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id="newstit">細(xì)胞治療產(chǎn)業(yè)發(fā)展?jié)摿Υ?/h1> <h4 class="sub"></h4> <div id="i0eggeegg" class="author cf">本報(bào)記者吳月輝</div> <div id="i0eggeegg" class="channel cf"> <div id="i0eggeegg" class="col-1-1 fl"> 2023年02月27日08:24 | 來(lái)源：<a target="_blank">人民網(wǎng)－人民日?qǐng)?bào)</a> </div> <div id="i0eggeegg" class="col-1-2 fr"> <span id="i0eggeegg" class="rm_type"><img src="/img/2020wbc/imgs/icon_type.png" alt=""><i>小字號(hào)</i></span> </div> </div> <div id="i0eggeegg" class="rm_txt_con cf"> <div id="i0eggeegg" class="bza"><span></span><p></p></div> <div id="i0eggeegg" class="box_pic"></div> <p style="text-align: center;"><img src="/mediafile/pic/20230227/73/5141779624147944137.jpg" alt="" /></p> <p style="text-indent: 2em; text-align: center;"><span style="font-size: 11pt;">天津細(xì)胞生態(tài)海河實(shí)驗(yàn)室科研人員在做染色體分析實(shí)驗(yàn)。何美瞳攝</span></p> <p style="text-align: center;"><img src="/mediafile/pic/20230227/0/50014809771655680.jpg" alt="" /></p> <p style="text-indent: 2em; text-align: center;"><span style="font-size: 11pt;">天津細(xì)胞生態(tài)海河實(shí)驗(yàn)室科研人員在觀察提取細(xì)胞遺傳物質(zhì)。何美瞳攝</span></p> <p style="text-indent: 2em;">和往常一樣，早上8點(diǎn)，天津細(xì)胞生態(tài)海河實(shí)驗(yàn)室研究員張英馳來(lái)到實(shí)驗(yàn)室，換好潔凈服，打開(kāi)生物安全柜的紫外燈，將培養(yǎng)基放在水浴鍋中。半小時(shí)后，他開(kāi)始處理細(xì)胞。顯微鏡下，細(xì)胞均勻分布，生長(zhǎng)狀態(tài)良好。消化傳代后的細(xì)胞將用于為T(mén)細(xì)胞提供精準(zhǔn)殺傷腫瘤細(xì)胞的武器，進(jìn)而走向臨床，最終成為第三代藥物——細(xì)胞治療藥物。</p> <p style="text-indent: 2em;">作為一種新興的治療方式，細(xì)胞治療在眾多疾病特別是癌癥、遺傳疾病、傳染病的治療中展現(xiàn)出良好的效果。近年來(lái)，在技術(shù)、政策、市場(chǎng)等驅(qū)動(dòng)下，我國(guó)細(xì)胞治療產(chǎn)業(yè)呈現(xiàn)出蓬勃發(fā)展的態(tài)勢(shì)，有望成為生物醫(yī)藥領(lǐng)域極具潛力的新賽道。</p> <p style="text-indent: 2em;"><strong>細(xì)胞療法，為疾病治療提供新選擇</strong></p> <p style="text-indent: 2em;">細(xì)胞治療是指采用生物工程的方法獲取具有特定功能的細(xì)胞，并通過(guò)體外擴(kuò)增、特殊培養(yǎng)等處理后，使這些細(xì)胞具有增強(qiáng)免疫、殺死病原體和腫瘤細(xì)胞等功能，從而達(dá)到治療某種疾病的目的。目前主要的細(xì)胞治療方式為免疫細(xì)胞治療和干細(xì)胞治療。</p> <p style="text-indent: 2em;">“免疫細(xì)胞治療，一般是指在體外對(duì)某些類型的免疫細(xì)胞如T細(xì)胞、NK細(xì)胞等進(jìn)行針對(duì)性處理后再回輸人體內(nèi)，使其表現(xiàn)出殺傷腫瘤細(xì)胞、清除病毒等功能。”張英馳說(shuō)，干細(xì)胞療法，則是把健康的干細(xì)胞移植到患者體內(nèi)，從而修復(fù)病變細(xì)胞或再建正常的細(xì)胞組織。在臨床上較常使用的干細(xì)胞種類主要是間充質(zhì)干細(xì)胞、造血干細(xì)胞、神經(jīng)干細(xì)胞等。</p> <p style="text-indent: 2em;">干細(xì)胞憑借其多向分化、免疫調(diào)節(jié)以及分泌細(xì)胞因子等功能，成為細(xì)胞治療研究的核心領(lǐng)域之一。近年來(lái)，基因工程技術(shù)的發(fā)展提升了細(xì)胞治療的靶向性，也推動(dòng)了細(xì)胞治療與基因治療相結(jié)合發(fā)展，出現(xiàn)了離體基因治療和載體基因治療。</p> <p style="text-indent: 2em;">張英馳舉例說(shuō)：“一些與造血系統(tǒng)相關(guān)的疾病，一般主要就是由于造血干細(xì)胞發(fā)生異常，里面的一些基因發(fā)生了突變。這時(shí)，我們就可以把患者的造血干細(xì)胞取出來(lái)，用基因編輯技術(shù)把突變的基因修復(fù)到正常的狀態(tài)，然后再把它移植回去。這就是離體基因治療?！?/p> <p style="text-indent: 2em;">細(xì)胞療法的出現(xiàn)，為一些傳統(tǒng)療法無(wú)效、難治的疾病治療提供了新的選擇。比如，由于個(gè)體差異，難以控制每例患者使用傳統(tǒng)藥物的最佳劑量。但在細(xì)胞治療中，可應(yīng)用合成生物學(xué)設(shè)計(jì)基因開(kāi)關(guān)，控制藥物的合成或釋放。同時(shí)，還可以根據(jù)患者的病情發(fā)展?fàn)顟B(tài)進(jìn)行動(dòng)態(tài)調(diào)整及預(yù)后監(jiān)測(cè)，以獲得長(zhǎng)期療效。</p> <p style="text-indent: 2em;"><strong>競(jìng)相布局，產(chǎn)業(yè)發(fā)展正進(jìn)入快車(chē)道</strong></p> <p style="text-indent: 2em;">在合源生物科技（天津）有限公司的生產(chǎn)車(chē)間里，一款CAR—T細(xì)胞治療產(chǎn)品正在生產(chǎn)制作當(dāng)中。</p> <p style="text-indent: 2em;">“細(xì)胞治療產(chǎn)品和傳統(tǒng)化學(xué)藥物有很大不同。免疫細(xì)胞從血液中分離出來(lái)之后，它的活性受到患者年齡、用藥史等因素的影響，從細(xì)胞采集、培養(yǎng)、基因修飾到再回輸患者體內(nèi)，進(jìn)行臨床治療的一系列措施都是個(gè)體化的。所以，一個(gè)患者對(duì)應(yīng)一個(gè)批次產(chǎn)品，也就是需要個(gè)性化定制?！焙显瓷锛夹g(shù)人員楊森說(shuō)，整個(gè)過(guò)程中對(duì)安全性要求非常高，耗材都是一次性的。</p> <p style="text-indent: 2em;">與傳統(tǒng)化學(xué)藥物相比，細(xì)胞治療產(chǎn)品具有技術(shù)迭代快、創(chuàng)新潛力大、臨床依賴度高、產(chǎn)品可個(gè)性化定制等特點(diǎn)，不少國(guó)家競(jìng)相布局。</p> <p style="text-indent: 2em;">當(dāng)前，全球細(xì)胞治療產(chǎn)業(yè)發(fā)展正進(jìn)入快車(chē)道。據(jù)統(tǒng)計(jì)，到2022年初，全球經(jīng)批準(zhǔn)的細(xì)胞治療產(chǎn)品共33款，包括12種免疫細(xì)胞產(chǎn)品和21種干細(xì)胞產(chǎn)品。</p> <p style="text-indent: 2em;">我國(guó)細(xì)胞治療發(fā)展時(shí)間較短，但勁頭十足。近年來(lái)，北京、上海、天津、深圳等地都在大力發(fā)展細(xì)胞治療產(chǎn)業(yè)。上海推出《上海市促進(jìn)細(xì)胞治療科技創(chuàng)新與產(chǎn)業(yè)發(fā)展行動(dòng)方案（2022—2024年）》，提出力爭(zhēng)到2024年上海細(xì)胞治療產(chǎn)業(yè)規(guī)模達(dá)到100億元。去年，深圳接連發(fā)布扶持生物醫(yī)藥產(chǎn)業(yè)發(fā)展的文件，將重點(diǎn)支持包括細(xì)胞治療藥物在內(nèi)的產(chǎn)業(yè)集群高質(zhì)量發(fā)展。</p> <p style="text-indent: 2em;">在天津，濱海高新區(qū)以細(xì)胞產(chǎn)業(yè)為突破口推進(jìn)京津冀特色細(xì)胞谷高質(zhì)量建設(shè)，圍繞細(xì)胞生態(tài)海河實(shí)驗(yàn)室為創(chuàng)新動(dòng)力核形成了“一核一帶一圈”產(chǎn)業(yè)發(fā)展空間布局體系，目前已集聚40余家細(xì)胞領(lǐng)域相關(guān)企業(yè)。</p> <p style="text-indent: 2em;">“我們大力推動(dòng)大院大所與高成長(zhǎng)型企業(yè)進(jìn)行深入合作?！碧旖?yàn)I海高新區(qū)生物醫(yī)藥局副局長(zhǎng)鄭純林說(shuō)，“比如合源生物主要做免疫細(xì)胞療法，如果從零起步，需要漫長(zhǎng)的研發(fā)周期。通過(guò)與中國(guó)醫(yī)學(xué)科學(xué)院血液學(xué)研究所合作，既能幫助企業(yè)快速突破關(guān)鍵技術(shù)門(mén)檻，也能助力研究所的前沿技術(shù)實(shí)現(xiàn)科技成果轉(zhuǎn)化?！?/p> <p style="text-indent: 2em;">據(jù)專家介紹，在細(xì)胞治療技術(shù)的主要領(lǐng)域——免疫細(xì)胞治療領(lǐng)域，我國(guó)已成為世界上開(kāi)展CAR—T細(xì)胞治療臨床研究數(shù)量最多的國(guó)家。據(jù)相關(guān)數(shù)據(jù)統(tǒng)計(jì)，中國(guó)細(xì)胞治療市場(chǎng)空間將由2021年的13億元增長(zhǎng)至2030年的584億元，年均增速高達(dá)53%。預(yù)計(jì)未來(lái)10年將成為國(guó)內(nèi)細(xì)胞治療產(chǎn)業(yè)的快速增長(zhǎng)期。</p> <p style="text-indent: 2em;"><strong>規(guī)范、扶持，推進(jìn)產(chǎn)業(yè)健康快速發(fā)展</strong></p> <p style="text-indent: 2em;">經(jīng)過(guò)10余年發(fā)展，我國(guó)細(xì)胞治療領(lǐng)域已進(jìn)入規(guī)范化發(fā)展階段。</p> <p style="text-indent: 2em;">細(xì)胞治療被認(rèn)為是創(chuàng)新藥領(lǐng)域研發(fā)的細(xì)分賽道。相關(guān)主管部門(mén)近兩年出臺(tái)了多份與細(xì)胞治療產(chǎn)品有關(guān)的申報(bào)指導(dǎo)，推進(jìn)相關(guān)產(chǎn)品的審評(píng)審批。國(guó)內(nèi)細(xì)胞治療產(chǎn)品從申報(bào)到生產(chǎn)各環(huán)節(jié)，獲得較為明確的指引。各地政府也不斷出臺(tái)扶持、鼓勵(lì)細(xì)胞治療產(chǎn)品研發(fā)和上市的相關(guān)政策。</p> <p style="text-indent: 2em;">目前，國(guó)內(nèi)細(xì)胞治療領(lǐng)域的研究成為全球研發(fā)的重要力量。與此同時(shí)，專家認(rèn)為，作為新興產(chǎn)業(yè)，細(xì)胞治療產(chǎn)業(yè)仍面臨不少挑戰(zhàn)。盡管技術(shù)持續(xù)獲得突破，但細(xì)胞治療產(chǎn)品真正要實(shí)現(xiàn)普及并非易事。一方面，細(xì)胞治療技術(shù)轉(zhuǎn)化應(yīng)用的產(chǎn)業(yè)鏈還不夠成熟，另一方面是由于其成本還比較高。</p> <p style="text-indent: 2em;">鄭純林介紹：“如果相關(guān)設(shè)備及耗材能實(shí)現(xiàn)國(guó)產(chǎn)化，將會(huì)大大降低細(xì)胞治療產(chǎn)品的成本?！睋?jù)了解，國(guó)內(nèi)細(xì)胞治療產(chǎn)品研發(fā)生產(chǎn)所涉及的一些設(shè)備，以及配套的細(xì)胞培養(yǎng)耗材等，仍有不少需要進(jìn)口。</p> <p style="text-indent: 2em;">臨床資源的緊缺也制約了細(xì)胞治療技術(shù)的臨床轉(zhuǎn)化應(yīng)用。天津藥物研究院副院長(zhǎng)閆鳳英說(shuō)：“與傳統(tǒng)化學(xué)藥物相比，細(xì)胞治療產(chǎn)品具有細(xì)胞來(lái)源及種類多、生產(chǎn)制備過(guò)程要求嚴(yán)格等特點(diǎn)，因此需要建立符合細(xì)胞治療產(chǎn)品特點(diǎn)的研發(fā)、生產(chǎn)、臨床前評(píng)價(jià)及臨床研究全鏈條、規(guī)范化、標(biāo)準(zhǔn)化的質(zhì)量控制及保障體系。同時(shí)，需要設(shè)立一些專業(yè)的臨床研究型醫(yī)療機(jī)構(gòu)或病房開(kāi)展系統(tǒng)規(guī)范的臨床試驗(yàn)。在對(duì)細(xì)胞治療產(chǎn)品的基礎(chǔ)生物學(xué)特性及作用機(jī)理等深入研究的基礎(chǔ)上，開(kāi)展臨床安全性和有效性研究?！?/p> <p style="text-indent: 2em;">中國(guó)科學(xué)院分子細(xì)胞科學(xué)卓越創(chuàng)新中心研究員惠利健建議，在細(xì)胞治療的創(chuàng)新和轉(zhuǎn)化過(guò)程中，通過(guò)原始創(chuàng)新建立細(xì)胞治療新技術(shù)，完善細(xì)胞質(zhì)量安全評(píng)價(jià)、臨床研究規(guī)范及產(chǎn)品標(biāo)準(zhǔn)，進(jìn)而推動(dòng)細(xì)胞治療的臨床轉(zhuǎn)化應(yīng)用，推進(jìn)細(xì)胞治療產(chǎn)業(yè)的健康快速發(fā)展。</p><div id="i0eggeegg" class="zdfy clearfix"></div><center><table border="0" align="center" width="40%"><tr></tr></table></center> <div id="i0eggeegg" class="box_pic"></div> <div id="i0eggeegg" class="edit cf">(責(zé)編：王雅蝶、初梓瑞)</div> <p class="paper_num"><em class="section-common-share-wrap">分享讓更多人看到 <i class="btn_share_common"><img src="/img/2020wbc/imgs/share.png" alt=""></i> </em></p> </div> <div id="i0eggeegg" class="rm_relevant rm_download cf"> <h5><span></span>客戶端下載</h5> <ul> <li><a target="_blank"><img src="/img/2020wbc/imgs/icon_download_rmrb.png" width="70" height="70" alt="">人民日?qǐng)?bào)</a></li> <li><a target="_blank"><img src="/img/2020wbc/imgs/icon_download_rmwj1.png" width="70" height="70" 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