterial bleeding.Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.Do not use VISTASEAL™ for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. WARNINGS AND PRECAUTIONS Thromboembolic events may occur if VISTASEAL™ is administered intravascularly. Hypersensitivity reactions can occur. May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ADVERSE REACTIONSThe most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.MEDIA CONTACTS: Grifols Press Office media@grifols.comTel. +34 93 571 00 02 SpainDuomo ComunicaciónTel.: +34 91 311 92 89 – +34 91 311 92 90Raquel Lumbreras (Tel. +34 659 572 185)Raquel_lumbreras@duomocomunicacion.comBorja Gómez (Tel. + 34 659 572 185)Borja_gomez@duomocomunicacion.com InvestorsInvestors Relations & Sustainabilityinversores@grifols.com - investors@grifols.comTel. +34 93 571 02 21 About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information about Grifols, please visit grifols.com LEGAL DISCLAIMERThe facts and figures contained in this report that do not refer to historical data are “future projections and assumptions.” Words and expressions such as “believe,” “hope,” “anticipate,” “predict,” “expect,” “intend,” “should,” “will seek to achieve,” “it is estimated,” “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group. 1 Corral M, Ferko N, Hollmann S, Broder MS, Chang E. Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database. Clinicoecon Outcomes Res. 2015;7:409-421. doi:10.2147/CEOR.S863692 Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of bleeding in surgery. Transplant Proc. 2006;38(3):812-814. doi:10.1016/j.transproceed.2006.01.047

临床3期临床结果上市批准

2024-02-28

·Pharmaceutical Technology

Grifols prepares for late-stage plans with plasma-derived medicines in 2024

In an exclusive interview with Pharmaceutical Technology, Grifols declared plans for multiple Phase III readouts in 2024. Credit: Bloomberg via Getty Images Grifols plans to release Phase III results of its long-term albumin treatment designed to increase survival time in patients with decompensated cirrhosis and ascites in 2024, says chief scientific innovations officer Jorg Schüttrumpf. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report. Related Company Profiles Grifols SA Ethicon US LLC Johnson & Johnson Biotest AG View all In an exclusive interview with Pharmaceutical Technology, Schüttrumpf outlined the plasma derived-medicines company’s 2024 goals for its late-stage candidates as several trials come to a head. The aforementioned Preciosa trial (NCT03451292) studying human albumin is focused on patients awaiting a suitable transplant. Grifols also plans to release data from its Phase III ESsCAPE study (NCT05722938), investigating trimodulin, triple action immunoglobulin with IgM, IgA and IgG, at some point this year. In February, the company reported positive efficacy results from a trial investigating Grifols’ fibrinogen concentrate (FC), BT524, for the treatment of acquired fibrinogen deficiency (AFD). The company now plans to complete European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulatory submissions, in pursuit of approval. “We are working with different partners. In the immunology, and pulmonary disease space, to support their growth,” says Schüttrumpf. Additionally, the Spain-headquartered company is exploring partnerships similar to the one it has with Ethicon, says Schüttrumpf. Grifols began its collaboration with Ethicon, a subsidiary of Johnson & Johnson , in 2017, wherein Grifols agreed to exclusively manufacture and supply plasma-derived products for use in the biosurgery field for 10 years. See Also: Pelage secures funds to develop regenerative medicine for hair loss Praxis Precision Medicines sees highest patent filings and grants during November in Q4 2023 In 2021, Grifols announced the acquisition of Tiancheng (Germany) Pharmaceutical Holding s, which owned 89.88% of another plasma products specialist Biotest . Grifols is developing trimodulin and B524 with Biotest. Before the acquisition, Grifols had already explored fibrinogen concentrate for the development of Vistaseal (fibrinogen (human) + thrombin (human), commercialised as Veraseal in Europe. Schüttrumpf highlights Grifol’s ability to complete in-house manufacturing for plasma-derived therapeutics like BT524. He said that this gave the company a major advantage in its operations, also allowing it to offer its manufacturing services to other pharmaceutical companies. Grifols has plans to release its 2023 annual financial report on 29 February. 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临床3期并购临床结果

2023-09-12

·药智网

两款超十亿创新药品种将诞生，泽璟制药离Biopharma有多远？

据2023半年报显示，泽璟制药实现营收2.2亿元，同比增长108.66%；归母净利润亏损1.14亿元，同比大幅收窄1.33亿元。值得注意的是，泽璟制药有两款潜力产品杰克替尼、重组人凝血酶，均有望在2023年获批上市。由于竞争格局良好，未来进入医保后有望迅速放量，成为超10亿元的大品种，届时泽璟制药将拥有三大创新药。随着研发管线的逐渐兑现，泽璟制药离Biopharma还有多远？01首款创新药，多纳非尼进入放量爬坡期2021年以前，泽璟制药还没有任何创新药上市，由于巨额的研发投入，科创板上市后的两年内分别亏损3.19亿元及4.51亿元。2021年6月，泽璟制药迎来了首款创新药多纳非尼，正式开启了商业化之路。刚上市的多纳非尼可谓风光无限。作为我国首个国产肝癌一线靶向药，同时也是首个国产氘代药物，多纳非尼是目前全球唯一的在单药与索拉非尼进行头对头、随机、平行对照、一线治疗不可手术切除HCC患者的大型Ⅱ/Ⅲ期注册试验中，取得了总生存期（OS）等临床数据优效的靶向药物。临床结果显示，多纳非尼与索拉非尼相比能够明显延长晚期肝癌的中位生存时间，降低死亡风险，在安全性和耐受性方面都优于索拉非尼。凭借优异的临床数据，多纳非尼片被纳入《中国肿瘤整合诊治指南（CACA指南）》，同时被纳入卫健委《原发性肝癌诊疗指南（2022年版）》等13大指南和共识，并且是唯一被列入2022年版《中国临床肿瘤学会（CSCO）原发性肝癌诊疗指南》的国产原研靶向药。多纳非尼与索拉非尼化学结构图片来源：《临床肿瘤学杂志》上市之后的多纳非尼一路高歌猛进，上市仅半年，销售额就达到了1.63亿元。然而，多纳非尼面临的竞争压力与日俱增。在国内，多纳非尼的竞品包括索拉非尼和仑伐替尼。两者分别于2021年第4批及2022年第7批纳入国家集中采购目录，集采降价最高降幅分别达到75%和97%。面对竞品的大幅降价，多纳非尼的市场前景一度备受争议。然而，现实情况是，相比已进入集采的索拉非尼和仑伐替尼，不太可能再投入资源进行市场推广，多纳非尼已经进入医保，且得到国家和行业各级治疗指南的优先推荐，更有机会通过营销手段扩大市场份额。因此，在竞品集采导致肝癌一线靶向药物市场存量降低的情况下，多纳非尼凭借优效临床的优势，有望填补竞品纳入集采后空缺的市场空间。此外，多纳非尼于2022年8月获批用于治疗进展性局部晚期或转移性放射性碘难治性分化型甲状腺癌。这是多纳非尼第二个获批上市的适应症，新适应症获批进一步带动了市场放量。2023年上半年，泽璟制药实现营收2.20亿元，同比增长108.66%。同时，多纳非尼已经进入医院833家、双通道药房744家，在全国的覆盖范围进一步扩大，进入放量爬升期。02两大王牌即将获批，盈利之日已近？据数据显示，今年上半年，中国共196家生物医药企业在一级市场获得融资，总融资额达310亿元。相比去年同期，融资企业数量下降21.6%，融资总额下降28.6%。但泽璟制药却能“逆流而上”，屡获巨额融资。2020年，作为科创板首家未盈利公司，泽璟制药从A股市场募集资金20.26亿元后，又在今年成功完成12亿元的定增。为何泽璟制药能够在资本寒冬获得资本青睐？与自身强大的研发实力及王牌产品有关。除了上述拳头产品多纳非尼，泽璟制药还有两大王牌产品已处于新药上市评审阶段，分别是杰克替尼和重组人凝血酶。◆杰克替尼杰克替尼是一种广谱JAK激酶小分子抑制剂，对Janus激酶包括JAK1、JAK2、JAK3和TYK2具有显著的抑制作用。其在包括骨髓纤维化、重症斑秃等多个适应症表现出了广阔的前景。泽璟制药在杰克替尼上倾注了大量的资源，总投资规模达到11.6亿元（多纳非尼2.45亿元），开发的适应症包括：骨髓纤维化、重症斑秃、中重度特应性皮炎、强直性脊柱炎、特发性肺纤维化、中重度斑块状银屑病等，并且同时开发了片剂和乳膏剂两种剂型。其中，治疗中高危骨髓纤维化的新药上市申请已于2022年10月获国家药监局受理，成为第一个提交新药上市申请的国产JAK抑制剂类创新药物。骨髓纤维化（myelofibrosis，MF）是一种弥漫性骨髓纤维组织增生性疾病。全球范围内仅有芦可替尼、菲达替尼、帕克替尼三款产品获批，在国内则更是仅有芦可替尼一款产品获批。根据2023年ASCO公布的数据，在有效性方面，杰克替尼组SVR35达到72.3%，是芦可替尼在中国骨髓纤维化患者中的历史数据27%的近3倍。因此，杰克替尼有望成为治疗中高危骨髓纤维化“Best-in-Class”的产品，填补芦可替尼不耐受的中高危骨髓纤维化治疗的空白。◆重组人凝血酶重组人凝血酶是通过重组蛋白技术制成的具有高度特异性的蛋白药物，主要用于各种外科手术和创伤的止血上。是中国首个完成III期临床研究并提交上市许可申请的重组人凝血酶产品。随着中国外科手术台数的增长，外科手术局部止血药物市场呈现出较为稳定的增长，由2016年的63.1亿元增长为2020年的70.7亿元，并预计2025年及2030年分别达到123.5亿元及161.6亿元。中国外科手术局部止血药物市场规模图片来源：泽璟制药定增说明书目前，中国的外科手术局部生物止血药物主要为人血来源/动物血来源提取的凝血酶、蛇毒血凝酶以及纤维蛋白粘合剂。重组人凝血酶与之相比，特异性更高、止血效果突出，安全性更佳，同时成熟的重组蛋白工艺相较直接从血浆中进行提取成本也更低。泽璟制药两款潜力产品均有望在2023年获批上市，届时泽璟制药将拥有三大创新药，或将快速实现盈利，一举跨入Biopharma行列。03早期管线丰富，抗体平台优势凸显作为一家创新驱动型制药公司，泽璟制药通过其小分子药物研发及产业化平台、复杂重组蛋白新药包括双特异抗体和三特异抗体的研发及产业化平台，研发了一系列覆盖多个领域、具有差异化竞争优势的产品。截至2023年6月31日，泽璟制药拥有16个主要在研药品，其中3个在研药品处于NDA、III期或注册性临床试验阶段，9个在研药品处于I或II期临床试验阶段，3个在研药品处于临床前研发阶段。泽璟制药研发管线来源：泽璟制药官网同时，泽璟制药在江苏昆山、上海张江和美国加州拥有3个新药研发中心，分别从事生物新药、化学新药和创新抗体的研发。其中，子公司GENSUN自2018年被泽璟制药收购以来，一直作为其在美国的研发中心，从事肿瘤免疫领域的抗体药物的创新研发。GENSUN拥有三个候选药物研发平台TriGen、CheckGen和TGen，产品线包括ZG005、ZGGS18、ZG006、GS11、ZGGS15和ZGGS001等在内10余个候选抗体新药，分别处于临床前研究、IND和临床试验阶段。这其中不乏在全球范围内均具有领先性和竞争力的产品：ZG006是全球第一个针对DLL3表达肿瘤的三特异性抗体（CD3/DLL3/DLL3），具有成为FIC分子的潜力；ZGGS15是全球首个获批并即将进入临床试验的抗LAG-3/TIGIT双特异性抗体，有望用于治疗多种晚期实体瘤；ZGGS18是一种重组人源化抗VEGF/TGF-β的双功能抗体融合蛋白，目前暂无相同作用机制的药品在国内外获批上市或进入临床研究。随着在研管线的增加及药物临床试验研发规模的扩大，泽璟制药的研发投入也居高不下。2020年-2023年上半年，研发费用分别为3.14亿元、5.09亿元、4.98亿元及2.2亿元，三年累计超15亿元。04结语持续的研发投入，使泽璟制药在拥有多纳非尼、杰克替尼和重组人凝血酶三大具有差异化竞争优势产品的同时，后续研发管线不断扩展优化，形成波浪式发展态势，为其未来商业化发展提供持续动力。参考资料：1.泽璟制药半年报，官网2.《初具biopharma规模，泽璟制药：2023年多个品种能否持续兑现？》，天风证券，2023-07-10声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八角转载开白 | 马老师 18996384680（同微信）商务合作 | 张武龙 13368443108（同微信）阅读原文，是昨天最受欢迎的文章哦

财报CSCO会议上市批准

100 项与纤维蛋白粘合剂（Grifols）相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
凝血障碍	欧盟	Instituto Grifols SA	2017-11-10
凝血障碍	列支敦士登	Instituto Grifols SA	2017-11-10
凝血障碍	冰岛	Instituto Grifols SA	2017-11-10
凝血障碍	挪威	Instituto Grifols SA	2017-11-10
出血	美国	Instituto Grifols SA	2017-11-01

未上市

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
出血	药物发现	西班牙	Instituto Grifols SA	2008-02-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03461406 (CTgov)	临床3期	出血	186	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	選顧鑰鹽壓簾繭範艱顧(顧製醖願鏇積夢觸蓋範) = 鏇鏇餘襯簾範願齋夢遞壓顧構觸鹹醖膚蓋鏇簾 (鬱窪獵鬱憲網餘衊夢淵, 蓋蓋襯衊鏇窪艱願鏇顧 ~ 醖齋鬱艱築鏇鑰觸願齋) 更多	-	2023-04-07
				EVICEL (EVICEL)	選顧鑰鹽壓簾繭範艱顧(顧製醖願鏇積夢觸蓋範) = 製簾獵願獵鹽糧夢襯齋壓顧構觸鹹醖膚蓋鏇簾 (鬱窪獵鬱憲網餘衊夢淵, 淵糧衊醖廠構鬱淵衊衊 ~ 顧鹹醖觸廠夢觸範獵艱) 更多
NCT01662856 (CTgov)	临床3期	出血	225	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	膚鬱窪鹹糧遞膚構鏇憲(鏇糧築齋膚願繭窪構製) = 鏇壓選糧廠獵窪齋鹹願積壓積鑰繭願齋選蓋憲 (願淵積築觸鹽簾範鏇簾, 蓋網醖製獵觸膚範糧醖 ~ 鹽廠衊製選糧糧夢醖醖) 更多	-	2017-04-06
				Manual Compression (Manual Compression)	膚鬱窪鹹糧遞膚構鏇憲(鏇糧築齋膚願繭窪構製) = 衊願齋糧網鏇鏇顧鹹簾積壓積鑰繭願齋選蓋憲 (願淵積築觸鹽簾範鏇簾, 願壓網製積觸鏇鏇窪積 ~ 鑰窪蓋窪鏇簾觸艱鬱襯) 更多
NCT01731938 (CTgov)	临床3期	出血	327	Fibrin Sealant (FS) Grifols (Fibrin Sealant (FS) Grifols)	範簾鑰憲醖憲構範膚願(製鬱壓憲壓遞廠鏇鏇簾) = 觸淵壓網齋蓋簾顧製簾齋獵範築築簾獵醖願範 (醖艱遞鑰製築艱淵餘醖, 鏇壓範餘艱簾糧繭築觸 ~ 衊積鑰夢觸衊鹹衊廠夢) 更多	-	2017-02-23
				Surgicel® (Surgicel®)	範簾鑰憲醖憲構範膚願(製鬱壓憲壓遞廠鏇鏇簾) = 鏇繭鬱衊範繭淵淵遞簾齋獵範築築簾獵醖願範 (醖艱遞鑰製築艱淵餘醖, 鬱醖壓窪醖願壓積膚糧 ~ 積網選鑰築鑰醖願齋夢) 更多
NCT01754480 (CTgov)	临床3期	出血	325	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	鹽鑰壓壓積鬱淵簾蓋鏇(鑰積糧範廠選鏇餘蓋獵) = 襯襯簾鬱構齋鏇選選觸壓鹹積艱網鏇觸獵夢淵 (鬱繭鏇蓋簾壓顧襯襯選, 範網顧夢構膚廠餘簾淵 ~ 鑰鹽蓋蓋顧襯襯繭範廠) 更多	-	2017-02-08
				Surgicel® (Surgicel®)	鹽鑰壓壓積鬱淵簾蓋鏇(鑰積糧範廠選鏇餘蓋獵) = 壓簾齋襯襯鬱夢憲築廠壓鹹積艱網鏇觸獵夢淵 (鬱繭鏇蓋簾壓顧襯襯選, 壓顧蓋繭製繭範鑰鹽鹽 ~ 願廠簾網顧鏇憲糧網淵) 更多
NCT00684047 (CTgov)	临床2/3期	出血	239	FS Grifols (FS Grifols Primary Part (II))	廠壓鬱製襯膚齋膚製積(廠簾糧鑰遞衊選鹽糧醖) = 獵網膚鹽簾選製構糧膚選鏇壓窪願憲鹽襯觸網 (築衊醖網簾艱獵蓋遞膚, 蓋鏇醖觸艱憲窪壓膚廠 ~ 糧鬱鑰築簾選網鏇鏇製) 更多	-	2016-01-25
				Manual Compression (Manual Compression Primary Part (II))	廠壓鬱製襯膚齋膚製積(廠簾糧鑰遞衊選鹽糧醖) = 範觸繭襯築遞鬱衊襯鏇選鏇壓窪願憲鹽襯觸網 (築衊醖網簾艱獵蓋遞膚, 壓繭鹽鹽觸衊顧製鬱鑰 ~ 鏇鬱鹽遞網襯鬱鑰遞餘) 更多