部份中文伊曲珠单抗处方料（仅供参考）
商品名：Alzumab Injection
英文名：Itolizumab
中文名：伊曲珠单抗注射溶液
制造商：Biocon Limited
药品简介 印度推出首创新药：ALZUMAb（Itolizumab）注射剂，这是全球首个抗CD6单克隆抗体，用于治疗慢性斑块型银屑病。 ALZUMAb(Itolizumab)射溶液：每个5毫升的小瓶中都包含25毫克Itolizumab（r-DNA来源）Alzumab注射剂，用于治疗中度至重度牛皮癣。Alzumab的活性成分是Itolizumab。Alzumab注射液通过减少促炎症细胞因子的合成起作用。
作用机理：
T细胞已被发现在自身免疫性疾病中发挥着主导作用，而CD6是一种泛T细胞标记物，涉及T细胞的共刺激、粘附、成熟。Alzumab通过结合CD6，下调T细胞的激活，导致促炎性细胞因子合成的减少，同时通过减少T细胞在炎症部位的浸润，来发挥重要的作用。Alzumab具有的这种独特作用机制，与现有其他疗法相比，提供了卓越的安全性和相似的疗效属性，具有一个长期的缓解期，以及非常低的机会感染率
适应症：
全球首个抗CD6单克隆抗体，用于治疗慢性斑块型银屑病(chronic plaque psoriasis)。银屑病(Psoriasis)俗称牛皮癣，是一种常见的慢性炎症性皮肤病，属于多基因遗传的疾病，多种激发因素(如创伤、感染、药物等)均可能在易感个体中诱发该病。
其他生物制剂，如细胞因子抑制剂，通过作用于前炎症(pro-inflammatory)级联反应的下游发挥作用，Alzumab则作用于上游，抑制细胞因子的合成，从而降低感染率并取得较长的缓解期。
剂型：注射瓶
剂量：25毫克/ 5毫升
包装大小：1瓶
持证人：Biocon Limited
生产许可证：KTK/28D/7/2006
储存和处理
温度：2-8°C
ALZUMAb™ is the World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for the treatment of Psoriasis in India.
- Excellent safety and efficacy profile with very low opportunistic infection rates and longer remission period
- Offers a new treatment option for Psoriasis with a less aggressive dosing regimen and a longer treatment free period, ensuring better patient compliance and convenience
- Is an innovative affordable treatment option with a promise to offer a better quality of life for the patient
- Will provide an effective biologic treatment solution to 1-2% of Indian population suffering from Psoriasis
- ALZUMAb(Itolizumab)has demonstrated preclinical and/clinical evidence in treating other autoimmune diseases like rheumatoid arthritis, psoriatic arthritis and multiple sclerosis.
- Biocon is committed to offering this novel anti-CD6 biologic from India to patients across the globe
Inflammatory autoimmune diseases like Psoriasis, Rheumatoid Arthritis and Multiple Sclerosis require therapeutic intervention to modulate the immune system and alleviate disease symptoms. Autoimmune diseases are chronic in nature and patients require life long treatment. T-Cells found in the immune system which cause these diseases are a natural target for immunomodulation.
Itolizumab is the world’s 'first-in-class' humanized anti-CD6 monoclonal antibody(MAb) that has a unique mechanism of action(MOA)targeting the CD6 pathway.CD6 is a pan T-Cell marker involved in co-stimulation, adhesion and maturation of T-Cells, which have been found to play a leading role in autoimmune diseases. Itolizumab, by binding to CD6, down regulates T-Cell activation, causes reduction in synthesis of proinflammatory cytokines and possibly plays an important role by reducing T-Cell infiltration at sites of inflammation.
Emerging data shows that in addition to Th1, Th17 cells play a critical role in autoimmune diseases. Itolizumab is the world’s first anti-CD6 biologic addressing the Th17 pathway that has completed its 'Lab to Market' journey, making Biocon a front-runner in the race to develop biologics targeting the Th17 pathway.
Unlike other biologics like cytokine inhibitors which act downstream in the pro-inflammatory cascade, Itolizumab acts upstream inhibiting the formation of cytokines, resulting in lower infection rates and longer remission periods.
In addition to the Phase 3 TREAT-PLAQ study, two positive Phase 2a dose finding studies have been conducted one each in rheumatoid arthritis and psoriasis. A total of over 300 patients have been treated with Itolizumab, of these, about 100 patients have received the drug for 52 weeks with encouraging safety and tolerability profile. Itolizumab was approved by Drugs Controller General of India for treatment of Psoriasis in India in 2013.
Biocon has launched Itolizumab as ALZUMAb™for the treatment of psoriasis in India. It is the Second Novel Biologic from Biocon to be introduced for Indian patients.
