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href="/info/41.html"> <i class="iconfont icon-next-01"></i> <span>下一篇</span> </a> </div> </div> <div id="xjyiinh" class="info-box-bd"> <div id="myicmwl" class="info-box"> <div id="rtdn3js" class="tit">貝海生物BH011 新藥項目新適應癥II期臨床獲批</div> <div id="xuuzon7" class="info-type"> <div id="co7rl3n" class="time">2022-04-18</div> <div id="r2kmbqp" class="source">來(lái)源：貝海生物</div> </div> </div> <div id="kxcgfuz" class="content-box"><strong><span style="color:#003399;">近日，珠海貝海生物技術(shù)有限公司（以下簡(jiǎn)稱(chēng)“貝海生物”）宣布，公司已收到國家藥品監督管理局核準簽發(fā)的《藥物臨床試驗批準通知書(shū)》，批準開(kāi)展一項BH011注射液通過(guò)膀胱灌注治療中、高危非肌層浸潤性膀胱癌的II期臨床研究，進(jìn)一步擴展潛在獲益人群。這是BH011項目繼2021年獲批進(jìn)入I期臨床后又一新適應癥上取得研發(fā)進(jìn)展。</span></strong><br /> <p> <br /> </p> <p style="text-align:center;"> <img src="/uploads/image/20230801/20230801093143_4508.png" alt="" /> </p> <p style="text-align:center;"> 截圖來(lái)源：CDE官網(wǎng) </p> <p> <br /> </p> <span style="color:#003399;"><strong>關(guān)于BH011項目</strong></span><br /> <br /> BH011注射液是由貝海生物自主開(kāi)發(fā)的全球首款可通過(guò)膀胱灌注給藥的多西他賽創(chuàng )新品種，目前國內外無(wú)同類(lèi)產(chǎn)品上市。BH011注射液擬用于非肌層浸潤性膀胱癌（Non-muscle-invasive Bladder Cancer，NMIBC）的膀胱灌注治療。BH011注射液能夠顯著(zhù)增強多西他賽在膀胱組織中的滲透能力，使膀胱癌細胞暴露在更高濃度的藥物下，提高了多西他賽對膀胱癌細胞的抗腫瘤活性。目前臨床上可用于膀胱灌注的治療藥物包括化療藥物和BCG為代表的免疫藥物，但在療效、安全性、可及性上仍存在重大未滿(mǎn)足的臨床需求。BH011臨床前研究結果表明，多西他賽可進(jìn)入膀胱固有層，提高了多西他賽對非肌層浸潤性膀胱癌的抗腫瘤活性，且對膀胱無(wú)任何刺激性，系統毒性較小。BH011注射液有望成為NMIBC患者的臨床一線(xiàn)用藥。<br /> <br /> BH011于2021年獲批臨床后，目前已在多家中心開(kāi)展用于BCG治療失敗后的極高危非肌層浸潤性膀胱癌的I期臨床試驗。此次在中、高危非肌層浸潤性膀胱癌患者中獲批開(kāi)展II期臨床試驗，不僅使得公司的創(chuàng )新藥在研管線(xiàn)進(jìn)一步得到深化，也拓展了貝海在膀胱癌治療領(lǐng)域的布局，期待早日惠及更多患者。<br /> <br /> <br /> <strong><span style="color:#003399;">關(guān)于NMIBC</span></strong><br /> <br /> 膀胱癌是起源于膀胱尿路上皮的惡性腫瘤，是泌尿系統最常見(jiàn)的惡性腫瘤之一。膀胱癌按腫瘤侵犯程度可分為NMIBC、肌層浸潤性膀胱癌和遠處轉移性膀胱癌。在初診膀胱癌患者中，約75%處于NMIBC疾病階段。2016-2020年的中國NMIBC市場(chǎng)復合年增長(cháng)率為11.0%，預計于2025年達到36億元，2030年將達到88億元。NMIBC膀胱癌復發(fā)率高，是目前診療花費最高的腫瘤之一。經(jīng)尿道膀胱腫瘤切除術(shù)和術(shù)后膀胱灌注治療（包括化療藥物和BCG）是目前NMIBC的標準治療方案。對于高危NMIBC患者，指南推薦BCG膀胱灌注，但仍有約50%的患者在5年內發(fā)生腫瘤復發(fā)。NMIBC 患者具有強烈的未被滿(mǎn)足的臨床需求：膀胱灌注藥物失效后，沒(méi)有良好的二線(xiàn)治療方案選擇，只能接受根治性膀胱全切切除術(shù)，生活質(zhì)量顯著(zhù)下降?，F有臨床使用藥物在療效、安全性、可及性上均存在重大未滿(mǎn)足的臨床需求。<br /> <br /> 因此，臨床急需一款新的療效顯著(zhù)且不良反應少的膀胱灌注治療藥物用于治療NMIBC。BH011有望降低該類(lèi)患者的復發(fā)風(fēng)險，提高患者生活質(zhì)量。<br /> <br /> <br /> <strong><span style="color:#003399;">關(guān)于貝海生物</span></strong><br /> <br /> 貝海生物是一家處于臨床階段的生物醫藥企業(yè)，致力于開(kāi)發(fā)以患者為中心臨床需求未滿(mǎn)足的腫瘤創(chuàng )新藥。公司擁有全球首創(chuàng )的新藥平臺技術(shù)，具備持續的創(chuàng )新能力，前瞻性的布局了10余個(gè)差異化的創(chuàng )新藥物研發(fā)管線(xiàn)，通過(guò)自主研發(fā)累計申請70余項發(fā)明專(zhuān)利申請，已獲得近20項中國、美國、歐盟等發(fā)明專(zhuān)利授權。<br /> <br /> 目前，貝海生物在中國、美國已獲得6個(gè)臨床試驗許可（IND），其中1項關(guān)鍵性臨床試驗已達到主要研究終點(diǎn)，其他多個(gè)項目已進(jìn)入臨床或臨床前研究階段。<br /> <br /> 貝海生物堅持以源頭創(chuàng )新為核心驅動(dòng)力，洞察并挖掘未被滿(mǎn)足的臨床需求，秉承“具有全球視野，聚焦臨床價(jià)值”的開(kāi)發(fā)策略，不斷開(kāi)發(fā)臨床急需、安全、有效的腫瘤藥物，為全球腫瘤患者提供更好的治療方案，致力于成為在腫瘤領(lǐng)域一流的生物醫藥企業(yè)。<br /></div> </div> </div> </div> </div> <div id="eqeujn3" class="footer"> <div id="k7ygqko" class="container"> <div id="fblvlaa" class="flex-box"> <div id="ipj8nmw" class="l"> <div id="ubgv28y" class="f-logo pc-box wow fadeInRight"> <a href="/"> <img src="/uploads/image/img/logo.svg" alt=""> </a> </div> <div id="3wqf8mg" class="f-menu"> <ul class=" wow fadeInRight" data-wow-delay="0s"> <li><a href="/list/2.html">關(guān)于貝海</a></li> <li><a href="/list/12.html">創(chuàng )新研發(fā)</a></li> <li><a href="/list/4.html">新聞中心</a></li> </ul> <ul class=" wow fadeInRight" data-wow-delay="0.1s"> <li><a href="/list/5.html">職業(yè)發(fā)展</a></li> <li><a href="/list/6.html">聯(lián)系我們</a></li> </ul> </div> <div id="hty39ss" 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