Immune Globulin (Human)(Grifols)

皮下注射人免疫球蛋白（皮丙）：血制品市场的新蓝海与未来之星皮丙全称为皮下注射人免疫球蛋白("SCIG")，是由健康献血者的混合血浆制备而成的免疫球蛋白类血液制品药物，其主要成分是免疫球蛋白G(IgG)，由于注射途径不同，除SCIg以外，免疫球蛋白类药物还包括肌内注射免疫球蛋白(IMIg)以及静脉注射免疫球蛋白(IVIg)。由于IMIg会引起注射部位疼痛明显且不良反应大，IVIg和SCIg成为免疫球蛋白替代治疗的主要药物。SCIg的主要成分为IgG，IgG可分为抗原结合片段(Fab)和可结晶片段(Fc)，可作用于树突状细胞、单核/巨噬细胞、自然杀伤(NK)细胞、中性粒细胞等免疫细胞，发挥Fab和Fc的抗炎及免疫调节作用。其中，Fc作用机制包括激活Fcγ受体(FcγRs)、促进T细胞活化和增殖、抑制FcRⅡb上调、促进调节性T细胞(Treg)增殖等；Fab作用机制包括中和作用和抑制Th17的分化等。此外，IgG的糖基化和二聚体化也与抗炎作用相关，特别是IgG的Fc唾液酸化。例如在小鼠模型中，唾液酸化的IgG的Fc更能诱导抑制性FcγRⅡb的表达，从而发挥免疫调节的作用；二聚体可优先与FcγRs结合，从而增强FcγRs对免疫性疾病的治疗作用。IgG作用机制梳理跟静丙相比，皮丙具有耐受性好、不良反应发生率低、经济成本低、患者满意度较高、可维持稳定的生理水平的血清IgG浓度、可自我给药、易于患者自我管理等优点，在海外市场被广泛用于多种免疫性疾病治疗。静丙IVIG和皮丙SCIG特征比较此外，皮丙和静丙的药物成本基本相当，但由于皮丙所需医师数量更少、住院就诊次数减少、 所需总护理时间更短，整体治疗成本显著低于静丙。以下图为例，价格各国静丙治疗费用为1，则美国、加拿大、德国皮丙的治疗费用分别仅有静丙的12%、22%和 50%。CSL的皮丙和静丙产品每单位价格相当各国皮丙和静丙治疗费用比较从适应症来看，皮丙目前获批的适应症少于静丙，更聚焦于慢性替代治疗。静丙IVIG和皮丙SCIG获批适应症比较根据Precedence Research预测，从2025年到2034年，免疫球蛋白（静丙+皮丙）市场复合增速预计为7.2%， 其中皮丙将成为增速最快的细分市场。2024年全球血制品市场细分领域情况截止目前，全球获批上市的皮下注射人免疫球蛋白血液制品主要有 HIZENTRA、CUVITRU、XEMBIFY(均为商品名)，其中HIZENTRA于2010年获FDA批准上市；CUVITRU于2016年在荷兰获批上市；XEMBIFY于2019年获FDA批准上市。由于境内禁止境外的皮下注射人免疫球蛋白血液制品在境内申请上市，境内也暂无企业获批上市皮下注射人免疫球蛋白，因此境内尚无皮下注射人免疫球蛋白上市产品。从研发进展来看，天坛生物的皮下注射人免疫球蛋白已于2024年底申报上市并获受理，有望于2026年底前获批。此外，远大蜀阳于2024年7月启动临床，博雅生物于2025年1月启动临床，华兰生物于2022年开展临床前研究，其余血制品龙头公司并未披露其皮下注射人免疫球蛋白研发进展，天坛生物的领先优势显著。国内皮下注射人免疫球蛋白临床研发进展识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

Grifols' Cairo project is part of a national initiative to achieve self-sufficiency in plasma-derived medicines. Grifols & Orange Business Complete landmark phase of Data Centre for Plasma Derivatives Facility, designed to boost healthcare in Egypt Global healthcare company Grifols is working with French telecoms giant Orange to create a sustainable supply of essential therapeutics for life-threatening diseases in Egypt. Orange Business –  the enterprise division of telecoms company, Orange Group – has completed the initial stage of a new data centre and communications infrastructure in Cairo, for Grifols Egypt for Plasma Derivatives (GEPD). GEPD is a joint venture between Grifols and Egypt's National Service Projects Organisation (NSPO), which manufactures military and civilian products and provides contracting services. The project is part of a national initiative to achieve self-sufficiency in plasma-derived medicines -- vital treatments extracted from blood plasma for various serious medical conditions. Partnership to boost Egyptian healthcare Grifols, a specialist in plasma-derived medicines, is seeking to interconnect critical healthcare facilities, including a plasma laboratory, co-location data centre, plasma warehouse, 20 plasma donation centres, and a state-of-the-art manufacturing facility. Orange Business is providing co-location services, which allows GEPD to house its servers in Orange's data centre. The company is also supplying communication services and support with equipment procurement. The networked healthcare infrastructure is designed to ensure efficient operations and “the timely delivery of plasma-derived medicines to patients in need”, said Dr Ahmed Serag, Chief Strategy and Projects Officer at GEPD. Kristof Symons, CEO International at Orange Business, said: "Our technical skills, experienced resources, and global knowledge were pivotal in enabling Grifols to replicate its global business model in Egypt. This project shows how Orange Business can support its customers in creating a positive impact in today's society." About Grifols Multinational healthcare company Grifols was founded in 1940 in Barcelona, Spain employs 24,000 people worldwide, and specialises in the production of plasma-derived medicines and the development of diagnostic solutions. Its core activities include plasma collection, the manufacture of protein therapies derived from plasma, and fractionation, a process that separates a mixture into two or more fractions with different chemical and physical properties. Grifols is conducting clinical trials for its Alzheimer's treatment , a plasma-based therapy aimed at slowing cognitive decline in patients with mild to moderate Alzheimer's disease. The company is also researching treatments for liver diseases and immunodeficiencies. Among Grifols' products are Gamunex, an immune globulin therapy used to treat primary immunodeficiency, and Prolastin, used in the treatment of alpha-1 antitrypsin deficiency. The firm also produces albumin solutions for fluid replacement and coagulation factors for haemophilia treatment. In the diagnostic sector, Grifols offers blood typing systems and infectious disease screening tools. The company operates a network of plasma donation centres, primarily in the US, which form a crucial part of its supply chain for plasma-derived therapies.