OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

日本大阪和马萨诸塞州剑桥。-（商业新闻短讯）--武田（东京证交所：4502/纽约证交所：TAK）今天宣布，欧盟委员会（EC）批准HYQVIA®[用重组人透明质酸酶输注10%（人）免疫球蛋白]作为静脉注射免疫球蛋白治疗（IVIG）稳定后所有年龄段慢性炎性脱髓鞘性多发性神经病（CIDP）患者的维持治疗。

Takeda previously announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 15, 20231 and approval as a maintenance therapy for adults with CIDP by the U.S. Food and Drug Administration on January 16, 2024.2.

武田此前于20231年12月15日宣布了人类使用药品委员会（CHMP）的积极意见，并于2024年1月16日被美国食品和药物管理局批准为CIDP成人维持治疗。

As the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, HYQVIA offers the potential for patients to infuse up to once monthly (every two, three or four weeks), as the hyaluronidase component facilitates the dispersion and absorption of large immunoglobulin (IG) volumes in the subcutaneous space between the skin and the muscle.

作为CIDP的第一个也是唯一一个促进皮下免疫球蛋白（fSCIG），HYQVIA为患者提供了每月一次（每两周、三周或四周）输注的潜力，因为透明质酸酶成分有助于大免疫球蛋白（IG）在皮肤和肌肉之间的皮下空间中的分散和吸收。

HYQVIA can be administered by a healthcare professional or self-administered in the comfort of a patient’s own home after appropriate training.3.

HYQVIA可以由医疗保健专业人员管理，也可以在经过适当培训后在患者自己的家中舒适地自行管理。

“Following the FDA approval of the HYQVIA CIDP indication in January 2024, the EC’s approval of HYQVIA for CIDP is a critical step towards giving people in the EU living with CIDP access to a maintenance treatment with proven efficacy that can be administered up to once monthly, at-home or in-office,” said Kristina Allikmets, senior vice present and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit.

克里斯蒂娜·阿利克梅茨（KristinaAllikmets）说：“在2024年1月FDA批准HYQVIA CIDP适应症后，欧盟委员会批准HYQVIA用于CIDP是朝着让欧盟CIDP患者获得经证明有效的维持治疗迈出的关键一步，这种治疗可以每月在家中或办公室进行一次。”，武田血浆衍生疗法业务部门高级副总裁兼研发主管。

“This expanded indication for HYQVIA also reflects Takeda’s commitment to bring the benefits of our immunoglobulin therapies to people with neuroimmunological disorders and provide treatment options that have the potential to positively impact their lives and elevate the standard of care.”.

“这一扩大的HYQVIA适应症也反映了武田致力于将我们的免疫球蛋白疗法的益处带给神经免疫疾病患者，并提供有可能对他们的生活产生积极影响并提高护理标准的治疗选择。”。

CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in the extremities.4 The role of IG therapy for this rare, debilitating and slowly progressing or relapsing disease has been well-established5 and is considered a standard of care for this complex and heterogeneous condition in guidelines from the European Academy of Neurology and Peripheral Nerve Society due to its broad immunomodulatory and anti-inflammatory effects.6.

CIDP是一种获得性免疫介导的疾病，影响周围神经系统，其特征是远端和近端肢体进行性对称无力，四肢感觉功能受损。4 IG治疗对这种罕见疾病的作用，由于其广泛的免疫调节和抗炎作用，衰弱和缓慢进展或复发的疾病已被确立[5]，并且在欧洲神经病学和周围神经学会的指南中被认为是治疗这种复杂和异质性疾病的标准。

This approval is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 trial, which was a multicenter, placebo-controlled, double-blinded study that evaluated the efficacy and safety of HYQVIA as a maintenance therapy to prevent relapse in patients with CIDP. The global study included 132 adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of IVIG therapy for at least three months prior to screening.

该批准基于关键的3期ADVANCE-CIDP 1试验的数据，该试验是一项多中心，安慰剂对照，双盲研究，评估了HYQVIA作为预防CIDP患者复发的维持治疗的有效性和安全性。这项全球研究包括132名确诊为CIDP的成年人，他们在筛查前至少三个月一直保持IVIG治疗的稳定给药方案。

Results showed a clinically significant reduction in CIDP relapse rate with HYQVIA versus placebo 15.5% (95% CI: 8.36, 26.84) in the HYQVIA and 31.7% (95% CI: 21.96, 43.39) in the placebo groups. The treatment difference was -16.2 (95% CI: -29.92, -1.27), favoring HYQVIA over placebo.3.

结果显示，与安慰剂组相比，HYQVIA组CIDP复发率临床显着降低，HYQVIA组为15.5%（95%CI:8.36,26.84），安慰剂组为31.7%（95%CI:21.96,43.39）。治疗差异为-16.2（95%CI：-29.92，-1.27），优于安慰剂。

While adverse events (AEs) were more frequent with HYQVIA (79.0% of patients) than placebo (57.1%), severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common. The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae. The most common (reported in >5% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema.

虽然HYQVIA（79.0%的患者）的不良事件（AE）比安慰剂（57.1%）更频繁，但严重（1.6%比8.6%）和严重AE（3.2%比7.1%）不太常见。大多数AE是轻度或中度的，局部的，不需要停止输注，并且没有后遗症。最常见的（在>5%的患者中报告）因果相关的AE包括头痛和恶心，以及局部AE，包括输液部位疼痛，红斑，瘙痒和水肿。

7 Overall, the safety profile observed in the ADVANCE-CIDP 1 trial was generally consistent with the existing EU Summary of Product Characteristics (SmPC).3.

7总体而言，ADVANCE-CIDP 1试验中观察到的安全性概况与现有的欧盟产品特性总结（SmPC）基本一致。

The centralized marketing authorization for HYQVIA in CIDP is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland. HYQVIA first received approval from the EC for the treatment of primary immunodeficiency (PID) in 2013 as well as secondary immunodeficiency (SID) in 2020.8.

HYQVIA在CIDP的集中营销授权在所有欧盟成员国以及冰岛、列支敦士登、挪威和北爱尔兰均有效。HYQVIA于2013年首次获得EC批准用于治疗原发性免疫缺陷（PID），并于2020年获得继发性免疫缺陷（SID）。

About HYQVIA®

关于HYQVIA®

HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (IG) and is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L.

HYQVIA®[用重组人透明质酸酶输注10%（人）免疫球蛋白]是一种含有重组人透明质酸酶和免疫球蛋白（IG）的液体药物，已被欧洲药品管理局（EMA）批准作为成人替代疗法，患有原发性免疫缺陷（PI）和继发性免疫缺陷（SID）的儿童和青少年，他们患有严重或反复感染，抗菌治疗无效，并且经证实的特异性抗体衰竭（PSAF）或血清IgG水平低于4 g/L。

In addition, it is approved by the EMA as maintenance therapy in adults, children and adolescents (0-18 years) with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG). In the United States it is approved to treat adults and children two years of age and older with PI as a well as a maintenance therapy for adult patients with CIDP.

此外，在静脉注射免疫球蛋白治疗（IVIG）稳定后，它被EMA批准为成人，儿童和青少年（0-18岁）慢性炎性脱髓鞘性多发性神经病（CIDP）的维持治疗。在美国，它被批准用于治疗患有PI的成人和两岁及以上的儿童，以及成年CIDP患者的维持治疗。

HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains IG collected from human plasma. IG are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle.

HYQVIA在皮肤下注入脂肪皮下组织。HYQVIA含有从人血浆中收集的IG。IG是维持身体免疫系统的抗体。HYQVIA的透明质酸酶部分促进IG在皮肤和肌肉之间的皮下空间中的分散和吸收。

HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI)..

HYQVIA每月最多输注一次（CIDP每两周、三周或四周一次；PI每三周或四周一次）。。

About the ADVANCE Clinical Program

关于ADVANCE临床计划

ADVANCE-CIDP 1 was a Phase 3, multicenter, placebo-controlled, double-blinded study to evaluate the efficacy, safety and tolerability of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as a maintenance therapy to prevent relapse in chronic inflammatory demyelinating polyneuropathy (CIDP).

ADVANCE-CIDP 1是一项3期多中心安慰剂对照双盲研究，旨在评估HYQVIA®[用重组人透明质酸酶输注10%（人）免疫球蛋白]作为预防慢性炎症性脱髓鞘性多发性神经病（CIDP）复发的维持疗法的疗效，安全性和耐受性。

The global study included 132 adults with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to screening..

这项全球研究包括132名确诊为CIDP的成年人，他们在筛查前至少三个月一直保持静脉注射免疫球蛋白（IVIG）治疗的稳定给药方案。。

The primary endpoint of the clinical trial was the proportion of subjects who experienced a worsening of functional disability, defined as an increase of ≥1 point relative to the pre-subcutaneous (SC) treatment baseline score in two consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores.

临床试验的主要终点是经历功能障碍恶化的受试者的比例，定义为在连续两次调整的炎性神经病原因和治疗中相对于皮下前（SC）治疗基线评分增加≥1分（INCAT）残疾评分。

The primary efficacy analysis compared relapse rates using a continuity-corrected χ2 test conducted at the 5% level of statistical significance, with missing data imputed as no relapse. Some of the secondary endpoints included time to relapse as defined by relapse probability, effect on activities of daily living (ADL), safety and tolerability.

主要疗效分析使用连续性校正的χ2检验比较了复发率，该检验在5%的统计学显着性水平上进行，缺失数据被认为没有复发。一些次要终点包括复发概率定义的复发时间，对日常生活活动（ADL）的影响，安全性和耐受性。

Patients were randomized to receive either HYQVIA or placebo at the same dose and infusion frequency as their prior IVIG treatment (every two, three or four weeks) for six months or until relapse. Patients who relapsed were offered IVIG treatment as rescue therapy for a period of up to six months. Those who remained relapse free were offered to continue HYQVIA treatment as part of ADVANCE-CIDP 3, an open-label extension clinical trial to assess the long-term safety, tolerability and immunogenicity of HYQVIA in participants with CIDP who completed ADVANCE-CIDP 1..

患者被随机分配接受HYQVIA或安慰剂，剂量和输注频率与之前的IVIG治疗（每两周，三周或四周）相同，持续六个月或直至复发。复发的患者接受IVIG治疗作为抢救治疗，为期长达六个月。作为ADVANCE-CIDP 3的一部分，那些没有复发的患者被提供继续进行HYQVIA治疗，ADVANCE-CIDP 3是一项开放标签的扩展临床试验，用于评估完成ADVANCE-CIDP 1的CIDP参与者中HYQVIA的长期安全性，耐受性和免疫原性。。

Further information about the ADVANCE-CIDP 1 clinical trial is available at ClinicalTrials.gov under study identifier NCT02549170.

有关ADVANCE-CIDP 1临床试验的更多信息，请访问ClinicalTrials.gov，研究标识符为NCT02549170。

HyQvia® (Human normal immunoglobulin) 100 mg/ml solution for infusion for subcutaneous use PRESCRIBING INFORMATION

HyQvia®（人正常免疫球蛋白）100 mg/ml皮下输液溶液处方信息

Always refer to the Summary of Product Characteristics (SmPC) and the local prescribing information of your country before prescribing.

在开处方之前，请务必参阅产品特性摘要（SmPC）和您所在国家的当地处方信息。

Presentation: HyQvia is a dual vial unit consisting of one vial of 10% human normal immunoglobulin (Ig) and one vial of recombinant human hyaluronidase (see the SmPC for details).

介绍：HyQvia是一种双瓶装置，由一瓶10%人正常免疫球蛋白（Ig）和一瓶重组人透明质酸酶组成（详见SmPC）。

Indications: Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes (PID) with impaired antibody production; secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/l.

适应症：成人，儿童和青少年（0-18岁）的替代疗法：抗体产生受损的原发性免疫缺陷综合征（PID）；患有严重或反复感染，抗菌治疗无效且经证实的特异性抗体衰竭（PSAF）或血清IgG水平低于4 g/l的患者的继发性免疫缺陷（SID）。

PSAF is a failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in: chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg..

PSAF未能使肺炎球菌多糖和多肽抗原疫苗的IgG抗体滴度至少提高2倍。成人，儿童和青少年（0至18岁）的免疫调节治疗：慢性炎症性脱髓鞘性多发性神经病（CIDP）作为IVIg稳定后的维持治疗。。

Dosage and administration: For subcutaneous use only. Therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency/CIDP. The product should be brought to room temperature before use. Inspect both vials for discolouration and particulate matter before administration.

剂量和给药：仅供皮下使用。治疗应在免疫缺陷/CIDP治疗经验丰富的医生的监督下开始和监测。使用前应将产品置于室温。给药前检查两个小瓶是否变色和颗粒物质。

Do not use heating devices including microwaves. Do not shake or mix the components of the two vials. Suggested infusion site(s) are the middle to upper abdomen and thighs. The two components of the medicinal product must be administered sequentially through the same needle beginning with the recombinant human hyaluronidase followed by Ig 10%.

不要使用加热设备，包括微波炉。不要摇动或混合两个小瓶的成分。建议的输液部位是中上腹和大腿。药品的两种成分必须通过相同的针依次给药，从重组人透明质酸酶开始，然后是Ig 10%。

Please see the SmPC for infusion rates. The full contents of the recombinant human hyaluronidase vial should be administered regardless of whether the full contents of the Ig 10% vial is administered. Longer needles may be used under medical supervision to prevent infusion site leakage. Home treatment should be initiated and monitored by a physician experienced in the guidance of patients for home treatment.

有关输注速率，请参阅SmPC。无论是否施用Ig 10%小瓶的全部内容物，都应施用重组人透明质酸酶小瓶的全部内容物。在医疗监督下可以使用更长的针头，以防止输液部位泄漏。家庭治疗应由在指导患者进行家庭治疗方面经验丰富的医生发起和监测。

Posology: Dose and dosage regimen may need to be individualised for each patient dependent on the response. The dose and dose regimens are dependent on the indication. Dose based on body weight may require adjustment in underweight or overweight patients. Replacement therapy in PID: Patients naïve to Ig therapy: The dose required to achieve a trough level of 6 g/L is approximately 0.4-0.8 g/kg body weight/month.

体位学：剂量和剂量方案可能需要根据反应针对每位患者进行个性化。剂量和剂量方案取决于适应症。体重不足或超重患者可能需要根据体重调整剂量。PID的替代疗法：未接受Ig治疗的患者：达到6 g/L谷值所需的剂量约为0.4-0.8 g/kg体重/月。

The dose interval to maintain steady state levels varies from 2-4 weeks. IgG trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels (>6 g/l). At t.

维持稳态水平的剂量间隔为2-4周。应结合感染发生率测量和评估IgG谷水平。为了降低感染率，可能有必要增加剂量并以更高的谷值（>6 g/l）为目标。在t。

Contraindications: Hypersensitivity to any ingredient or human IG especially in patients with antibodies against IgA; systemic hypersensitivity to hyaluronidase or human recombinant hyaluronidase; HyQvia must not be given IV or intramuscularly.

禁忌症：对任何成分或人IG过敏，尤其是对IgA抗体患者；对透明质酸酶或人重组透明质酸酶的系统性超敏反应；HyQvia不得静脉注射或肌肉注射。

Warnings and precautions: If HyQvia is accidentally administered into a blood vessel, patients could develop shock. The recommended infusion rate given in the SmPC should be adhered to. Infuse slowly and monitor closely throughout the infusion period, particularly patients starting therapy. Patients may require monitoring for up to 1 hour after administration.

警告和注意事项：如果HyQvia意外进入血管，患者可能会出现休克。应遵循SmPC中给出的推荐输注速率。缓慢输注并在整个输注期间密切监测，尤其是开始治疗的患者。给药后患者可能需要监测长达1小时。

Manage infusion related events by slowing the infusion rate or stopping the infusion. Treatment will depend on the nature and severity of the adverse event. Patients should be reminded to report chronic inflammation and nodules which occur at the infusion site or other locations. For home treatment, patients should have the support of another responsible person in case of adverse reactions.

通过减慢输液速度或停止输液来管理输液相关事件。治疗将取决于不良事件的性质和严重程度。应提醒患者报告输液部位或其他部位发生的慢性炎症和结节。对于家庭治疗，如果出现不良反应，患者应该得到另一位负责人的支持。

Record treatment with HyQvia and batch number in patients’ notes..

在患者笔记中记录HyQvia治疗和批号。。

Hypersensitivity: Hypersensitivity reactions are possible in patients with anti-IgA antibodies who should only be treated with HyQvia if alternative treatments are not possible and under close medical supervision. In case of hypersensitivity, shock or anaphylactic-like reactions, discontinue the infusion immediately and treat the patient for shock.

超敏反应：抗IgA抗体患者可能出现超敏反应，只有在不可能替代治疗且在密切的医疗监督下，才应使用HyQvia治疗。如果出现超敏反应、休克或类似过敏反应，应立即停止输注，并对患者进行休克治疗。

Rarely, human normal IG can induce a fall in blood pressure with anaphylactic reaction. In high-risk patients HyQvia should only be administered where supportive care is available for life threatening reactions. Patients should be informed of the early signs of anaphylaxis/ hypersensitivity. Pre-medication may be used as a preventative measure..

很少，人类正常IG会引起血压下降并产生过敏反应。在高危患者中，只有在对危及生命的反应提供支持治疗的情况下才能使用HyQvia。应告知患者过敏反应/超敏反应的早期迹象。用药前可作为预防措施。。

Hypersensitivity to recombinant human hyaluronidase: Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary.

对重组人透明质酸酶的超敏反应：重组人透明质酸酶给药后，任何怀疑过敏或过敏样反应的人都需要立即停止输注，必要时应进行标准药物治疗。

Immunogenicity of recombinant human hyaluronidase: Development of non-neutralising antibodies and neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies.

重组人透明质酸酶的免疫原性：在临床研究中，接受HyQvia的患者已经报道了针对重组人透明质酸酶成分的非中和抗体和中和抗体的开发。

Thromboembolism: Thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been observed with IG treatment and cannot be excluded with use of HyQvia. Ensure adequate hydration prior to treatment. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk.

血栓栓塞：IG治疗已观察到血栓栓塞事件，包括心肌梗塞，中风，深静脉血栓形成和肺栓塞，并且不能排除使用HyQvia。治疗前确保充分水合。监测血栓形成的体征和症状，并评估高危患者的血液粘度。

Patients should be informed about initial symptoms and advised to contact their physician immediately upon onset..

应告知患者最初的症状，并建议患者在发病后立即联系医生。。

Haemolytic anaemia: IG products contain antibodies to blood groups (e.g. A, B, D) which may act as haemolysins. Monitor for signs and symptoms of haemolysis.

溶血性贫血：IG产品含有可能作为溶血素的血型抗体（例如A，B，D）。监测溶血的体征和症状。

Aseptic meningitis syndrome: has been reported, symptoms usually begin within several hours to 2 days following treatment. Patients should be informed about initial symptoms. Discontinuation of IG treatment may result in remission within several days without sequelae.

无菌性脑膜炎综合征：据报道，症状通常在治疗后数小时至2天内开始。应告知患者最初的症状。停止IG治疗可能会在几天内缓解而没有后遗症。

Interference with serological testing: After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results in serological testing. Passive transmission of antibodies to erythrocyte´s surface antigens may interfere with some serological tests for red cell antibodies.

干扰血清学检测：输注免疫球蛋白后，患者血液中各种被动转移抗体的短暂升高可能导致血清学检测产生误导性的阳性结果。针对红细胞表面抗原的抗体的被动传播可能会干扰红细胞抗体的某些血清学测试。

Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of β-D glucans for diagnosis of fungal infections..

在依赖于检测β-D葡聚糖来诊断真菌感染的测定中，输注免疫球蛋白产品可能导致假阳性读数。。

Transmissible agents: Infectious diseases due to the transmission of infective agents cannot be totally excluded.

传染性病原体：不能完全排除由传染性病原体传播引起的传染病。

Sodium content: The recombinant human hyaluronidase component contains 4.03 mg sodium/mL. To be taken into consideration by patients on a controlled sodium diet.

钠含量：重组人透明质酸酶成分含有4.03毫克钠/毫升。由控制钠饮食的患者考虑。

Traceability: The name and the batch number of the administered product should be clearly recorded.

可追溯性：应清楚记录管理产品的名称和批号。

Interactions: Live attenuated virus vaccines – postpone vaccination for 3 months after treatment with HyQvia. For measles vaccine, impairment may persist for up to 1 year, so check antibody status. Please see the SmPC for details.

相互作用：减毒活疫苗-用HyQvia治疗后推迟接种3个月。对于麻疹疫苗，损伤可能持续长达1年，因此请检查抗体状态。有关详细信息，请参阅SmPC。

Fertility, pregnancy and lactation: Safety during pregnancy has not been established and immunoglobulins are excreted into the milk, therefore use with caution in pregnant and breastfeeding mothers.

生育，怀孕和哺乳期：怀孕期间的安全性尚未确定，免疫球蛋白会排泄到牛奶中，因此孕妇和哺乳期母亲应谨慎使用。

Effects on ability to drive and use machines: The ability to drive and operate machines may be impaired by some adverse reactions e.g., dizziness associated with this medicinal product. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines..

对驾驶和使用机器能力的影响：驾驶和操作机器的能力可能会受到一些不良反应的影响，例如与该药品相关的头晕。在治疗期间出现不良反应的患者应在驾驶或操作机器之前等待这些反应的解决。。

Undesirable effects: Very common (≥1/10 patients): Headache, Blood pressure increased and Hypertension, Nauseam Diarrhoea, Vomiting, Arthralgia, Local reactions (Infusion site discomfort, Infusion site pain, Injection site pain, Puncture site pain and Tenderness; infusion site erythema and Injection site erythema; Infusion site oedema, Injection site oedema, infusion site swelling, Injection site swelling and Swelling (local), Feeling hot, Asthenia, Fatigue, Lethargy and Malaise..

不良反应：非常常见（≥1/10患者）：头痛，血压升高，高血压，恶心腹泻，呕吐，关节痛，局部反应（输液部位不适、输液部位疼痛、注射部位疼痛、穿刺部位疼痛和压痛；输液部位红斑和注射部位红斑；输液部位水肿、注射部位水肿、输液部位肿胀、注射部位肿胀和肿胀（局部），感觉热、乏力、疲劳、嗜睡和不适。。

Common (≥1/100, <1/10 patients): Migraine, Tremor, Paraesthesia, Sinus tachycardia and Tachycardia, Hypotension, Dyspnoea, Abdominal distension, Erythema, Pruritus, Rash, Rash erythematous, Rash macular, Rash maculo-papular and Rash popular Urticaria, Myalgia, Limb discomfort and Pain in extremity, Back pain, Joint stiffness, Musculoskeletal chest pain, Groin pain, Hemosiderinuria, Infusion related reaction, Infusion site bruising, Injection site bruising, Infusion site haematoma, Injection site haematoma, Infusion site haemorrhage and Vessel puncture site bruise, Infusion site reaction, Injection site reaction and Puncture site reaction, Infusion site mass, Injection site mass and Infusion site nodule, Infusion site discoloration, Infusion site rash and Injection site rash, Infusion site induration and Injection site induration, Infusion site warmth, Infusion site paraesthesia and Injection site paraesthesia, Infusion site inflammation, Chills, Oedema, Oedema peripheral and Swelling (systemic), Localised oedema, Peripheral swelling and Skin oedema, Gravitational oedema, Oedema genital, Scrotal swelling and Vulvovaginal swelling, Hyperhidrosis, Coombs direct test positive and Coombs test positive..

常见（≥1/100，<1/10患者）：偏头痛，震颤，感觉异常，窦性心动过速和心动过速，低血压，呼吸困难，腹胀，红斑，瘙痒，皮疹，皮疹红斑，皮疹黄斑，皮疹斑丘疹和皮疹流行性荨麻疹，肌痛，肢体不适和四肢疼痛，背痛，关节僵硬，肌肉骨骼胸痛，腹股沟痛，含铁血黄素尿，输液相关反应，输液部位瘀伤，注射部位瘀伤，输液部位血肿，注射部位血肿，输液部位出血和血管穿刺部位瘀伤，输液部位反应，注射部位反应和穿刺部位反应，输液部位肿块，注射部位肿块和输液部位结节，输液部位变色，输液部位皮疹和注射部位皮疹，输液部位硬结和注射部位硬结，输液部位温暖，输液部位感觉异常和注射部位感觉异常，输液部位炎症，寒战，水肿，水肿外周和肿胀（全身），局部水肿，外周肿胀和皮肤水肿，重力性水肿，生殖器水肿，阴囊肿胀和外阴阴道肿胀，多汗症，Coombs直接测试阳性和Coombs测试阳性。。

Uncommon (≥ 1/1 000 to < 1/100): Cerebrovascular accident and Ischaemic stroke, Burning sensations.

不常见（≥1/1000至<1/100）：脑血管意外和缺血性中风，烧灼感。

Other undesirable effects (rare or unknown frequency): Meningitis aseptic, Hypersensitivity, Direct Coombs’ test positive, Infusion site leakage, Influenza-like illness.

其他不良反应（罕见或未知频率）：无菌性脑膜炎，超敏反应，直接Coombs试验阳性，输液部位渗漏，流感样疾病。

Refer to the SmPC for details on full side effect and interactions.

有关全部副作用和相互作用的详细信息，请参阅SmPC。

Marketing Authorisation (MA) numbers: 2.5g EU/1/13/840/001, 5g EU/1/13/840/002, 10g EU/1/13/840/003, 20g EU/1/13/840/004, 30g EU/1/13/840/005. Name and address of MA holder: Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna, Austria. HyQvia is a registered trade name.

上市许可（MA）编号：2.5g EU/1/13/840/001、5g EU/1/13/840/002、10g EU/1/13/840/003、20g EU/1/13/840/004、30g EU/1/13/840/005。MA持有人的名称和地址：Baxalta Innovations GmbH，Industriestrasse 67，A-1221 Vienna，Austria。HyQvia是一个注册商标名。

PI approval code: PI-02941

PI批准代码：PI-02941

Date of preparation: January 2024.

编制日期：2024年1月。

Further information is available on request.

可根据要求提供更多信息。

Adverse events should be reported to the authorities in your country as required by local law. Adverse events should also be reported to Takeda at: GPSE@takeda.com.

应根据当地法律的要求，向贵国当局报告不良事件。不良事件也应报告给武田：GPSE@takeda.com.

For Full U.S. Prescribing Information, please visit: https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf

有关美国处方的完整信息，请访问：https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf

About Takeda

关于武田

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

武田致力于为人们创造更好的健康，为世界创造更美好的未来。我们的目标是在我们的核心治疗和业务领域发现并提供改变生命的治疗方法，包括胃肠道和炎症、罕见疾病、血浆衍生疗法、肿瘤学、神经科学和疫苗。

Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet.

与我们的合作伙伴一起，我们的目标是通过我们动态多样的渠道改善患者体验，并推进治疗选择的新前沿。作为总部位于日本的领先的基于价值观、研发驱动的生物制药公司，我们以对患者、人民和地球的承诺为指导。

Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com..

我们在大约80个国家和地区的员工是由我们的目标驱动的，并以两个多世纪以来定义我们的价值观为基础。有关更多信息，请访问www.takeda.com。。

Important Notice

重要注意事项

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction.

就本通知而言，“新闻稿”是指武田制药有限公司（“武田”）就本新闻稿讨论或分发的本文件、任何口头陈述、任何问答环节以及任何书面或口头材料。本新闻稿（包括任何口头简报以及与之相关的任何问题和答案）不打算，也不构成、代表或构成在任何司法管辖区内购买、以其他方式获取、认购、交换、出售或以其他方式处置任何证券的任何要约、邀请或邀约的一部分，也不构成任何投票或批准的邀约、邀请或邀约的一部分。

No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction).

本新闻稿不向公众发售任何股份或其他证券。除非根据经修订的《1933年美国证券法》进行登记或获得豁免，否则不得在美国发行证券。本新闻稿（连同可能向接收方提供的任何进一步信息）的发布条件是，本新闻稿仅供接收方参考（不用于评估任何投资、收购、处置或任何其他交易）。

Any failure to comply with these restrictions may constitute a violation of applicable securities laws..

任何不遵守这些限制的行为都可能构成对适用证券法的违反。。

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them.

武田直接和间接拥有投资的公司是独立的实体。在本新闻稿中，通常提及武田及其子公司时，“武田”有时是为了方便起见。同样，“我们”、“我们”和“我们的”也用于指代一般的子公司或为其工作的人。

These expressions are also used where no useful purpose is served by identifying the particular company or companies..

如果识别特定公司没有任何有用的目的，也可以使用这些表达。。

Forward-Looking Statements

前瞻性声明

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof.

本新闻稿和与本新闻稿相关的任何材料可能包含有关武田未来业务、未来地位和经营成果的前瞻性声明、信念或意见，包括武田的估计、预测、目标和计划。不受限制，前瞻性陈述通常包括“目标”，“计划”，“相信”，“希望”，“继续”，“期望”，“目标”，“打算”，“确保”，“将”，“可能”，“应该”，“将”，“可能”，“预期”，“估计”，“项目”或类似表达或其负面影响。

These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to div.

这些前瞻性陈述基于对许多重要因素的假设，包括以下因素，这些因素可能导致实际结果与前瞻性陈述中明示或暗示的结果产生重大差异：围绕武田全球业务的经济情况，包括日本和美国的一般经济状况；竞争压力和发展；适用法律法规的变更，包括全球医疗保健改革；新产品开发固有的挑战，包括临床成功的不确定性以及监管机构的决策及其时间安排；新产品和现有产品商业成功的不确定性；制造困难或延误；利率和货币汇率波动；关于上市产品或候选产品的安全性或有效性的索赔或担忧；健康危机（如新型冠状病毒大流行）对武田及其客户和供应商（包括武田经营所在国的外国政府）或其业务其他方面的影响；与被收购公司进行并购后整合的时机和影响；潜水的能力。

Medical Information

医疗信息

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development..

本新闻稿包含的产品信息可能并非在所有国家都可用，也可能以不同商标、不同适应症、不同剂量或不同强度提供。此处所含内容不应视为任何处方药（包括正在开发的处方药）的招揽、促销或广告。。

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1 Takeda Pharmaceuticals. (2023 December 15). Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Press Release]. Available here. Last accessed January 2024.

1武田制药。（2023年12月15日）。武田对HYQVIA®作为慢性炎症性脱髓鞘性多发性神经病（CIDP）患者的维持治疗获得了积极的CHMP意见[新闻稿]。此处提供。上次访问时间为2024年1月。

2 Takeda Pharmaceuticals. (2024 January 16). U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Press Release]. Available here. Last accessed January 2024.

2武田制药。（2024年1月16日）。U、 美国FDA批准武田的HYQVIA®作为成人慢性炎症性脱髓鞘性多发性神经病（CIDP）的维持治疗[新闻稿]。此处提供。上次访问时间为2024年1月。

3 European Medicines Agency. HyQvia 100 mg/mL solution for infusion for subcutaneous use Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf.

3欧洲药品管理局。HyQvia 100 mg/mL皮下输液溶液产品特性总结。可在https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf.

4 Dalakas MC; Medscape. Advances in the diagnosis, pathogenesis and treatment of CIDP. Nat Rev Neurol. 2011;7(9):507-517.

4达拉喀斯MC；Medscape。CIDP的诊断，发病机制和治疗进展。Nat Rev Neurol。2011年；7（9）：507-517。

5 Eftimov F, et al. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2013;(12):CD001797.

5 Eftimov F等人。静脉注射免疫球蛋白治疗慢性炎性脱髓鞘性多神经根神经病。Cochrane数据库系统2013年版；（12） ：CD001797。

6 Van den Bergh PYK, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision [published correction appears in J Peripher Nerv Syst. 2022 Mar;27(1):94]..

6 Van den Bergh PYK等人。欧洲神经病学学会/周围神经学会慢性炎性脱髓鞘性多发性神经根神经病诊断和治疗指南：联合工作组第二次修订的报告[已发表的更正见J Peripher Nerv Syst。2022年3月；27（1）：94]。。

7 Bril V, et al. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial. J Peripher Nerv Syst. 2023;28(3):436-449.

7 Bril V等人。透明质酸酶促进皮下免疫球蛋白10%作为慢性炎性脱髓鞘性多神经根神经病的维持治疗：ADVANCE-CIDP 1随机对照试验。J外围神经系统。2023年；28（3）：436-449。

8 European Medicines Agency. HyQvia product information. Available here. Last Accessed January 2024

8欧洲药品管理局。HyQvia产品信息。此处提供。上次访问时间：2024年1月