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    在創新藥方面,恒瑞已形成上市一批、臨床一批、開發一批的良性循環,在靶向治療、免疫療法、超長效胰島素等領域的新藥創制已經具備國際領先性。

    艾瑞昔布

    艾瑞昔布是恒瑞醫藥歷時14年自主研發的治療骨關節炎的1.1類創新藥,于2011年6月獲批上市,是一種針對特定靶點的COX-2選擇性抑制劑類抗炎鎮痛藥物,具有療效好、安全性高、副作用低等顯著特征。

    據統計,我國男性骨關節炎的發病率為58%,女性更上升至65%—67%,國內骨關節炎患者大約超過5000萬人,艾瑞昔布的上市為此類患者帶來良好療效,并有效打破了同類進口產品壟斷,降低了患者負擔。

    艾瑞昔布研究被列入國家“十一五”和“十二五”重大新藥創制項目、國家“863”重點技術項目,其化合物專利獲第15屆中國專利金獎,該產品2015年進入江蘇省醫保目錄,2017年進入國家醫保目錄。

    甲磺酸阿帕替尼

    甲磺酸阿帕替尼片是恒瑞醫藥歷時10年研發的具有自主知識產權的國家1.1類創新藥,于2014年10月獲批上市,2017年通過談判被納入國家醫保目錄。

    該藥是在晚期胃癌被證實安全有效的小分子抗血管生成靶向藥物,也是胃癌靶向藥物中的口服制劑。

    2015年6月,阿帕替尼的臨床研究被美國臨床腫瘤學會(ASCO)選作大會報告,并入選該年會優秀研究。2015年7月,阿帕替尼治療晚期胃癌Ⅱ期、Ⅲ期研究報告均刊登在國際專業學術期刊——美國《臨床腫瘤學雜志》(JCO)上。

    在2017年ASCO大會上,又有多達 22 項與阿帕替尼相關的基礎和臨床研究入選會議收錄的研究摘要,充分說明該產品獲得國際同行的認可。

    2018年8月,阿帕替尼聯合依托泊苷治療耐藥性卵巢上皮癌Ⅱ期臨床研究在《Lancet Oncology》(柳葉刀?腫瘤)上發表。這也是自國際醫學界腫瘤學雜志《Lancet Oncology》創刊以來,由中國大陸婦科腫瘤醫生所主導的臨床研究成果在該雜志發表。

    硫培非格司亭注射液

    該藥技術開發研究及藥物Ⅱ期和Ⅲ期臨床研究均被列入國家“十一五”、“十二五”重大新藥創制專項。 硫培非格司亭注射液

    硫培非格司亭注射液是恒瑞醫藥歷時十年自主研發的生物創新藥,是獲世界衛生組織(WHO)化學命名的G-CSF(粒細胞集落刺激因子)產品,中文通用名為“硫培非格司亭”。該產品采用創新聚乙二醇修飾蛋白技術,結構更穩定,ADA(抗藥抗體)更少, 減少免疫原性,安全可靠。其創新結構獲得國際多項專利,并獲得國家十二五“重大新藥創制”科技專項支持。

    G-CSF包括短效和長效兩種類型,短效G-CSF在每個化療周期內需要每日給藥1-2次,連續給藥5-14天,硫培非格司亭屬于長效G-CSF,每個化療周期僅需使用1次,能提高患者依從性,為預防中性粒細胞減少癥提供了新的治療選擇。硫培非格司亭的上市標志著恒瑞醫藥在生物醫藥創新領域取得實質性突破,將給患者帶來福音。

    馬來酸吡咯替尼片

    馬來酸吡咯替尼片是恒瑞醫藥自主研發的基于Ⅱ期臨床研究成果獲得國家藥監局優先審評有條件批準上市的創新藥。

    根據《2015中國癌癥統計數據》,乳腺癌已經成為我國女性發病率最高的惡性腫瘤,約占所有女性癌癥總發病率的16.5%。馬來酸吡咯替尼片為HER2陽性乳腺癌復發或轉移性乳腺癌患者提供了新的治療手段。

    2017年5月,《JCO》雜志全文發表了吡咯替尼的Ⅰ期研究結果,中國自主研發抗腫瘤藥物僅憑Ⅰ期研究就登上全球知名期刊。

    2017年5月,腫瘤領域專業期刊《Lancet Oncology》雜志也對吡咯替尼的1b期研究發表點評,對該新藥出色療效和較好的安全性做出了高度評價。

    2017年12月,吡咯替尼Ⅱ期臨床研究結果在美國圣安東尼奧乳腺癌大會上報道,并被列入2017年乳腺癌重大事件年度回顧。

    馬來酸吡咯替尼片是國家十二五“重大新藥創制”科技專項重點支持的項目之一。

    目前,吡咯替尼正在美國開展臨床研究。

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