化疗止吐透皮贴片善可舒在中国上市 开启CINV全程管理新篇章

2019-03-18 不详 美通社

2019年3月16日,日本苏爱康公司和李氏大药厂(香港)有限公司联合在上海召开了善可舒®(格拉司琼透皮贴片)全国上市会,正式宣告善可舒®在中国上市销售。善可舒®是全球首个且唯一一个止吐类透皮贴片,用于预防需要接受连续3-5天的中度致吐性化疗(MEC)和 / 或高度致吐性化疗(HEC)引起的恶心和呕吐。善可舒®2008年在 FDA 获批后,陆续在20多个国家和地区上市销售,并被国内外多个指南推荐

2019年3月16日,日本苏爱康公司和李氏大药厂(香港)有限公司联合在上海召开了善可舒®(格拉司琼透皮贴片)全国上市会,正式宣告善可舒®在中国上市销售。善可舒®是全球首个且唯一一个止吐类透皮贴片,用于预防需要接受连续3-5天的中度致吐性化疗(MEC)和 / 或高度致吐性化疗(HEC)引起的恶心和呕吐。善可舒®2008年在 FDA 获批后,陆续在20多个国家和地区上市销售,并被国内外多个指南推荐使用。

日本苏爱康公司和李氏大药厂(香港)有限公司联合在上海召开了善可舒全国上市会,正式宣告善可舒在中国上市销售。善可舒是全球首个且唯一一个止吐类透皮贴片,用于预防需要接受连续3-5天的中度致吐性化疗和/或高度致吐性化疗引起的恶心和呕吐。

善可舒®(格拉司琼透皮贴片)中国上市会暨“择善同行 -- CINV 全程规范化管理项目”在上海隆重举行,中国临床肿瘤学会(CSCO)理事长李进教授、中国临床肿瘤学会(CSCO)副理事长秦叔逵教授、马军教授担任本次上市会主席,来自全国各地相关领域的近200名专家学者汇聚一堂,围绕肿瘤支持治疗的现状和发展,化疗引起恶心呕吐(CINV)的诊疗规范、CINV 全程管理临床经验、善可舒国内外临床研究数据等相关热点进行了分享交流。

善可舒上市会现场
善可舒上市会现场

不仅仅代表 CSCO 和基金会,同时作为国内外著名的肿瘤内科专家和中国注册试验的主要研究者(总 PI),秦叔逵教授对于善可舒@在中国的成功上市表示热烈祝贺。他谈到:“如果不釆用积极有效的防治措施,癌症病人在进行化疗等抗癌药物治疗时引起恶心、呕吐的比例高达70%-80%[1],严重影响生存质量,降低病人耐受性和依从性,常常导致抗癌药物减量甚至终止治疗,显著干扰疗效[2]。传统的化疗性恶心呕吐的预防方案,主要是静脉应用短效制剂,血药浓度波动较大,有损于外周血管,且需多次反复给药,很不方便。而善可舒@是具有高科技独特骨架结构的外贴制剂,透皮吸收,无创安全,使用极为方便,特别是定量缓释,防治化疗性恶心呕吐,药效持久,可达7天或以上,每个化疗周期使用一次即可,是临床上癌症病人防治化疗不良反应的新选择。

中国临床肿瘤学会 (CSCO) 副理事长马军教授
中国临床肿瘤学会 (CSCO) 副理事长马军教授

“CINV 全程管理是国内外指南一致提出的 CINV 治疗基本原则[3]-[5]。”马军教授进一步指出,“接受 HEC 和 MEC 化疗的患者,恶心呕吐风险在末剂化疗之后仍将持续3天和2天[3];而对于多日化疗,急性和延迟性呕吐存在重叠,则更需稳定长效的药物选择。善可舒®能满足预期性恶心呕吐,急性 / 延迟性恶心呕吐等不同阶段的患者需求,7天的稳定疗效对整个化疗周期持续预防和保护[6],使 CINV 的全程管理得以实现,使患者在整个化疗周期能安心舒心。”

中国临床肿瘤学会 (CSCO) 副理事长李进教授
中国临床肿瘤学会 (CSCO) 副理事长李进教授

李进教授提出:“善可舒的成功上市为中国化疗患者预防恶心呕吐提供了疗效持久稳定、无创的给药新途径。作为预防和治疗化疗相关呕吐的又一种选择,轻松一贴,简易方便,使得 CINV 全程管理更趋便捷化,有助于提高临床 CINV 的规范化诊疗,进一步提高 CINV 的治疗效果。”

苏爱康 / 李氏在 CSCO-SCRC 支持下共同打造的“择善同行 -- CINV 全程规范化管理项目也在此次会议上隆重启动。“择善同行”旨在推动 CINV 的规范化治疗,提高 CINV 的控制率,切实改善患者生存质量。项目通过院内宣教、院外关爱热线、患者在线全程管理日记等,帮助患者了解疾病知识,感受全程关爱,获得及时的帮助和支持。同时,帮助医生建立 CINV 全程管理数据库,实时跟踪患者 CINV 的发生发展,对严重呕吐提供及时反馈,优化后续治疗方案。以患者自我报告(PRO)收集的 CINV 现状数据,将为 CINV 的规范化管理提供依据和指导方向。项目受到领域内专家的支持与肯定,全国二十多家中心将参与其中,共同助力 CINV 全程规范化管理。

苏爱康首席执行官荒井好裕先生在会议中表示:“苏爱康始终坚持以患者为中心,旨在开发肿瘤治疗及支持治疗领域的创新药物。秉承将高质量的药物推向市场的理念,造福于中国、日本及其他亚洲国家。善可舒®在中国成功上市,并由苏爱康公司与李氏大药厂共同经销,实现了苏爱康、李氏对中国患者不懈承诺的第一步。苏爱康与李氏的每位成员将以满足患者和专业人员的需求为己任,迎接挑战,不断前行。”

[1] Wiser W, Berger A. Practical management of chemotherapy-induced nausea and vomiting. Oncology (Williston Park). 2005; 19(5): 637-645.

[2] 中国抗癌协会癌症康复与姑息治疗专业委员会;中国临床肿瘤学会抗肿瘤药物安全管理专家委员会. 肿瘤治疗相关呕吐防治指南(2014版).临床肿瘤学杂志 .2014; 19(3): 263-273.

[3] NCCN. Clinical Practice Guidelines in Oncology.  Antiemesis. 2019; Version 1 

[4] Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011; 29(31): 4189-4198.

[5] MASCC/ESMO Antiemetic Guideline

[6] Howell J, Smeets J, Drenth HJ, et al. Pharmacokinetics of a granisetron transdermal system for the treatment of chemotherapy-induced nausea and vomiting. J Oncol Pharm Pract. 2009; 15(4): 223-231.

[7] Boccia RV, Gordan LN, Clark G, et al. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011; 19(10): 1609-1617.

[8] Kim JE, Hong YS, Lee JL, et al. A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients. Support Care Cancer. 2015; 23(6): 1769-1777.

[9] Yang LQ, Sun XC, Qin SK, et al. Transdermal granisetron for the prevention of nausea and vomiting following moderately or highly emetogenic chemotherapy in Chinese patients: a randomized, double-blind, phase III study.  Chin Clin Oncol. 2016; 5(6): 79.

关于善可舒®
善可舒®是格拉司琼透皮贴片,用于预防中度和/或高度致吐性化疗引起的恶心和呕吐。每张52平方厘米的贴片含有34.3mg格拉司琼,每24小时释放3.1mg格拉司琼,释放长达7天。格拉司琼透皮贴片无创给药,疗效持久稳定,安全性良好[7],[8]。目前,善可舒®已在包括美国、英国、德国、荷兰、西班牙、丹麦等20多个国家和地区获批上市。2014年,在中国完成了临床药理学研究和一项随机、双盲、与口服格拉司琼对照的临床研究[9]。2018年7月,成功获得中国国家药品监督管理局(NMPA)的审批。

关于苏爱康
苏爱康根植于亚洲,是一家致力为本地市场开发和销售创新肿瘤治疗药物及肿瘤支持治疗药物的制药公司。苏爱康关注亚洲肿瘤领域系统构建,开发肿瘤领域的创新药物,从日本和欧美领先的制药和生物技术公司引进优秀产品,并获得商业开发的许可,为中国及亚洲国家的病患带来健康福音。苏爱康积极回应患者与健康专业人员的需求,为改善患者生活,实现肿瘤领域突出且未满足的医疗需求而努力。

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    2019-04-29 cenghis
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    2019-09-27 kalseyzl
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