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搜尋結果Search Result

符合「C-STAT」新聞搜尋結果, 共 52 篇 ,以下為 1 - 24 篇 訂閱此列表,掌握最新動態
IAR於EE Awards Asia 2024連續第三年榮獲開發工具獎

全球嵌入式系統研發領域之軟體領導者IAR今日宣布其嵌入式開發工具IAR Embedded Workbench Functional Safety於「EE Awards Asia 2024 亞洲金選獎」連續第三年榮獲產品獎類別 (Product Award Category)「開發工具獎 ( Development Kits)」。此榮耀歸功於IAR致力支持開發人員透過針對關鍵安全應用所提供通過認證之靜態分析工具C-STAT來創建安全、可靠且合規的嵌入式應用;更重要的是,IAR在地服務團隊皆為經認證之功能安全專家,可為客戶提供即時而全面性的專業服務。 IAR Embedded Workbench Functional Safety將靜態分析無縫整合至CI-based工作流程,使開發人員和團隊在自動化和遵循功能安全標準時更具信心。該工具通過TÜV SÜD認證,藉由執行全面性的靜態分析協助開發人員發揮符合安全標準的關鍵作用,並能偵測包括程式碼漏洞及偏離MISRA C與CERT C等程式碼撰寫標準的各種潛在問題。該保護性偵測機制的關鍵重要性在於協助防範在開發周期後期昂貴且耗時的修正作業,進而能強化整體可信賴性並加速產品上市。 「EE Awards Asia 2024 亞洲金選獎」主要表彰產業領域內的優秀企業、產品以及對產業貢獻卓著之人物,並且是亞洲及台灣電子產業中廣受讚譽之設計解決方案指南。2024年邀集全球170家企業、超過400份報名角逐獎項。其中,IAR Embedded Workbench Functional Safety從台灣及亞太區廣大網路用戶群、及主辦單位ASPENCORE旗下全球編輯群與業界專家之評選脫穎而出,使該公司的開發工具連續第三年榮獲「開發工具獎」。 IAR亞太區副總裁Kiyo Uemura表示:「IAR很榮幸在EE Awards Asia 2024連續第三次榮獲開發工具獎,連續獲獎證明IAR的開發工具獲得客戶和工程族群的廣泛認可和支持。隨著嵌入式系統複雜性不斷提升,功能安全變得越來越重要。透過選擇預先認證的解決方案,客戶將可節省寶貴的時間和成本,使其能更專注於程式碼和功能本身。IAR Embedded Workbench Functional Safety提供可支援標準和所涵蓋規則的寶貴資訊,進一步協助開發人員確保應用程式的合規性和可信賴性,輔以IAR專業的在地支援團隊,我們已準備好協助客戶成功實現下一個關鍵安全應用。」  更多關於已認證IAR Embedded Workbench Functional Safety資訊,及其他IAR 針對開發功能安全相關應用之解決方案請參閱: https://www.iar.com/products/requirements/functional-safety/. 

文章來源 : insightpr 發表時間 : 瀏覽次數 : 3822 加入收藏 :
Complete Genomics announces mpox virus amplicon sequencing panel at AMP

VANCOUVER, BC, Nov. 21, 2024 /PRNewswire/ -- Complete Genomics, a San Jose, Calif.-based genomic sequencer manufacturer, today announced at the 2024 Association for Molecular Pathology (AMP) Annual Meeting & Expo the launch of its mpox (MPXV) virus amplicon sequencing panel, part of its sequencing product portfolio for pathogenic microorganisms. Complete Genomics is at AMP this week at Booth #1524. The recent surge in mpox cases is attributed to a novel strain of the virus MPXV, which exists in two clades: clade I and clade II. The global outbreak in 2022 was driven by clade II, while the newly identified Ib clade of mpox has been spreading across Africa in recent months. According to STAT, 115,000 mpox cases – clade I and clade II - have been reported in 123 countries in 2024. This week, the Centers for Disease Control and Prevention confirmed that a strain of mpox previously undetected in the U.S. was confirmed by the California Dept. Of Public Health in an individual who had recently traveled from Eastern Africa. State health officials in California reported no evidence of transmission to other people in the case. "The new strain of the mpox virus demonstrates why it is crucial to public health for researchers worldwide, including American researchers, to access affordable and high-quality sequencing products," said Rob Tarbox, VP of Product and Marketing at Complete Genomics. "These products are rapidly upgraded to enhance the identification and monitoring of new mpox virus strains." The new mpox virus amplicon sequencing panel, a targeted sequencing product based on ATOPlex multiplex PCR technology and developed with proprietary reagents, instruments and software. It covers the full-length genome of the virus, enabling rapid identification and traceability, with relative quantification of the virus. The MPXV analysis software supports virus identification, mutation detection, and strain typing, allowing for rapid and accurate analysis of sequencing data. The panel is compatible with Complete Genomics sequencing instruments DNBSEQ-G99, DNBSEQ-E25, and DNBSEQ-G400 and features automated library preparation and data analysis. In South America, Complete Genomics has also launched an end-to-end NGS solution for DENV virus that causes dengue fever, including sample extraction ATOPlex amplicon-based library preparation, DNBSEQ sequencing, and data analysis. About Complete Genomics Complete Genomics is a pioneering life sciences company that provides novel, end to end DNA sequencing solutions. It has been at the forefront of high throughput cost-effective sequencing technology development since its inception in 2005. Our products have powered over 9,400 publications across a wide array of applications. To learn more, visit www.completegenomics.com. * For Research Use Only. Not for use in diagnostic procedures.    

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 425 加入收藏 :
IAR與鴻軒科技共同推進汽車未來

全球嵌入式研發領域軟體與服務領導者IAR日前宣布,與鴻軒科技(SiliconAuto B. V.)合作。IAR將成為鴻軒科技之功能安全(FuSa)方案開發夥伴,透過IAR Embedded Workbench for Arm協助開發車用晶片,輔以C-STAT、C-RUN分析工具,以高整合度加速客戶產品上市,共同提升車用晶片安全功能,並推動未來汽車技術之發展。   鴻軒科技由鴻海科技集團與全球領導車廠Stellantis共同投資設立,專注設計適用於各類車用系統的晶片技術。鴻軒科技的三大產品線,包括微控制器(MCU)、SerDes 以及 SoC。這些技術推動了多樣ECU (electronic control unit),如BCM (body control module)、攝影機與顯示數據傳輸以及駕駛輔助系統等應用發展。   汽車產業中所運用之程式均須通過功能安全 (FuSa) 認證,並完成嚴格的檢查程序與測試階段,使用合適的工具是確保程式碼品質、加速開發進度及提升效率的關鍵因素。鴻軒科技在選擇車用晶片開發夥伴時,始終將功能安全視為核心需求,因此選擇 IAR 作為其功能安全 (FuSa) 解決方案的合作夥伴,共同推動高效能且高可靠性的開發流程。   鴻軒科技系統平台設計處處長林宏文表示:「我們的客戶群對於合作方的解決方案品質具有非常嚴格的要求,因此在專案最初期透過其推薦、已驗證的IAR方案讓我們深具信心。IAR 於FuSa的深厚經驗讓我們可快速地進行開發與驗證,維持開發版本一致性。更重要的是,IAR在地服務團隊為擁有認證之功能安全專家,能提供最即時與完備的專業服務,這對於高度需要技術支援之車用產業特別重要。」   鴻軒科技選用IAR Embedded Workbench for Arm進行驅動程式開發及驗證於IC的正常運行,相關合作也使鴻軒的MCU能充分發揮於BCM車身控制器的高度安全功能。IAR Embedded Workbench for Arm完備的開發工具鏈包含高度最佳化的編譯器以及先進除錯功能,如IAR提供的程式碼分析工具主動找出各種程式碼問題、並提升程式碼品質、及盡可能減少潛在的資安攻擊途徑,確保發掘與消弭各種防禦漏洞。   IAR 亞太區副總裁Kiyo Uemura表示:「IAR很高興能提供最佳的功能安全解決方案,協助鴻軒提供更可靠的車用晶片技術。全球的汽車產業蘊含極大的潛力,MCU的發展已成為汽車電子智慧創新的關鍵推動因素,IAR 將繼續不斷地與如鴻軒科技等優質生態夥伴合作,為安全嵌入式應用奠定基礎,提供從產品開發到大量生產的安全防護,並支援全球汽車產業創造今日的產品和實現未來的創新。」   IAR提供從設計到開發之整個流程具備完全整合且一致性的解決方案,協助簡化設計流程,節省設計時間與成本,使客戶專注於創新。IAR Embedded Workbench for Arm 不僅具高度整合性,同時也具備編碼一致性,不僅可使客戶的開發、驗證更有效率,更可協助客戶更快將產品上市,使其先掌握並滿足車用市場未來需求。   更多關於IAR Embedded Workbench for Arm之資訊請瀏覽www.iar.com/ewarm

文章來源 : insightpr 發表時間 : 瀏覽次數 : 4256 加入收藏 :
FSG (功能安全專家小組)的創始成員SGS、晶心科技及IAR共同探討 如何因應ISO 26262標準,加速RISC-V功能安全開發設計

FSG (功能安全專家小組)的創始成員SGS Taiwan、晶心科技(Andes Technology)及IAR今日於新竹舉辦技術研討會,邀集產業夥伴及領域專家針對RISC-V環境之功能安全應用,以及如何因應ISO 26262標準縮短認證流程、加速設計進行交流,研討會吸引廣泛參與,充分展現業界對於深入了解RISC-V開發環境的高度需求。 隨著RISC-V核心在SoC和商用微控制器的採用漸趨普遍,對於將在近期設計中選用RISC-V的企業而言,對於功能安全的要求也越來越高,如何整合高品質的軟硬體工具和開發解決方案以因應廣泛的測試和驗證,已成為取得RISC-V功能安全認證以加速產品開發的重要關鍵。 本次技術研討會針對在RISC-V背景下,如何採用更新功能安全標準和認證工作流程進行探討,同時說明如何選擇認證的合規軟體開發工具以因應測試挑戰,透過可擴展的軟體架構因應各種應用需求。會中,晶心科技分享了RISC-V方案產品、入門方式及客戶成功案例,SGS則針對ISO 26262的發展歷程及導入進行說明,而IAR則介紹支援RISC-V架構的預認證C-STAT靜態分析工具如何加速程式碼品質自動化,透過軟體品質和安全性的提升確保合規性,節省開發時間。 IAR亞太區副總裁Kiyo Uemura表示:「IAR致力於賦能開發者和推動整個嵌入式RISC-V產業發展。因應各界對於RISC-V 技術的持續採用,IAR很高興能與FSG成員攜手提升RISC-V產品功能安全,也承諾將透過專業的開發工具支持RISC-V生態系統和客戶,協助開發高品質嵌入式應用,推升RISC-V的持續發展。」 晶心科技資深技術經理王庭昭表示:「很高興與FSG成員合作,讓客戶在其產品認證過程中充分利用經認證的安全解決方案。晶心科技是第一家獲得 ISO 26262全面合規的RISC-V CPU IP公司,隨著通過認證之開發流程到位,我們已備妥完整的ISO 26262 功能安全系列產品路線圖以利產業供應鏈的發展。」 SGS技術經理暨功能安全專家張國樑表示:「我們很高興能與FSG小組成員及晶心科技透過此次技術研討會延伸功能安全標準應用與技術,同時分享最新的ISO 26262標準發展進程。SGS將持續提供協助RISC-V產品軟硬體設計與驗證,與FSG成員共同探索市場商機。」 FSG繼2024年4月成立後獲得業界廣泛支持,近日觸角更延伸至東南亞,透過舉辦嵌入式開發環境功能安全研討會為當地產業提供最新技術及服務諮詢。歡迎瀏覽FSG.tw網站,掌握最新功能安全技術發展及下載趨勢白皮書。也歡迎提出設計應用諮詢,由功能安全專家小組為您提供專業解方。 關於FSG FSG(功能安全專家小組)成立於2024年4月,由一群致力於提供一站式功能安全技術諮詢服務、並為提高嵌入式產業安全性之企業夥伴組成。FSG致力於提供與功能安全認證相關的技術、產品和開發資源,協助產業提升功能安全認證價值。

文章來源 : insightpr 發表時間 : 瀏覽次數 : 4792 加入收藏 :
信達生物IBI363 (PD-1/IL-2α-bias雙特異性抗體融合蛋白) 獲得美國FDA快速通道資格認定,治療黑色素瘤

美國舊金山和中國蘇州2024年9月4日 /美通社/ -- 信達生物製藥集團(香港聯交所股票代碼:01801),一家致力於研發、生產和銷售腫瘤、自身免疫、代謝、眼科等重大疾病領域創新藥物的生物製藥公司,宣佈其PD-1/IL-2α-bias雙特異性抗體融合蛋白IBI363獲得美國食品和藥物監督管理局(FDA)授予快速通道資格(fast track designation, FTD),擬定適應症為既往接受過至少一線含PD-1/L1檢查點抑制劑系統性治療後進展的局部晚期或轉移性黑色素瘤(脈絡膜黑色素瘤除外)。目前,信達生物正在中國、美國、澳大利亞同時開展1/2期臨床研究探索IBI363在各種晚期惡性腫瘤的有效性和安全性。 2024年6月14日的ESMO全體會議上,IBI363報道了在既往接受過免疫治療的黑色素瘤受試者中觀察到令人欣喜的療效信號:37例既往接受過免疫治療的黑色素瘤患者接受了1mg/kg IBI363治療並至少接受了一次基線後腫瘤評估,11例患者獲得了客觀緩解,包括1例CR和10例PR,ORR和DCR分別為29.7%和73.0%。(鏈接) 信達生物製藥集團高級副總裁周輝博士表示:「黑色素瘤是歐美國家最常見的致死性皮膚癌症。在中國,黑色素瘤雖屬於少見惡性腫瘤,但病死率高,發病率也在逐年增加。儘管免疫檢查點抑制劑在黑色素瘤治療上已取得了成功,但全球目前尚無針對免疫治療失敗黑色素瘤的藥物獲批,傳統的化療±抗血管治療免疫治療失敗黑色素瘤的ORR僅3.8%~6.8%,中位PFS不足3個月,獲益非常有限[1]-[2]。因此,對於既往免疫治療失敗的患者,存在亟待滿足的臨床需求。作為全球首創(First-in-class)PD-1/IL-2α-bias雙特異性抗體融合蛋白,目前IBI363單藥在既往接受過免疫治療的黑色素瘤受試者中顯示出鼓舞人心的療效和良好的安全性。我們將繼續探索IBI363在黑色素瘤中的療效和安全性數據,為免疫耐藥的黑色素瘤患者提供更有效的臨床治療手段。」 快速通道認定(Fast Track Designation, FTD)是有FDA設立的藥物臨床開發快速審評過程,旨在促進用於治療嚴重疾病和解決未滿足臨床需求的新藥研發。根據規定,獲得FTD資格的候選藥物,將在後續的藥物研發與審評過程中,獲得更多與FDA溝通交流的機會,有助於加快藥物的後續研發和獲批上市。 關於IBI363(PD-1/IL-2α-bias雙特異性融合蛋白) IBI363是由信達生物自主研發的全球首創PD-1/IL-2雙特異性融合蛋白,同時具有阻斷PD-1/PD-L1通路和激活IL-2通路兩項功能。IBI363的IL-2臂經過了設計改造,保留了其對IL-2 Rα的親和力,但削弱了對IL-2Rβ和IL-2Rγ的結合能力,以此降低毒性;而PD-1結合臂可以同時實現對PD-1的阻斷和IL-2的選擇性遞送。由於新激活的腫瘤特異性T細胞同時表達PD-1和IL-2α,這一差異性策略可以更精確和有效地實現對該T細胞亞群的靶向和激活。IBI363不僅在多種荷瘤藥理學模型中展現出了良好抗腫瘤活性,在PD-1耐藥和轉移模型中也表現出了突出的抑瘤效力。從臨床迫切需求出發,信達生物正在中國、美國、澳大利亞開展臨床研究探索IBI363在針對各種晚期惡性腫瘤的有效性和安全性。 關於黑色素瘤 黑色素瘤是一種從黑色素細胞發展而來的惡性腫瘤,是美國第五大最常見的癌症病因[3]。雖然黑色素瘤只佔所有類型皮膚癌的3%,但它的死亡率是所有類型中最高的,而且最容易發生轉移。在中國,黑色素瘤的發生率和死亡率也在逐年增加。按發病部位分類,黑色素瘤主要分為皮膚黑色素瘤、肢端黑色素瘤和粘膜黑色素瘤等。中國黑色素瘤與歐美白種人差異較大,兩者在發病機制、生物學行為、組織學形態、治療方法以及預後等方面差異較大[4]。對於晚期皮膚和肢端黑色素瘤,如攜帶 BRAF V600 突變,則首選分子靶向藥物BRAF抑制劑聯合MEK抑制劑,無BRAF V600突變的患者一線治療可考慮化療與抗血管生成藥物聯合治療,免疫治療尚未在國內獲批晚期黑色素瘤一線治療的適應症。二線主要考慮與已接受一線治療不同的藥物治療,對於一線未使用過PD-1單抗的受試者,二線治療可選擇PD-1單抗。對於晚期粘膜黑色素瘤,一線治療可考慮化療或PD-1單抗聯合抗血管生成藥物,如攜帶BRAF V600突變,可選擇BRAF抑制劑±MEK 抑制劑,後線治療選擇十分有限[5]。 關於信達生物 「始於信,達於行」,開發出老百姓用得起的高質量生物藥,是信達生物的使命和目標。信達生物成立於2011年,致力於研發、生產和銷售腫瘤、自身免疫、代謝、眼科等重大疾病領域的創新藥物,讓我們的工作惠及更多的生命。公司已有11個產品獲得批准上市,它們分別是信迪利單抗注射液(達伯舒®),貝伐珠單抗注射液(達攸同®),阿達木單抗注射液(蘇立信®),利妥昔單抗注射液(達伯華®),佩米替尼片(達伯坦®),奧雷巴替尼片(耐立克®), 雷莫西尤單抗注射液(希冉擇®),塞普替尼膠囊(睿妥®),伊基奧侖賽注射液(福可蘇®),托萊西單抗注射液(信必樂®)和氟澤雷塞片(達伯特®)。目前,同時還有3個品種在NMPA審評中,4個新藥分子進入III期或關鍵性臨床研究,另外還有18個新藥品種已進入臨床研究。 公司已與禮來、羅氏、賽諾菲、Adimab、Incyte和MD Anderson 癌症中心等國際合作方達成30多項戰略合作。信達生物在不斷自研創新藥物、謀求自身發展的同時,秉承經濟建設以人民為中心的發展思想。多年來,始終心懷科學善念,堅守「以患者為中心」,心繫患者並關注患者家庭,積極履行社會責任。公司陸續發起、參與了多項藥品公益援助項目,讓越來越多的患者能夠得益於生命科學的進步,買得到、用得起高質量的生物藥。至2023年10月,信達生物患者援助項目已惠及17余萬普通患者,藥物捐贈總價值34億元人民幣。信達生物希望和大家一起努力,提高中國生物製藥產業的發展水平,以滿足百姓用藥可及性和人民對生命健康美好願望的追求。 詳情請訪問公司網站:www.innoventbio.com 或公司領英賬號www.linkedin.com/company/innovent-biologics/。 1.信達生物不推薦未獲批的藥品/適應症的使用 2.雷莫西尤單抗注射液(希冉擇®)和塞普替尼膠囊(睿妥®)由禮來公司研發 前瞻性聲明 本新聞稿所發佈的信息中可能會包含某些前瞻性表述。這些表述本質上具有相當風險和不確定性。在使用「預期」、「相信」、「預測」、「期望」、「打算」及其他類似詞語進行表述時,凡與本公司有關的,目的均是要指明其屬前瞻性表述。本公司並無義務不斷地更新這些預測性陳述。 這些前瞻性表述乃基於本公司管理層在做出表述時對未來事務的現有看法、假設、期望、估計、預測和理解。這些表述並非對未來發展的保證,會受到風險、不確性及其他因素的影響,有些乃超出本公司的控制範圍,難以預計。因此,受我們的業務、競爭環境、政治、經濟、法律和社會情況的未來變化及發展的影響,實際結果可能會與前瞻性表述所含資料有較大差別。 本公司、本公司董事及僱員代理概不承擔 (a) 更正或更新本網站所載前瞻性表述的任何義務;及 (b) 若因任何前瞻性表述不能實現或變成不正確而引致的任何責任。   參考文獻 [1] Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949. [2] European Journal of Cancer 162 (2022) 22e33; [3] National Cancer Institute Melanoma of the Skin-Cancer Stat Facts: https://seer.cancer.gov/statfacts/html/melan.html.  [4] 黑色素瘤診療規範(2022 年版) . [5] 中國臨床腫瘤學會(CSCO)黑色素瘤診療指南(2022年版) .    

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Innovent Receives Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α Bispecific Antibody Fusion Protein) as Monotherapy for Advanced Melanoma

SAN FRANCISCO and SUZHOU, China, Sept. 4, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein (R&D code: IBI363) for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor. Phase 1/2 clinical trials are currently underway in China, the U.S., and Australia to assess IBI363's efficacy and safety in various advanced malignant tumors. At the ESMO Plenary meeting on June 14, 2024, Innovent presented promising efficacy signals in melanoma patients who had previously undergone immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively. (Link) Dr. Hui Zhou, Senior Vice President of Innovent, said, "Melanoma is the most common fatal skin cancer in Europe and the United States. In China, while melanoma is a rare malignant tumor, it has a high fatality rate, and its incidence is steadily increasing each year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma." Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug. About Melanoma Melanoma is a malignant tumor that develops from melanocytes and is the fifth most common cause of cancer in the United States[3]. Although melanoma represents only 3% of all skin cancer cases, it has the highest mortality rate and is the most prone to metastasize. In China, both the incidence and mortality rates of melanoma have been steadily rising over the years. According to the classification of the disease site, melanoma is mainly divided into skin melanoma, acral and mucosal melanoma. Chinese melanoma differs greatly from European and American Caucasian melanoma in pathogenesis, biological behavior, histological morphology, treatment and prognosis[4]. For advanced cutaneous and acral melanomas, for those carrying BRAF V600 mutation, BRAF inhibitor combined with MEK inhibitor is the preferred molecular targeted therapy. For patients without a BRAF V600 mutation, comination of chemotherapy and anti-angiogenic drugs may be considered as the first-line treatment. Immunotherapy has not been approved as the first-line treatment indication for advanced melanoma in China. For second-line treatment, therapies not used in the first-line are recommended. If a PD-1 monoclonal antibody was not administered initially, it can be selected for the second-line. In advanced mucosal melanoma, chemotherapy or a combination of PD-1 monoclonal antibody and anti-angiogenic drugs may be considered as first-line options. For patients with BRAF V600 mutation, a BRAF inhibitor ±MEK inhibitor can be chosen. Currently, posterior treatment options for melanoma are very limited[5]. About IBI363 (PD-1/IL-2α) IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 functions by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, enabling more precise and efficient targeting and activation of tumor specific T cells. IBI363 has demonstrated notable anti-tumor activity across various tumor-bearing pharmacological models and showed significant antitumor efficacy in both PD-1 resistant and metastatic models. Additionally, IBI363 exhibited a favorable safety profile in preclinical models. Clinical studies of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References: [1] Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949. [2] European Journal of Cancer 162 (2022) 22e33; [3] National Cancer Institute Melanoma of the Skin-Cancer Stat Facts: https://seer.cancer.gov/statfacts/html/melan.html.  [4] Melanoma Diagnosis and Treatment (2022). [5] Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines (2022).  

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