(6月13日)东京Chugai药业公司宣布其用于治疗Castleman病的人源化IL-6受体单克隆抗体Tocilizumab(基因重组)注射剂(商品名为：静脉注射剂ACTEMRA®200)，该名简称ACTEMRA®，正式投入生产。

据日本媒体4月14日消息，中外制药13日称，厚生劳动省已批准其生产首种国产化的抗体药物小知识：药物，经由过程口服、静脉点滴、动脉介入、外贴、肛门塞入、雾化吸入等多种路子年夜剂量给药，在短时间内使血液药物浓度迅速增添，以达到医治目标。这类疗法具有时间短、无痛苦、生效快等特性。经由过程上述的介绍，对于肝癌复发能活多久相信您以已经有了必然的体味了。积极医治，为安康保驾护航。关头词：肝癌复发能活多久...人源化IL-6受体单克隆抗体(Tocilizumab)——用于治疗罕见病Castleman’s disease。

据悉，Castleman为淋巴增殖性疾病，尽管致病因小知识：病因医治药、辅助医治药、症状医治药。在医治的同时呵护患者身体机能，力图带来综合周全的疗效。拟定直肠癌术后化疗方案，我们主张中中医连络医治癌症。即手术、放化疗并共同中药。适宜手术的尽可能手术；不适宜手术的，适合放化疗的可以用放化疗和王牌系列抗癌药同时利用；若是体质较差或对放化疗不敏感的，可在大夫指导下单用王牌系列抗癌药进行医治，有的病人可利用“冲击疗法”，以使病人达到改善症状、减轻痛苦、延永生命，提离生存质量的疗效。选择直肠癌术后化疗方案，就选中中医连络冲击疗法。该疗法对症医治，因人而异，对患者生存质量的提高有很年夜帮忙。关头词：直肠癌术后化疗方案选择好的直肠癌术后化疗方案其实不是一件容易的事。直肠癌术后化疗方案属于一种局部的医治手段，为将化疗的反作用降到最低点，比来几年来中药加入医治，与放化疗等手段有机连络多路子综合医治编制医治肿瘤，对有效节制症状有较好作用。患者需求在具体扣问大夫这些方案的优错误谬误之...尚未明了，但可能与IL-6的过剩分泌相关。Tocilizumab具有抑制IL-6与其受体结合的作用，可用于无法手术的患者人群。

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Actemra® - Worlds First Drug for Castlemans Disease - Launched in Japan

Category: Public Health News

Article Date: 13 Jun 2005

Tokyo - Chugai Pharmaceutical Co., Ltd [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereinafter, Chugai)] announced that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, tocilizumab (genetical recombination) injection - trade name: "ACTEMRA® 200 for Intravenous Infusion" (hereinafter, "ACTEMRA®") - for the treatment of Castlemans disease*1, was launched today.

"ACTEMRA®" is a humanized monoclonal antibody co-developed by Osaka University and Chugai utilizing genetic recombinant technology. In order to meet the medical needs such as the development of new therapies targeting more specific disease process, Chugai completed the clinical development in a short period after receiving the orphan drug designation for Castlemens Disease in December 2000. The NDA for Castlemans disease was filed in April 2003 and was approved on April 11, 2005 as the first monoclonal antibody drug manufactured in Japan. The price was listed on the National Health Insurance reimbursement price list on June 3, 2005.

The price was set at 59,879 yen per vial.

"ACTEMRA®" is the worlds first drug approved for Castlemans disease. Chugai estimates that approximately 1,500 patients are diagnosed as Castlemans disease in Japan. It is further estimated that among these patients, over 100 patients who cannot be treated by surgery and show resistance to traditional therapies are subject to ACTEMARA treatment. Castlemans disease was first reported by Dr. Benjamin Castleman (MD) in 1956 and is a very rare lymphoproliferative disease characterized by symptoms such as systemic lymphadenopathy, fever, general fatigue, weight loss, anemia, splenomegaly, hepatomegaly, and various abnormal laboratory test values. Conditions such as amyloidosis, hemolytic anemia, or interstitial pneumonia have been reported as complications of the disease. The pathology and symptoms of Castlemans disease result from the excessive production of IL-6. "ACTEMRA®" has been proved through clinical trial to improve the symptoms and abnormal laboratory test values by suppressing the biological activity of IL-6.

Thirty five patients with Castlemans disease received 8 mg/kg of "ACTEMRA®" eight times in total with two-week intervals in the Phase II study, which resulted in significant improvements in inflammation markers (increased C reactive protein, increased fibrinogen, increased erythrocyte sedimentation rate), general malaise, anemia, and hypoalbuminemia. In the subsequent long-term extension study (treatment period: maximum 1,568 days, average 1,191 days) the therapeutic effect such as improvement of the inflammation markers was maintained with good tolerability.

The major adverse events were nasopharyngitis (88.6%); skin rash (48.6%); abdominal pain (31.4%); itching (28.6%); and neutropenia (25.7%). As the condition for approval*2 all patients treated with "ACTEMRA®" will be required to be monitored for efficacy and safety.

Chugai wishes that the introduction of this drug brings increased benefits to patients who are refractory to conventional therapies such as corticosteroids.

Reference

Generic name: Tocilizumab (Genetical Recombination)

Trade name: ACTEMRA® 200 for Intravenous Infusion

*1Indications: Improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein,fibrinogen, and erythrocyte sedimentation rate,decreased haemoglobin and albumin) associated with Castlemans disease. However, treatment with ACTEMRA® should be limited to patients for whom lymph node resection is not indicated.

Dosage and Administration:

The recommended dose of tocilizumab (genetical recombination) is 8 mg/kg as a single intravenous drip infusion administered at 2-week intervals. The dosing interval may be shortened to 1 week as minimum depending on the patients condition.

*2Condition for approval:

During the reexamination period, all patients treated with ACTEMRA® should be registered as subjects, and investigations about efficacy and safety including change of lymph node swelling and effect on progression of complications should be conducted. At the same time, information about efficacy and safety of long term treatment with ACTEMRA® should be collected.

Date of listing in the NHI reimbursement price: June 3, 2005

Date of initial marketing in Japan: June 13, 2005

Expiration date: 2 years

NHI price: ACTEMRA® 200 for Intravenous Infusion: 59,879 yen per vial