A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID)

The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).

开始日期2021-03-31

申办/合作机构

Kedrion SpA

EUCTR2020-003570-49-CZ / Not yet recruiting临床3期

Phase III, Open-label, Uncontrolled, Multicenter Study to Assess Efficacy, Pharmacokinetics and Safety of IMMUNORHO in the Prevention of RhD Isoimmunization in Rh(D) negative Women Pregnant with Rh(D) positive Foetuses

开始日期2021-03-10

申办/合作机构

Kedrion SpA

NCT04345679 / Unknown status早期临床1期

Anti COVID-19 Convalescent Plasma Therapy

Why is the research needed? The pandemic known as COVID-19 is now spreading across the world with currently (April 10, 2020) more than 1 115 530 active cases and 96 791 deaths. In most affected countries the current goal is to 'flatten the curve' of the epidemic since there is no health care system that is able to treat an extremely high volume of patients all at once. There is a need for immediately applicable treatments for the patients at highest risk, which gains time until targeted therapies become available. A key feature in the pathomechanism of the disease is that the virus elicits an immunological over-reaction in the human body termed 'cytokine storm'. In susceptible patients this hyper-inflammation itself is a significant burden and may even inhibit the body to generate antibodies against the virus in adequate quantities. Therefore, identifying the subset of patients with excess cytokine response and supplementing them with convalescent plasma from recovered donors may be a life-saving treatment option.
What is our study about? In light of recent promising data on plasma therapy in the treatment of COVID-19 and other viral epidemics, there is a need for better understanding the cytokine response to the virus in order to better characterize the target population for convalescent plasma therapy.
Our hypothesis is that convalescent plasma transfusion from healthy donors who recovered from SARS CoV-2 is able to reduce the cytokine storm in addition to replenish the patient's own antibodies in the acutely infected phase of the disease.
A plasmapheresis donation of 400ml will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma donation. The sample will be tested for anti-SARS CoV-2 neutralizing antibody titers and those that reach the level of 1:320 will be processed for transfusion at the Hungarian National Transfusion Service.
Recipients will be COVID-19 patients requiring hospitalization regardless of the severity of the disease or other co-morbidities. A blood-type matched transfusion of 200 ml convalescent plasma will be infused in a single sitting through an iv. infusion of 4 hours.
Recipients will be followed up at days 1, 3,7,12, 17, 28 for clinical symptoms, antibody levels and cytokine response.

开始日期2020-04-14

申办/合作机构

OrthoSera GmbH

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项与 Kedrion SpA 相关的文献（医药）

2024-04-01·Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis

Hereditary factor X deficiency in America survey: impact on quality of life and burden of disease in patients and caregivers

Article

作者: Stanford, Richard H. ; Garner, Denise A. ; Clark, Kim ; Wolford, Eric ; Huang, Shirley P. ; Branchford, Brian

The aim of this study was to:

describe the diagnosis path, disease burden, and HFXD impact on quality of life (QoL) in patients and caregivers.This was a prospective, cross-sectional, web-based survey of patients with HFXD and caregivers addressing the patient/caregiver experience, QoL, humanistic and unmet needs.Thirty patients and 38 caregivers completed the survey with mean ages 24.7 and 44.6 years, respectively. Mean age at diagnosis was 4.1 years. The diagnostic process was somewhat/very difficult for 23% of patients and 26% of caregivers. Approximately half (53%) received single factor replacement (SFR) as prophylaxis or on-demand. Most patients (71%) reported regular prophylaxis treatment. Over one-fourth (27%) reported treatment with fresh frozen plasma. Bleeding episodes were less common in patients using SFR versus non-SFR: three bleeds or fewer were reported by 92% SFR and 75% non-SFR patients. HFXD patients reported low well being in work/school/social activities with mean HFXD-adapted Hemophilia Well being Index. Patient symptoms negatively impacted caregiver burden with a mean HFXD-adapted Hemophilia Caregiver Index (±SD) of 15.9 (4.6), but also unexpectedly had a positive impact on self-worth and inner strength.To our knowledge, this is the first study to assess patient and caregiver burden of HFXD and impact on QoL. Improvements in symptom recognition, prompt diagnosis, and adherence to expert recommendations for treatment could improve QoL and decrease burden on HFXD patients and caregivers.

2023-11-01·Haemophilia : the official journal of the World Federation of Hemophilia

Plasminogen, human‐tvmh for the treatment of children and adults with plasminogen deficiency type 1

Article

作者: Shapiro, Amy D ; Thibaudeau, Karen ; Crea, Roberto ; Nakar, Charles ; Parker, Joseph M ; Sandset, Per Morten

Abstract:

Aim:

An open‐label phase 2/3 study of plasminogen, human‐tvmh administered intravenously in paediatric and adult subjects with type 1 plasminogen deficiency was conducted. Interim data was previously reported. The final data on 15 subjects who completed the study up to a maximum of 124 weeks are reported here.

Methods:

The primary objectives were to evaluate efficacy of plasminogen replacement therapy on clinically evident or visible lesions during 48 weeks of dosing and to achieve an increase in trough plasminogen activity levels by at least an absolute 10% above baseline during 12 weeks of treatment.

Results:

The primary efficacy endpoint was achieved, as 100% of subjects (n = 11) with visible and assessable non‐visible lesions at baseline demonstrated ≥ 50% improvement after 48 weeks of study drug treatment with plasminogen, human‐tvmh. All subjects achieved the targeted ≥ 10% increase in trough plasminogen activity above baseline through Week 12. Plasminogen, human‐tvmh at a dose of 6.6 mg/kg administered every 2–5 days for 48 weeks and every 1–7 days for up to 124 weeks was well tolerated.

Conclusion:

This study provides additional evidence regarding the long‐term safety and clinical utility of replacement therapy with human plasminogen for the treatment of children and adults with type 1 plasminogen deficiency. Plasminogen, human‐tvmh received marketing approval on June 4, 2021. This trial was registered at www.clinicaltrials.gov as #NCT02690714.

2021-07-03·Human vaccines & immunotherapeutics3区 · 医学

Safety and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure

3区 · 医学

Article

作者: Amega, Novinyo ; Nguyen, Huy-Binh ; Hobart-Porter, Nicholas ; Stein, Michal ; Toh, Naveh ; Linakis, James

Rabies is a deadly viral zoonosis with global disease burden. Following exposure to a rabid animal, post-exposure prophylaxis (PEP) is the standard of care for unvaccinated persons. Despite the large proportion of pediatric cases, limited safety and efficacy data exist for use in pediatric patients. We report the safety, efficacy, and immunogenicity of a phase 4, prospective, 2-center, open-label, single-arm clinical trial evaluating human rabies immunoglobulin (HRIG150; KEDRAB 150 IU/mL) as part of PEP in patients (aged <17) with suspected or confirmed rabies exposure, where PEP was indicated. Thirty participants received 20 IU/kg HRIG150 infiltrated into the detectable wound site(s), with any remainder injected intramuscularly, concomitantly with the first of a 4-dose series (days 0, 3, 7, and 14) of rabies vaccine. Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration. Participant safety was monitored for 84 days. No serious adverse events, rabies infections, or deaths were recorded. Twenty-one participants (70.0%) experienced a total of 57 treatment-emergent adverse events (TEAEs) within 14 days following administration. Twelve participants (40.0%) experienced a total of 13 adverse events deemed treatment related. All TEAEs were mild in severity. On day 14, 28 participants (93.3%) had RVNA levels of ≥0.5 IU/mL (mean±standard deviation: 18.89 ± 31.61). These results demonstrate that HRIG150 is well tolerated and effective in pediatric patients as a component of PEP. To the authors' knowledge, this study is the first to establish pediatric safety and efficacy of HRIG in the US.

项与 Kedrion SpA 相关的新闻（医药）

2024-10-02

·PRNewswire

Kedrion and Biotest complete long-term Exclusive Distribution Agreement for Yimmugo® in the US

Contractual terms finalized and definitive agreement between Kedrion and Biotest signed based on framework agreed in July Distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities of Yimmugo® over the seven-year term Preparations for launch of Yimmugo® in the United States in 2025 well underway FORT LEE, N.J., Oct. 2, 2024 /PRNewswire/ -- Following the agreement of binding terms signed in July 2024, Kedrion Biopharma Inc. and Biotest AG have now finalized the contractual terms of the long-term strategic agreement for the full commercialization and distribution of Biotest Immunoglobulin Yimmugo® in the United States. The exclusive distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities of Yimmugo® over the initial seven-year term. Continue Reading immunoglobulin G (IgG) antibody Immunoglobulin therapies, such as Yimmugo®, play a key role in managing Primary Immunodeficiencies (PID), which affect approximately 500,000 people in the US.¹ Production of the quantities needed to enter the United States began immediately after the Biologic License Application (BLA) was approved, and is ongoing. Preparations for the product's market launch in 2025 are well underway. Yimmugo® is produced using a state-of-the-art process at Biotest's new FDA-certified "Next Level" production facility in Dreieich, Germany. The modern production process aims to achieve high product quality and promotes a responsible use of resources. With the US market for Immunoglobulin expected to grow by approximately 9% each year over the next eight years, distributing Yimmugo® will enable Kedrion to stay ahead in meeting market demand and reaching more patients with Primary Immunodeficiency disorders. "At Kedrion, we are committed to understanding the needs of patients and customers, and we are thrilled to bring Yimmugo® to the US market. In this climate of growing demand and awareness for Primary Immunodeficiencies, we see an incredible opportunity to make a meaningful impact on the lives of those who need it most" said Bob Rossilli, Chief Commercial Officer at Kedrion. About Yimmugo® (immune globulin intravenous, human - dira), 10% liquid Yimmugo® is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg) for the treatment of primary humoral deficiency (PID) in patients 2 years of age or older. Yimmugo® is the first approved product from the new Biotest Next Level production facility. IMPORTANT SAFETY INFORMATION BOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE See full Prescribing Information for YIMMUGO. Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. (5.3) Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. (5.4) For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (2.1, 2.3, 5.3) About Kedrion Kedrion Biopharma is a biopharmaceutical company that collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing rare and debilitating conditions like Coagulation and Neurological Disorders, Primary Immunodeficiencies, and Rh sensitization, which can lead to Hemolytic Disease of the Fetus and Newborn. Kedrion is a global player in plasma derivatives and rare disease medicines employing 5,100 people worldwide. The company has a plasma collection footprint of 68 centers operated by KEDPLASMA in the United States, and of 8 centers operated by UNICAplasma and Plasmafera in the Czech Republic, and a portfolio of 37 products distributed in over 100 countries around the world. With these figures, Kedrion is the world's 5th top player in the field of plasma-derived products. We work on a global scale to expand patient access to plasma-derived therapies. kedrion.com This release includes "forward-looking statements," within the meaning of the securities laws and certain other jurisdictions, based on current expectations and projections about future events. All statements other than statements of historical facts included in this release, including, without limitation, statements regarding our future financial position, risks and uncertainties related to our business, strategy, capital expenditures and our plans and objectives for future operations, may be deemed to be forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties. Words such as "believe," "expect," "anticipate," "may," "assume," "plan," "intend," "will," "should," "estimate," "risk," "target," "objectives," "outlook," "probably," "project," "seek" and similar expressions or the negatives of these expressions are intended to identify forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Duccio Manetti, Chief Communication Officer: [email protected]; +39 0583 767534 ¹Primary Immune Deficiency Diseases (PIDDs) | NIAID: National Institute of Allergy and Infectious Diseases (nih.gov) SOURCE Kedrion Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出上市批准免疫疗法

2024-09-12

·PRNewswire

Kedrion Biopharma's Focus on Advancing Patient Care in Rare Disease to be Showcased at NBDF Conference 2024

ATLANTA, Sept. 11, 2024 /PRNewswire/ -- Kedrion Biopharma Inc. is excited to announce its sponsorship of the National Bleeding Disorders Foundation's (NBDF) 76th Annual Bleeding Disorders Conference (BDC) in Atlanta, Georgia. The event will take place from September 12-14, 2024, and will bring together individuals with bleeding disorders, their families, healthcare professionals, and researchers from across the country. Kedrion's sponsorship of the NBDF underscores the company's commitment to supporting the bleeding disorders community. Kedrion is a leading manufacturer of coagulation and rare disease therapies and is dedicated to providing patients with access to innovative treatments. The NBDF Conference is a unique opportunity for attendees to learn about the latest advancements in bleeding and clotting disorders research and treatment, connect with other individuals and families affected by these conditions, and gain valuable insights from experts in the field. The conference will feature a wide range of educational sessions, workshops, and networking opportunities, covering topics such as: Treatment options and advancements: Attendees will have the chance to learn about the latest developments in treatment options for various bleeding and clotting disorders, including new therapies and clinical trials. Living with a bleeding and or clotting disorder: The conference will address the challenges and opportunities associated with living with a diagnosis, including managing symptoms, navigating healthcare systems, and building support networks. Research and advocacy: Attendees will gain insights into ongoing research efforts and advocacy initiatives aimed at improving the lives of individuals with such disorders. Kedrion will be actively involved in the NBDF Conference, hosting several events and activities designed to engage with attendees and share information about its therapies. Highlights will be a Campfire presentation on the results of the Hereditary Factor X in Americas survey, the 2nd Annual Plasminogen Deficiency Roundtable and The Ultra Rare Networking Hour, a dedicated space for individuals with ultra-rare bleeding and or clotting disorders and their support network to connect and build relationships. This initiative will foster a sense of community and provide a platform for sharing experiences and resources. The NBDF Conference is also a valuable opportunity for Kedrion to connect with individuals living with Plasminogen Deficiency Type 1(PLGD-1), as well as patients with Hereditary Factor X Deficiency (HFXD), two rare and potentially life-threatening disorders. The company will be sharing information about the therapy developments in these areas and its ongoing research efforts. "At Kedrion, every employee is united by a powerful mission: to amplify the voices of patients with rare diseases and to continually improve their journey and care. Together, our global commitment ensures that every step forward is a step towards a brighter, more hopeful future" said Bob Rossilli, CCO, Global Business and US General Manager of Kedrion. Kedrion's participation in the NBDC reflects the company's commitment to improving the lives of individuals with rare diseases. By providing support, education, and access to innovative therapies, Kedrion is working to ensure that patients have the resources they need to live full and healthy lives. To learn more about the NBDF's 76th Annual Bleeding Disorders Conference, please visit National Bleeding Disorders Foundation, formerly NHF | NBDF. Contact: Jennifer Bayliss / [email protected] / 213-703-9604 SOURCE Kedrion Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-08-27

·E药经理人

如何平衡血液制品的需求和供应——专访国际血浆蛋白治疗协会总裁

血液制品行业很特殊。强监管下，扩大产量难上加难；监管不够严格，则会带来安全风险。如何在其中保持平衡，增大供应量的同时减少风险，建立多层次的安全保障，一直是行业孜孜不倦研究的命题。而推动各国监管机构之间标准对齐，实现全球在血浆行业的标准统一化，或是实现该目标的重要手段之一。撰文| 石若萧在庞大复杂的医药产业中，血液制品是一个十分特殊的子行业。首先，血液和血浆制品有着非常广阔的医疗潜力，例如血浆中含有各种蛋白，将其提取并开发的血浆衍生疗法可以治疗多种疾病或危重状况，如白蛋白产品可用于休克、创伤或者烧伤等急症的救治。而随着科技发展，其应用范围也越来越广，长久以来的成功应用已经证实，血浆衍生疗法除了能用于治疗出血性疾病，还可用于原发性免疫缺陷疾病(PID)、慢性炎症性脱髓鞘性多发性神经病（CIDP）以及其他通常是遗传性或者慢性疾病的治疗，并且用于继发性免疫缺陷的需求也在增长。一组数据显示，全球患者对免疫球蛋白需求增长率更是达到了每年8%。在中国，根据中国原发性免疫缺陷疾病关爱中心PID Care China的数据，大约有200万免疫缺陷疾病的患者，对血浆衍生疗法需求迫切。不过日益扩大的需求的另一面，进一步凸显了血浆采集不足带来的挑战。绝大多数血浆制品无法由转基因动物细胞制成或在实验室制作，来源仅有依赖人类捐献一途。其流程也颇为复杂耗时：捐浆者要到专业的血浆捐献中心操作，先接受病毒筛查以及暴露风险特征筛查，若携带任何病毒标志物则不能捐献，之后再由工作人员将捐浆者全血抽出，通过血浆分离机分离出血浆并将其他部分输回捐献者体内，同时再通过静脉注射或其他形式补充流失的血容量。 “从采集到最后成为治疗方案，再到真正成药，这个过程要花比较久的时间，一般会是9到12个月。”国际血浆蛋白治疗协会(PPTA)总裁兼首席执行官安妮塔·布里克曼（Anita Brikman）对E药经理人介绍。血浆本身的这种固有特点，意味着这个行业始终存在需求与供应难以匹配的根本矛盾。而这个行业的运营又受到严格的法规约束，只有当这些约束措施能够兼顾风险和安全，避免对血浆采集施加不必要的限制，运营效率才能提升。强有力的监管是必要的，虽然它可能会增加产量扩大的难度，但可以减轻潜在的安全隐患；弱监管，会带来大量安全风险，比如各类血源性传染病的传播。因此如何在其中保持平衡，增大供应量的同时，改进制造等过程中的步骤来消除风险，建立多层次的安全保障，一直是行业孜孜不倦研究的命题。为实现这一目标，推动各国监管机构之间标准对齐，实现全球在血浆行业的标准统一化，是一个重要手段。近日，国际血浆蛋白治疗协会(PPTA)总裁兼首席执行官安妮塔·布里克曼（Anita Brikman）来到中国进行访问，希望推动全球在血浆行业的标准统一化。作为一家代表血浆衍生疗法制造企业和血浆采集中心的全球性行业协会，PPTA致力于与各国政府和卫生系统建立合作伙伴关系，推动血浆衍生疗法的可及性，支持患者和捐浆者，为血浆衍生疗法相关跨国企业及血浆采集机构提供共同的方法。安妮塔·布里克曼（Anita Brikman）国际血浆蛋白治疗协会(PPTA)总裁兼首席执行官据安妮塔·布里克曼介绍，PPTA总部在美国华盛顿，在比利时的布鲁塞尔亦设置有办公室，成员公司在美国、欧洲部分国家、埃及和加拿大等国家和地区运营有超过1000个血浆捐献中心。成员公司在满足各国监管机构相关法规要求的同时，还遵守PPTA的两个自发性行业标准计划，包括用于血浆采集的国际优质血浆项目（International Quality Plasma Program, IQPP）和用于制造的卓越、保证和领导质量标准（Quality Standards of Excellence, Assurance and Leadership, QSEAL）。安妮塔·布里克曼还表示，多国案例已证实，国内监管机构间标准对齐以及与国际标准对齐，对行业发展很有帮助。本次中国行程，希望通过具体的监管协调实施案例和专业经验的分享，助力中国及全球更多的国家和地区获益。 Q=E药经理人 A=安妮塔·布里克曼国际血浆蛋白治疗协会总裁兼首席执行官 Q：请你分享一下此次到中国来的初衷，以及想要实现哪些目标？ A：2017年，PPTA就和中国药典委合作，致力于帮助推动中国产业的标准化，包括进一步实现血浆采集和浆站发展等方面的标准化。这是我加入PPTA后第二次来到中国。去年在中国北京参加了血液安全大会。今年来到中国，希望可以深入拜访一些临床一线的医生，也会拜访政府部门一些领导及一些患者组织，探讨一些合作机会。 PPTA是一个以科学驱动的机构，也是一个标准制定组织，也有自己的标准认证项目。如果某个公司想要做血浆采集，这些自发性标准可以帮助他们实施符合最高质量和安全水平的流程和体系。会员公司可以用该标准进入他们想要拓展的市场中，进行合规与业务拓展。我们会员药企中有两家，武田和基立福，本身就是在中国市场上白蛋白领域非常重要的两个提供商。此外，另一家会员公司Kedrion最近也在中国获得了白蛋白产品的批准。总结下来，PPTA主要的使命在三大方面：第一，希望能够通过捐赠中心或者是捐赠这块的工作来实现更强的血浆制品的可获得性；第二，我们希望能够提高患者对血浆制品的可及性，尤其是依赖于这些疗法的罕见病患者；第三，我们希望提高社会对于血浆捐献和血浆衍生疗法的认知。三点分别对应了血浆衍生疗法可获得性、可及性和认知提升三个方面。 Q：现在PPTA建立起来的这些标准具体都有哪些？ A：国际优质血浆项目（International Quality Plasma Program, IQPP）包括11项标准，专注于最终产品的安全性和捐献者的安全性。举例来说，我们有一个基于社区的捐献者标准，要求捐献者应居住在采集中心附近；还有一个交叉捐献管理标准，这是一个检查系统，以确保捐献者不会过于频繁地捐献；捐献者还会接受健康生活方式的教育，以帮助确保健康的捐献，并在血浆捐献后给予液体补充，以弥补血浆损失的体液。此外，在美国，我们还有一个美国捐献者延期登记系统（National Donor Deferral Registry, NDDR）。这是一个记录系统，如果检测中发现某人有病毒标记，该人将不能捐献。这些是美国和欧洲非常广泛接受的一些标准。我们正在努力推广这些标准，以帮助其他国家和地区的企业都能积极参与进来，确保药品的最佳安全性和质量水平。目前希望在中国或者是更多的国家来推广这些标准体系，能够推动各国的标准一致化。 Q：血液制品在各国都是一个高监管的领域，如何在建立高标准基础的同时扩大血液制品的应用范围？ A：整个制浆行业主要包括两个方面：一方面是采集血浆，一方面是在这之后的产品制造过程，如白蛋白或者免疫球蛋白等。因此想要提高效率，就要在采集这一侧和生产这一侧，都确保各个公司或者各个中心都有一套整体化的或者是一致性的操作。此外，血液和血浆制品领域的独特之处在于，不仅原材料的采集受到严格监管，药品生产过程也同样受到严格监管。并且不仅有本地监管机构的检查，还有来自最终产品可能使用的其他国家的监管机构对血浆采集中心和生产设施的检查（例如，欧洲监管机构检查美国的设施，或中国监管机构验证欧洲的设备）。PPTA致力于确保各个检查机构的检查过程协调一致。 Q：你认为中国的血液制品企业在全球范围的影响力和竞争力怎么样？ A：中国的血浆制品公司目前正在进入一个高速发展期，如果中国企业和其他国家的企业能够更深入的融合，则可以更好地服务患者。我们了解到在中国市场中目前血浆制品企业有30家左右，采浆中心有300个左右。其中有些企业已经在向国外出口产品。对中国这样一个体量的市场来说，考虑到需要治疗的患者数量，血浆采集和制造方面具有很大的发展空间，同时如果与全球市场进行更深的融合，对于供应不足也可以产生影响；另一点，中国在血浆制品的利用率目前也相对较低，比如IVIG的利用率，与其他国家相比还有增长空间。如果中国企业能够更多地参与到国际市场上，能够更好地满足国际上这样一个需求缺口。 Q：怎么提升血浆利用率？这一点你对中国的血液制品企业有什么建议？ A：建议主要有三个方面。第一，目前血浆产品没有进入到医保目录范围，所以患者在使用时会有经济上的疑虑，如果能纳入医保的名单，这将是推动利用率增强的很好的措施；第二，有什么样的临床指征才可以用这些血浆产品？在这个指征和诊断上如果能有改善，利用率也会提高。最后呢，加强对国际生产疗法的了解和获取也可以提升利用率。以上问题都并非中国独有，各个国家和地区的监管机构都普遍存在。因此问题在于提高政府的认识，改进报销模式，扩大适应证。此外，如果中国的血浆采集中心数量一直在增长，并且更深入地嵌入全球市场，也可以促进利用率。 Q：目前多项并购表明，中国的血液制品公司的集中度在提升。从全球来看，血液制品产业是朝着集中化发展，还是朝分散化发展的？ A：本身这个行业就是高监管、高科技含量，基础设施和前期投入都特别大，这也是行业集中度较高的原因之一。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

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