最新消息:

中國抗體的旗艦產品舒西利單抗SM03的作用機理在美國免疫領域權威期刊the Journal of Immunology上成功發表

專欄 admin 0評論

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 1364

Warning: preg_match_all(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 684

Warning: Invalid argument supplied for foreach() in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 691

Warning: preg_match_all(): Compilation failed: invalid range in character class at offset 4 in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 684

Warning: Invalid argument supplied for foreach() in C:\wwwroot\niuniuwang.cn\wp-content\plugins\wp-chinese-conversion\simple_html_dom.php on line 691
2022年6月21日 15時40分

中國抗體的旗艦產品舒西利單抗SM03的作用機理在美國免疫領域權威期刊the Journal of Immunology上成功發表

香港, 2022年6月21日 – (亞太商訊) – 中國抗體製藥有限公司(“中國抗體”或“公司”,連同其附屬公司,統稱“集團”;股份代號:3681.HK),一家專註於研究、開發、製造及商業化免疫疾病創新療法的香港生物製藥上市公司,主要研製以單克隆抗體為基礎的生物葯,欣然宣布,其旗艦產品SM03舒西利單抗(Suciralimab)的作用機理已於2022年6月10日在美國免疫領域權威期刊the Journal of Immunology上成功發表(論文鏈接:https://www.jimmunol.org/content/early/2022/06/10/jimmunol.2100820 )。

圖:舒西利單抗SM03(Suciraslimab)作用機理

The Journal of Immunology(the JI),於1916年創刊,由美國免疫學家協會管理和出版,是世界上免疫學領域的頂級同行評鑒刊物,5年影響因子為6.029(2020年期刊引文報告),發布免疫學領域在基礎研究和臨床研究上的和免疫相關的最新發現,同時發表免疫學領域的最新研究論文,包括細胞免疫學、免疫化學和分子免疫學、免疫遺傳學和免疫調節、免疫病理學和臨床免疫學、免疫藥理學、微生物免疫學、腫瘤和移植。

公司旗艦產品舒西利單抗SM03(Suciraslimab)為全球首項用以治療類風濕性關節炎的潛在抗CD22單抗。該產品已於2021年底在中國完成III期臨床試驗受試者入組,合計招募530例受試者。該試驗為由中國醫學科學院北京協和醫院牽頭的多中心臨床研究,臨床中心包括南京大學醫學院附屬鼓樓醫院、哈爾濱醫科大學附屬第二醫院、山西醫科大學第一醫院等44家醫院。公司預計今年6月底進行鎖庫,8月初讀出III期臨床試驗數據結果,並將於2023年申請新葯上市(BLA)。此外,舒西利單抗(Suciraslimab)的研發也獲得了863計劃、“十二五”及“十三五”重大新葯創製專項支持,且享受國家藥品評審中心(CDE)“優先審評審批”綠色通道。此前,由北京協和醫院領導的II期臨床試驗已驗證舒西利單抗(Suciraslimab)對類風濕關節炎治療有較好的療效性及較高的安全性。

公司旗艦產品舒西利單抗(Suciraslimab)是全球首項用於治療類風濕性關節炎的潛在抗CD22單抗。該產品與目前市場上現有標準療法的核心競爭優勢在於其新穎獨特的作用機理,保證了舒西利單抗在與其他產品療效相當的情況下,在安全性方面有顯着的優勢,而安全性正是長期用藥的自身免疫疾病患者需要關注的核心問題。

在人體免疫系統正常運行的前提下,當外來抗原入侵時,B細胞受體通路會被激活,向B細胞傳遞抗原刺激信號,引發一系列B細胞免疫反應。而在面對自身抗原時,正常的機體會招募免疫抑制分子如SHP-1,通過阻止或是減弱B細胞受體通路向B細胞傳遞抗原刺激信號來抑制B細胞相關免疫反應。我們認為,通過轉變CD22的結合方式,即CD22從順式結合轉變為反式結合可以達到招募這類免疫抑制分子,如SHP-1,進而達到抑制相關免疫反應的作用。

由於年齡或是遺傳傾向等原因,RA等自身免疫疾病患者在面對自身抗原時,RA患者的CD22不能從順式結合方式轉變為反式結合,進而不能夠招募例如SHP-1的免疫抑制分子來抑制或是減弱B細胞受體向B細胞內傳遞抗原刺激信號,B細胞接受到抗原刺激信號後,就會產生一系列免疫反應,如分泌大量抗體來攻擊自身抗原。而我們的旗艦產品舒西利單抗(Suciraslimab)可以幫助CD22由順式結合方式轉變為反式結合,形成穩定的CD22反式結合結構,進而恢復B細胞對自身抗原的容忍度,抑制B細胞發生一系列相關免疫反應攻擊自身機體。

通過歷史數據與目前市場現有其他產品相比,舒西利單抗(Suciraslimab)在療效相當的情況下,在安全性方面,相對其他產品有顯着的優勢。現有RA療法從甲氨蝶呤(MTX)等傳統合成改善病情抗風濕葯(csDMARDs),到靶向腫瘤壞死因子(TNF)、白介素(IL)-6受體等靶點的生物製劑DMARDs(bDMARDs),以及靶向合成DMARDs(tsDMARDs),例如Janus激酶(JAK)抑製劑等小分子藥物,這些新型藥物的引入,對RA患者的病情緩解都起到了重要的作用。但是目前現有RA療法的大部分作用機理都會導致B細胞的耗竭或是衰亡,對人體自身免疫系統都會產生一系列的副作用,這對需要長期用藥的自免疾病患者來說存有長期隱患,免疫系統的衰弱自然而然的會引發其他衰竭性疾病的發生。但是舒西利單抗的作用機理卻與目前市場的現有療法截然不同,我們只是通過改變CD22的結合方式,招募相關抑制分子,進而抑制B細胞相關免疫反應,舒西利單抗只是通過調節B細胞的功能來抑制自身免疫反應,並未損傷到B細胞,不影響B細胞在免疫系統中發揮正常作用。因此,舒西利單抗在相對於目前市場上已有的其他產品,在安全性方面有顯着的優勢。

自身免疫疾病用藥市場被譽為繼腫瘤之後的下一個金礦。修美樂作為全球“藥王”,雄踞全球藥物榜首長達8年,2020年198.32億美元的銷售額令其他藥品“俯首稱臣”。放眼全球,製藥巨頭十分關注風濕免疫領域藥物的研發,最突出的包括輝瑞、諾華、強生和艾伯維,管線中均有十餘個在研或上市的產品。全球自身免疫疾病藥物市場2018年的市場規模為1,137億美元,且預計到2023年將達到1,523億美元,複合年增長率為6.0%,中國自身免疫疾病藥物的市場規模預計將從2018年的134億元人民幣增長到2030年的377億元人民幣,複合年增長率為23%。受全球創新浪潮的衝擊,我國風濕免疫領域的研發熱情同樣高漲,恆瑞醫藥作為國內創新葯龍頭,在風濕免疫領域也採取了早布局、優靶點和廣適應症等策略,希望能夠充分享受國內自身免疫疾病市場快速發展的紅利。可見中國抗體致力成為免疫性疾病及其他衰竭性疾病創新療法的全球領導者的使命與願景是迎合整個醫藥行業的發展趨勢的,在可以預見的未來,相信中國抗體可以造福越來越多受自身免疫疾病困擾的患者,成為全球領先的以自身免疫疾病創新療法為主的生物製藥公司。

除旗艦產品舒西利單抗外,公司核心產品SN1011的適應症範圍不斷擴大,新葯研究申請不斷獲得海內外監管機構的批准,也預計在今年快速啟動天皰瘡(PV)、多發性硬化症(MS)、系統性紅斑狼瘡(SLE)、視神經脊髓炎(NMOSD)的二期臨床試驗,主要產品SM17也在今年6月份在美國剛剛完成臨床I期試驗首例健康受試者給葯,通過靶向Th2細胞相關炎性上游細胞因子通路的療法,能夠在較前端控制免疫級聯反應引發的哮喘等炎性氣道疾病,希望能夠為廣大未被滿足治療需求的嚴重不受控制的哮喘疾病患者帶來福音。

關於中國抗體製藥有限公司
中國抗體製藥有限公司專註於研究、開發、製造及商業化免疫性疾病療法。公司注重創新研發,其旗艦產品SM03為全球首項用以治療類風濕關節炎的潛在抗CD22單抗,已在中國進入類風濕關節炎三期臨床試驗,並被列為國家十三五重大新葯創製專項重大項目。此外還有多個同類靶點首創(First-in-target)及同類首創(First-in-class)在研藥物,部分已處於臨床階段,適應症範圍覆蓋類風濕性關節炎、系統性紅斑狼瘡、尋常型天皰瘡、非霍奇金氏淋巴瘤、哮喘等具有重大未滿足臨床需求的疾病。


News URL: https://www.acnnewswire.com/press-release/simplifiedchinese/75964/

轉載請註明:牛牛網 » 中國抗體的旗艦產品舒西利單抗SM03的作用機理在美國免疫領域權威期刊the Journal of Immunology上成功發表

與本文相關的文章


Warning: Use of undefined constant PRC - assumed 'PRC' (this will throw an Error in a future version of PHP) in C:\wwwroot\niuniuwang.cn\wp-content\themes\d8\comments.php on line 17

您必須 登錄 才能發表評論!