新聞動態
天勤生物及友芝友、鼎康生物創新藥全鏈條研發啟動儀式圓滿落地
- 2025-04-11
4月(yue)11日，由武(wu)(wu)漢產(chan)業創新發(fa)展(zhan)研(yan)究院(yuan)(yuan)創新藥(yao)(yao)物(wu)發(fa)現與(yu)非臨床(chuang)評價服務平臺（天(tian)勤(qin)生物(wu)）攜(xie)手武(wu)(wu)漢友(you)(you)芝(zhi)友(you)(you)生物(wu)制藥(yao)(yao)股份有(you)限公司(si)（以下(xia)稱“友(you)(you)芝(zhi)友(you)(you)生物(wu)”）、鼎康（武(wu)(wu)漢）生物(wu)醫藥(yao)(yao)有(you)限公司(si)（以下(xia)稱“鼎康生物(wu)”）的(de)(de)(de)(de)戰(zhan)略合作簽約暨創新藥(yao)(yao)全鏈條(tiao)研(yan)發(fa)啟(qi)動(dong)儀式在武(wu)(wu)創院(yuan)(yuan)本部(bu)大(da)樓圓滿落幕。三(san)方以“技(ji)術(shu)共(gong)融(rong)、生態共(gong)建”為(wei)核心(xin)理(li)念，成(cheng)(cheng)功(gong)簽署戰(zhan)略合作協(xie)議，標(biao)(biao)(biao)志著武(wu)(wu)漢生物(wu)醫藥(yao)(yao)全鏈條(tiao)協(xie)同創新邁入實質性突破(po)階段(duan)，為(wei)中(zhong)(zhong)國(guo)原研(yan)藥(yao)(yao)高質量(liang)發(fa)展(zhan)注(zhu)入新動(dong)能(neng)(neng)(neng)。本次創新藥(yao)(yao)全鏈條(tiao)研(yan)發(fa)啟(qi)動(dong)儀式，也是(shi)武(wu)(wu)創院(yuan)(yuan)三(san)周(zhou)年(nian)系列(lie)活動(dong)之一。現場，友(you)(you)芝(zhi)友(you)(you)生物(wu)介紹了(le)雙抗領域(yu)的(de)(de)(de)(de) “技(ji)術(shu)-臨床(chuang)-生產(chan)”全鏈條(tiao)優勢，及結(jie)構創新、靶點差異化(hua)及規模化(hua)能(neng)(neng)(neng)力帶(dai)來的(de)(de)(de)(de)生產(chan)成(cheng)(cheng)本優勢；天(tian)勤(qin)生物(wu)重(zhong)點展(zhan)示(shi)了(le)潰(kui)瘍性結(jie)腸炎(yan)（UC）猴模型、A型血友(you)(you)病猴模型，這些模型成(cheng)(cheng)功(gong)模擬疾病病理(li)特征，為(wei)相(xiang)關藥(yao)(yao)物(wu)研(yan)發(fa)提(ti)供高置信度評價體系；鼎康生物(wu)作為(wei)國(guo)際(ji)質量(liang)標(biao)(biao)(biao)準的(de)(de)(de)(de)CDMO 智造伙伴，可提(ti)供從(cong)細(xi)胞株到(dao)商業化(hua)生產(chan)的(de)(de)(de)(de)“端(duan)(duan)到(dao)端(duan)(duan)”服務，助(zhu)力中(zhong)(zhong)國(guo)創新藥(yao)(yao)企(qi)高效對接FDA、EMA等國(guo)際(ji)監管(guan)標(biao)(biao)(biao)準。隨后的(de)(de)(de)(de)圓桌對話中(zhong)(zhong)，三(san)方圍繞“中(zhong)(zhong)國(guo)生物(wu)醫藥(yao)(yao)的(de)(de)(de)(de)下(xia)一個黃金十(shi)年(nian)：全鏈條(tiao)創新需要怎(zen)樣的(de)(de)(de)(de)革(ge)命”進行了(le)深度討(tao)論，并(bing)達成(cheng)(cheng)共(gong)識(shi)：唯有(you)打破(po)“孤島式研(yan)發(fa)”，方能(neng)(neng)(neng)實...
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邁向全球，勤啟新章 | 天勤生物參加2025美國毒理學會年會
- 2025-03-28
2025年(nian)3月16日至20日，第64屆美國毒(du)理學(xue)(xue)會(hui)（SOT）年(nian)會(hui)在(zai)(zai)(zai)美國奧蘭多(duo)順利(li)召開。天(tian)勤生(sheng)(sheng)物(wu)團隊(dui)攜多(duo)項研(yan)究(jiu)成(cheng)果參會(hui)，通(tong)過壁(bi)報展示、技術(shu)研(yan)討及行業(ye)交(jiao)流(liu)，與(yu)(yu)(yu)國際同行分享毒(du)理學(xue)(xue)領域(yu)(yu)的(de)(de)(de)(de)研(yan)究(jiu)成(cheng)果，進一(yi)步(bu)提升了(le)(le)天(tian)勤生(sheng)(sheng)物(wu)在(zai)(zai)(zai)國際毒(du)理學(xue)(xue)界的(de)(de)(de)(de)參與(yu)(yu)(yu)度。會(hui)議(yi)期間，天(tian)勤生(sheng)(sheng)物(wu)以三組專題壁(bi)報呈現了(le)(le)其在(zai)(zai)(zai)藥(yao)物(wu)安(an)全性(xing)評價(jia)領域(yu)(yu)的(de)(de)(de)(de)研(yan)究(jiu)進展。食蟹(xie)猴(hou)生(sheng)(sheng)殖與(yu)(yu)(yu)發(fa)育毒(du)性(xing)評價(jia)體系(xi)(xi)的(de)(de)(de)(de)驗證和(he)優化(hua)《Validation Study on Non-clinical Reproductive and Developmental Toxicity Evaluation System in Cynomolgus Monkeys》總(zong)結了(le)(le)天(tian)勤生(sheng)(sheng)物(wu)在(zai)(zai)(zai)食蟹(xie)猴(hou)生(sheng)(sheng)殖與(yu)(yu)(yu)發(fa)育毒(du)性(xing)研(yan)究(jiu)中(zhong)所建(jian)立(li)的(de)(de)(de)(de)整套驗證和(he)評價(jia)系(xi)(xi)統，按照ICHS5（R3）指導(dao)原則(ze)的(de)(de)(de)(de)要求，通(tong)過對兩種致畸陽性(xing)藥(yao)物(wu)的(de)(de)(de)(de)評價(jia)驗證體系(xi)(xi)的(de)(de)(de)(de)研(yan)究(jiu)，建(jian)立(li)了(le)(le)食蟹(xie)猴(hou)EFD和(he)ePPND的(de)(de)(de)(de)背景數(shu)據(ju)、試驗體系(xi)(xi)等，并采用電子化(hua)數(shu)據(ju)采集，為目前正在(zai)(zai)(zai)開展的(de)(de)(de)(de)幾項正式注冊申報的(de)(de)(de)(de)ePPND試驗提供了(le)(le)大量基礎(chu)背景資料。抗(kang)體藥(yao)物(wu)在(zai)(zai)(zai)兔(tu)圍產期生(sheng)(sheng)殖與(yu)(yu)(yu)發(fa)育毒(du)性(xing)中(zhong)的(de)(de)(de)(de)研(yan)究(jiu)《Study on the Perinatal Developmental ...
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天勤生物攜手耀海生物達成戰略合作
- 2025-03-28
近(jin)日，湖北天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)科技(ji)(ji)集(ji)團股份有(you)限公(gong)司（以下簡稱"天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)"）與(yu)(yu)江蘇耀海生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)制藥(yao)(yao)(yao)有(you)限公(gong)司（以下簡稱"耀海生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)"）正式(shi)達(da)成(cheng)戰(zhan)略(lve)合作(zuo)。此(ci)(ci)次(ci)合作(zuo)依托武(wu)創(chuang)(chuang)院/天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)創(chuang)(chuang)新(xin)藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)發(fa)現與(yu)(yu)非(fei)臨(lin)床(chuang)評(ping)價(jia)服(fu)(fu)務(wu)平(ping)臺(tai)，整(zheng)合雙方優勢資源(yuan)，致力(li)于為(wei)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)醫(yi)藥(yao)(yao)(yao)產(chan)業提(ti)供覆蓋研(yan)發(fa)全(quan)周期(qi)的(de)一站(zhan)式(shi)創(chuang)(chuang)新(xin)服(fu)(fu)務(wu)。 作(zuo)為(wei)此(ci)(ci)次(ci)合作(zuo)的(de)核(he)心支(zhi)撐，武(wu)創(chuang)(chuang)院/天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)創(chuang)(chuang)新(xin)藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)發(fa)現與(yu)(yu)非(fei)臨(lin)床(chuang)評(ping)價(jia)服(fu)(fu)務(wu)平(ping)臺(tai)憑(ping)借其在(zai)(zai)藥(yao)(yao)(yao)代動(dong)力(li)學、藥(yao)(yao)(yao)效(xiao)(xiao)學、生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)檢測(ce)及藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)毒(du)理與(yu)(yu)安全(quan)性評(ping)價(jia)等領(ling)域(yu)的(de)專業能力(li)，為(wei)雙方技(ji)(ji)術(shu)(shu)協(xie)同注入(ru)強勁動(dong)能。基(ji)于此(ci)(ci)，耀海生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)將(jiang)充(chong)分發(fa)揮其在(zai)(zai)重(zhong)組蛋白/多肽、核(he)酸(suan)藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)、納(na)米抗體等前(qian)沿領(ling)域(yu)的(de)技(ji)(ji)術(shu)(shu)優勢，結合天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)在(zai)(zai)GLP實驗室建設及臨(lin)床(chuang)前(qian)研(yan)究方面的(de)經驗積累，共同構建高質高效(xiao)(xiao)的(de)研(yan)發(fa)服(fu)(fu)務(wu)體系。 通過深度(du)合作(zuo)，雙方將(jiang)重(zhong)點優化藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)發(fa)流(liu)程，助力(li)企業縮短研(yan)發(fa)周期(qi)、降低綜合成(cheng)本，同時強化研(yan)發(fa)數(shu)據的(de)合規(gui)性與(yu)(yu)可靠(kao)性。天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)符合國際標(biao)準(zhun)的(de)試驗平(ping)臺(tai)將(jiang)為(wei)項目提(ti)供技(ji)(ji)術(shu)(shu)保障，而耀海生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)領(ling)先的(de)微(wei)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)表達(da)系統(tong)技(ji)(ji)術(shu)(shu)則(ze)進(jin)一步(bu)提(ti)升了(le)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)的(de)研(yan)發(fa)效(xiao)(xiao)率與(yu)(yu)質量穩定性。 此(ci)(ci)次(ci)戰(zhan)略(lve)合作(zuo)是生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)醫(yi)藥(yao)(yao)(yao)領(ling)域(yu)產(chan)學研(yan)協(xie)同創(chuang)(chuang)新(xin)的(de)典范，凸顯了(le)武(wu)創(chuang)(chuang)院/天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)創(chuang)(chuang)新(xin)藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)發(fa)現與(yu)(yu)非(fei)臨(lin)床(chuang)...
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天勤生物榮登武漢市首批研發型企業入庫名單
- 2025-03-28
近日(ri)，武漢市(shi)科(ke)技(ji)創新(xin)(xin)(xin)(xin)(xin)(xin)局(ju)發(fa)(fa)布"2025年(nian)(nian)度(du)首(shou)批研(yan)(yan)發(fa)(fa)型企業擬(ni)入(ru)(ru)(ru)庫名單(dan)"，天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)憑借自(zi)主創新(xin)(xin)(xin)(xin)(xin)(xin)能力(li)(li)和產(chan)業化轉(zhuan)化效(xiao)率成(cheng)功入(ru)(ru)(ru)圍。此(ci)次(ci)遴選(xuan)(xuan)聚焦(jiao)新(xin)(xin)(xin)(xin)(xin)(xin)業態、新(xin)(xin)(xin)(xin)(xin)(xin)模(mo)式、新(xin)(xin)(xin)(xin)(xin)(xin)服(fu)務(wu)(wu)、新(xin)(xin)(xin)(xin)(xin)(xin)技(ji)術(shu)"四新(xin)(xin)(xin)(xin)(xin)(xin)"培育目標，全市(shi)僅15家企業入(ru)(ru)(ru)選(xuan)(xuan)。作(zuo)為湖北省生(sheng)(sheng)(sheng)物(wu)(wu)(wu)醫藥(yao)(yao)非(fei)臨床安全評價(jia)(jia)領域的(de)標桿企業，天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)的(de)入(ru)(ru)(ru)圍標志著其在研(yan)(yan)發(fa)(fa)深度(du)與市(shi)場廣度(du)雙重維(wei)度(du)獲得權威(wei)認可(ke)(ke)，彰顯出"硬核科(ke)技(ji)+商(shang)業落地"的(de)復合競爭(zheng)力(li)(li)。自(zi)2009年(nian)(nian)創立以來(lai)，天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)始(shi)終將"研(yan)(yan)發(fa)(fa)立企"作(zuo)為核心戰略，構建(jian)起"基礎研(yan)(yan)究(jiu)(jiu)(jiu)-技(ji)術(shu)攻關-產(chan)業轉(zhuan)化"的(de)全鏈條創新(xin)(xin)(xin)(xin)(xin)(xin)體系。研(yan)(yan)發(fa)(fa)投(tou)入(ru)(ru)(ru)連年(nian)(nian)增(zeng)加(jia)，建(jian)成(cheng)由(you)多名國內(nei)外頂尖專家組成(cheng)的(de)研(yan)(yan)發(fa)(fa)指導團隊，累計獲得專利(li)74項，在猴生(sheng)(sheng)(sheng)殖(zhi)與發(fa)(fa)育毒(du)性(xing)研(yan)(yan)究(jiu)(jiu)(jiu)、CNS大動(dong)物(wu)(wu)(wu)藥(yao)(yao)效(xiao)學(xue)研(yan)(yan)究(jiu)(jiu)(jiu)，毒(du)性(xing)病理等領域形(xing)成(cheng)了(le)關鍵(jian)技(ji)術(shu)儲(chu)備，可(ke)(ke)開展(zhan)GLP條件下的(de)小(xiao)分(fen)子、大分(fen)子、ADC、細胞和基因治療、兒科(ke)藥(yao)(yao)、中藥(yao)(yao)等藥(yao)(yao)物(wu)(wu)(wu)的(de)安全性(xing)評價(jia)(jia)、藥(yao)(yao)代動(dong)力(li)(li)學(xue)研(yan)(yan)究(jiu)(jiu)(jiu)、生(sheng)(sheng)(sheng)物(wu)(wu)(wu)檢測與毒(du)性(xing)病理診斷分(fen)析等專業化的(de)CRO服(fu)務(wu)(wu)，已成(cheng)功助(zhu)力(li)(li)海內(nei)外多個創新(xin)(xin)(xin)(xin)(xin)(xin)藥(yao)(yao)獲得臨床批件。此(ci)次(ci)入(ru)(ru)(ru)圍武漢市(shi)首(shou)批研(yan)(yan)發(fa)(fa)型企業入(ru)(ru)(ru)庫名單(dan)，也是對天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)十五年(nian)(nian)來(lai)創新(xin)(xin)(xin)(xin)(xin)(xin)實力(li)(li)的(de)認證。天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)將以此(ci)次(ci)入(ru)(ru)(ru)選(xuan)(xuan)為契機，深化"產(chan)學(xue)研(yan)(yan)"協同創新(xin)(xin)(xin)(xin)(xin)(xin)機制，加(jia)速搭建(jian)藥(yao)(yao)物(wu)(wu)(wu)研(yan)(yan)發(fa)(fa)全周期(qi)技(ji)術(shu)服(fu)務(wu)(wu)平臺。...
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天勤生物助力甫康藥業雙特異性抗體CVL006注射液獲批臨床
- 2025-01-13
2024年12月20日，天(tian)勤(qin)生(sheng)物(wu)提供(gong)非臨(lin)床研(yan)(yan)(yan)究(jiu)服(fu)(fu)務支持的(de)(de)甫康藥(yao)業(ye)的(de)(de)CVL006注(zhu)射(she)液(ye)，在(zai)晚期實(shi)體瘤(liu)患(huan)(huan)者中的(de)(de)安(an)全性(xing)(xing)、耐受(shou)性(xing)(xing)、藥(yao)代動(dong)力學和(he)療(liao)效(xiao)的(de)(de)開(kai)放(fang)、多中心的(de)(de)I期臨(lin)床研(yan)(yan)(yan)究(jiu)在(zai)上海高博腫瘤(liu)醫(yi)院和(he)中國醫(yi)學科學院腫瘤(liu)醫(yi)院啟(qi)(qi)動(dong)患(huan)(huan)者招募。CVL006注(zhu)射(she)液(ye)從2024年Q1在(zai)天(tian)勤(qin)生(sheng)物(wu)啟(qi)(qi)動(dong)研(yan)(yan)(yan)究(jiu)至獲批臨(lin)床僅(jin)僅(jin)10個月時間，天(tian)勤(qin)生(sheng)物(wu)武(wu)漢(han)分公司提供(gong)了(le)包(bao)括全套(tao)毒理研(yan)(yan)(yan)究(jiu)、藥(yao)代動(dong)力學研(yan)(yan)(yan)究(jiu)和(he)組(zu)織交叉反應(ying)試驗(yan)（TCR）等全套(tao)的(de)(de)非臨(lin)床研(yan)(yan)(yan)究(jiu)服(fu)(fu)務工作，為CVL006注(zhu)射(she)液(ye)的(de)(de)快速獲批提供(gong)了(le)專(zhuan)業(ye)保障。 天(tian)勤(qin)生(sheng)物(wu)武(wu)漢(han)分公司以科學嚴謹的(de)(de)服(fu)(fu)務支持了(le)多個抗(kang)(kang)體類(lei)藥(yao)物(wu)的(de)(de)安(an)全性(xing)(xing)評價(jia)，高質高效(xiao)完成(cheng)了(le)其非臨(lin)床藥(yao)代動(dong)力學和(he)安(an)全性(xing)(xing)評價(jia)研(yan)(yan)(yan)究(jiu)。本次(ci)CVL006注(zhu)射(she)液(ye)項目(mu)的(de)(de)圓滿快速的(de)(de)交付也再次(ci)體現了(le)天(tian)勤(qin)生(sheng)物(wu)在(zai)抗(kang)(kang)體藥(yao)物(wu)非臨(lin)床安(an)全研(yan)(yan)(yan)究(jiu)領(ling)域的(de)(de)強大的(de)(de)項目(mu)承接能力。目(mu)前，天(tian)勤(qin)生(sheng)物(wu)已累計完成(cheng)多個抗(kang)(kang)體類(lei)藥(yao)物(wu)安(an)全性(xing)(xing)評價(jia)項目(mu)，包(bao)括單(dan)抗(kang)(kang)、雙抗(kang)(kang)、多抗(kang)(kang)、ADC等，覆(fu)蓋腫瘤(liu)、感染性(xing)(xing)疾(ji)病(bing)、代謝、免疫等多個疾(ji)病(bing)領(ling)域。
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天勤生物7項中檢院能力驗證均以最高評價等級通過！
- 2024-12-19
近日，天勤(qin)生物(wu)武(wu)(wu)漢(han)(han)分(fen)公(gong)(gong)(gong)司在(zai)中(zhong)(zhong)國(guo)食品藥品檢(jian)(jian)(jian)(jian)定研究院組織(zhi)的多(duo)項(xiang)(xiang)年度(du)能(neng)(neng)力驗(yan)證(zheng)(zheng)項(xiang)(xiang)目中(zhong)(zhong)表現(xian)優異(yi)。涉及毒(du)性(xing)病(bing)理(li)(li)、臨(lin)(lin)床(chuang)檢(jian)(jian)(jian)(jian)驗(yan)和(he)生物(wu)分(fen)析的多(duo)個(ge)(ge)(ge)檢(jian)(jian)(jian)(jian)測領域，且參加的7個(ge)(ge)(ge)項(xiang)(xiang)目均以該項(xiang)(xiang)目最(zui)(zui)高(gao)評價等(deng)級通過(guo)。1.毒(du)性(xing)病(bing)理(li)(li)在(zai)毒(du)性(xing)病(bing)理(li)(li)形(xing)態學檢(jian)(jian)(jian)(jian)查(cha)能(neng)(neng)力驗(yan)證(zheng)(zheng)（NIFDC-PT-478）檢(jian)(jian)(jian)(jian)查(cha)的過(guo)程中(zhong)(zhong)，天勤(qin)生物(wu)武(wu)(wu)漢(han)(han)分(fen)公(gong)(gong)(gong)司多(duo)名(ming)(ming)具有豐富實(shi)驗(yan)動物(wu)毒(du)性(xing)病(bing)理(li)(li)診斷經驗(yan)的研究人員嚴格遵(zun)循國(guo)際標準(zhun)操作規程，確(que)保(bao)毒(du)性(xing)病(bing)理(li)(li)形(xing)態得(de)(de)(de)到了(le)最(zui)(zui)準(zhun)確(que)、最(zui)(zui)可靠的解讀，使得(de)(de)(de)該項(xiang)(xiang)目評分(fen)名(ming)(ming)列(lie)前茅(mao)，并以最(zui)(zui)高(gao)評價等(deng)級“優秀”順(shun)利通過(guo)。天勤(qin)生物(wu)武(wu)(wu)漢(han)(han)分(fen)公(gong)(gong)(gong)司能(neng)(neng)夠從92家參評機(ji)構中(zhong)(zhong)脫(tuo)穎而出，獲得(de)(de)(de)“優秀”評價，充分(fen)體現(xian)了(le)公(gong)(gong)(gong)司在(zai)病(bing)理(li)(li)學研究領域的技術(shu)實(shi)力和(he)服務(wu)質量。2.臨(lin)(lin)床(chuang)檢(jian)(jian)(jian)(jian)驗(yan)在(zai)血(xue)(xue)清(qing)中(zhong)(zhong)生化(hua)指(zhi)標（NIFDC-PT-509）、血(xue)(xue)液學指(zhi)標（NIFDC-PT-475）、血(xue)(xue)凝學指(zhi)標（NIFDC-PT-476）和(he)尿生化(hua)指(zhi)標（NIFDC-PT-477）四個(ge)(ge)(ge)關鍵項(xiang)(xiang)目的能(neng)(neng)力驗(yan)證(zheng)(zheng)過(guo)程中(zhong)(zhong)，天勤(qin)生物(wu)武(wu)(wu)漢(han)(han)分(fen)公(gong)(gong)(gong)司提交(jiao)了(le)全部37個(ge)(ge)(ge)能(neng)(neng)力驗(yan)證(zheng)(zheng)指(zhi)標，且所(suo)有項(xiang)(xiang)目均以滿分(fen)100分(fen)通過(guo)，最(zui)(zui)終獲得(de)(de)(de)“滿意”的最(zui)(zui)高(gao)等(deng)級認定。在(zai)臨(lin)(lin)床(chuang)檢(jian)(jian)(jian)(jian)驗(yan)領域，天勤(qin)生物(wu)武(wu)(wu)漢(han)(han)公(gong)(gong)(gong)司不(bu)僅配備了(le)先(xian)進的儀器設備，還建立(li)了(le)完善的實(shi)驗(yan)室質量控制體系(xi)，并擁有一支(zhi)高(gao)...
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天勤生物助力正大天晴抗腫瘤新藥“TQB3909”獲批更長周期臨床
- 2024-11-29
近日(ri)，正大天(tian)晴(qing)藥(yao)業集團(tuan)股(gu)份有限(xian)(xian)公司（簡稱(cheng)“正大天(tian)晴(qing)”）自(zi)主(zhu)研(yan)(yan)發(fa)的(de)(de)1類(lei)新藥(yao)——BCL-2抑制(zhi)(zhi)劑TQB3909片，獲(huo)批了(le)更長(chang)(chang)周(zhou)期臨(lin)床(chuang)試(shi)驗許(xu)可。天(tian)勤(qin)生(sheng)(sheng)物(wu)子公司湖北天(tian)勤(qin)鑫(xin)圣生(sheng)(sheng)物(wu)科技有限(xian)(xian)公司（以(yi)下簡稱(cheng)“天(tian)勤(qin)鑫(xin)圣”）為TQB3909的(de)(de)臨(lin)床(chuang)前研(yan)(yan)發(fa)提(ti)供了(le)關鍵的(de)(de)長(chang)(chang)周(zhou)期毒(du)理試(shi)驗服務，助力其成功獲(huo)批臨(lin)床(chuang)。TQB3909是正大天(tian)晴(qing)自(zi)主(zhu)研(yan)(yan)發(fa)的(de)(de)一款BCL-2抑制(zhi)(zhi)劑，擬(ni)聯(lian)合化療用于急性(xing)淋巴細(xi)胞白血病(bing)（ALL）患者的(de)(de)治療。BCL-2家族蛋白可以(yi)通過阻止線粒體外(wai)膜通透化（MOMP）從(cong)而抑制(zhi)(zhi)腫瘤細(xi)胞凋亡(wang)，其過表達與(yu)癌癥的(de)(de)耐藥(yao)性(xing)的(de)(de)形成密切相關。通過抑制(zhi)(zhi)BCL-2與(yu)促(cu)凋亡(wang)蛋白（如BAK）的(de)(de)結(jie)合，抑制(zhi)(zhi)BCL-2依賴性(xing)腫瘤的(de)(de)生(sheng)(sheng)長(chang)(chang)，從(cong)而發(fa)揮抗腫瘤的(de)(de)作(zuo)用。自(zi)合作(zuo)項目(mu)立項之初(chu)，天(tian)勤(qin)鑫(xin)圣專家技術團(tuan)隊與(yu)正大天(tian)晴(qing)研(yan)(yan)發(fa)團(tuan)隊精誠合作(zuo)，根據TQB3909特(te)點(dian)及申(shen)報要求(qiu)，科學合理地(di)設(she)計了(le)試(shi)驗劑量，嚴控試(shi)驗風險(xian)點(dian)，最終(zhong)在GLP 的(de)(de)實驗室(shi)環境和操作(zuo)規范下，高質、高效(xiao)地(di)完成了(le)TQB3909的(de)(de)3個(ge)月鼠加犬長(chang)(chang)周(zhou)期給(gei)藥(yao)毒(du)性(xing)試(shi)驗，加速(su)了(le)新藥(yao)研(yan)(yan)發(fa)進程，為TQB3909獲(huo)批臨(lin)床(chuang)提(ti)供了(le)專業保障。此次TQB3909獲(huo)批臨(lin)床(chuang)，既顯示了(le)正大天(tian)晴(qing)在抗腫瘤藥(yao)物(wu)自(zi)主(zhu)研(yan)(yan)發(fa)領域的(de)(de)創(chuang)新...
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獲優秀結果！天勤鑫圣再創佳績
- 2024-11-29
毒(du)(du)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)理(li)(li)形(xing)(xing)(xing)態學(xue)(xue)(xue)檢(jian)查(cha)是藥(yao)物(wu)臨床前(qian)毒(du)(du)理(li)(li)學(xue)(xue)(xue)評價的(de)(de)(de)(de)重要(yao)環節(jie)。為(wei)在毒(du)(du)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)理(li)(li)診(zhen)(zhen)(zhen)斷領域(yu)持續保持高(gao)水平，天(tian)(tian)(tian)勤生物(wu)子公司(si)湖北天(tian)(tian)(tian)勤鑫(xin)圣(sheng)生物(wu)科技(ji)有限(xian)公司(si)（以下稱(cheng)“天(tian)(tian)(tian)勤鑫(xin)圣(sheng)”）參(can)加了(le)由中(zhong)國食品藥(yao)品檢(jian)定研(yan)究(jiu)院組(zu)織的(de)(de)(de)(de)2024年度毒(du)(du)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)理(li)(li)形(xing)(xing)(xing)態學(xue)(xue)(xue)檢(jian)查(cha)能(neng)力驗(yan)(yan)(yan)證(zheng)項(xiang)目(mu)（NIFDC-PT-478），最(zui)終結(jie)果為(wei)“優(you)秀”。本(ben)次(ci)(ci)能(neng)力驗(yan)(yan)(yan)證(zheng)項(xiang)目(mu)共(gong)準備了(le)A、 B、 C 三套(tao)案例(li)(li)(li)，每(mei)套(tao)案例(li)(li)(li)含 10 個(ge)病(bing)(bing)(bing)(bing)例(li)(li)(li)，均包含腫(zhong)(zhong)瘤(liu)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)變(bian) 4 例(li)(li)(li)和非腫(zhong)(zhong)瘤(liu)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)變(bian) 6 例(li)(li)(li)，天(tian)(tian)(tian)勤鑫(xin)圣(sheng)（實驗(yan)(yan)(yan)室代(dai)碼468）在本(ben)次(ci)(ci)能(neng)力驗(yan)(yan)(yan)證(zheng)項(xiang)目(mu)中(zhong)分配(pei)到(dao)A套(tao)案例(li)(li)(li)。收到(dao)病(bing)(bing)(bing)(bing)例(li)(li)(li)全(quan)切片圖像后(hou)，天(tian)(tian)(tian)勤鑫(xin)圣(sheng)快速組(zu)織病(bing)(bing)(bing)(bing)理(li)(li)研(yan)究(jiu)部的(de)(de)(de)(de)病(bing)(bing)(bing)(bing)理(li)(li)診(zhen)(zhen)(zhen)斷人(ren)員，在短時間內完成了(le)10個(ge)病(bing)(bing)(bing)(bing)例(li)(li)(li)的(de)(de)(de)(de)病(bing)(bing)(bing)(bing)理(li)(li)形(xing)(xing)(xing)態學(xue)(xue)(xue)檢(jian)查(cha)并提交結(jie)果，最(zui)終，4 個(ge)腫(zhong)(zhong)瘤(liu)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)例(li)(li)(li)和6個(ge)非腫(zhong)(zhong)瘤(liu)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)例(li)(li)(li)的(de)(de)(de)(de)病(bing)(bing)(bing)(bing)理(li)(li)診(zhen)(zhen)(zhen)斷結(jie)果均獲得遠(yuan)超于(yu)平均分的(de)(de)(de)(de)優(you)異成績，并以總分91.75分的(de)(de)(de)(de)成績在全(quan)部92家參(can)評機構(gou)中(zhong)位列第四。本(ben)次(ci)(ci)能(neng)力驗(yan)(yan)(yan)證(zheng)項(xiang)目(mu)的(de)(de)(de)(de)結(jie)果表明(ming)，天(tian)(tian)(tian)勤鑫(xin)圣(sheng)能(neng)夠準確使用(yong)病(bing)(bing)(bing)(bing)理(li)(li)學(xue)(xue)(xue)專業術(shu)語對組(zu)織病(bing)(bing)(bing)(bing)理(li)(li)學(xue)(xue)(xue)診(zhen)(zhen)(zhen)斷、診(zhen)(zhen)(zhen)斷要(yao)點描述、相關病(bing)(bing)(bing)(bing)理(li)(li)機制和其他病(bing)(bing)(bing)(bing)變(bian)描述四個(ge)方面進行毒(du)(du)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)理(li)(li)形(xing)(xing)(xing)態學(xue)(xue)(xue)檢(jian)查(cha)，并進行病(bing)(bing)(bing)(bing)變(bian)的(de)(de)(de)(de)綜合闡述和發病(bing)(bing)(bing)(bing)機制分析。參(can)加本(ben)次(ci)(ci)能(neng)力驗(yan)(yan)(yan)證(zheng)項(xiang)目(mu)，既(ji)體現出天(tian)(tian)(tian)勤鑫(xin)圣(sheng)的(de)(de)(de)(de)病(bing)(bing)(bing)(bing)理(li)(li)診(zhen)(zhen)(zhen)斷團隊擁有較強的(de)(de)(de)(de)毒(du)(du)性(xing)(xing)(xing)病(bing)(bing)(bing)(bing)理(li)(li)診(zhen)(zhen)(zhen)斷和分析病(bing)(bing)(bing)(bing)變(bian)...
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天勤生物助力智翔金泰GR1802注射液兒童/青少年特應性皮炎適應癥獲批臨床
- 2024-11-01
重(zhong)慶智(zhi)翔(xiang)金泰(tai)(tai)生(sheng)物(wu)(wu)(wu)制藥股份有限(xian)公(gong)司（以下稱“智(zhi)翔(xiang)金泰(tai)(tai)”）自主研(yan)(yan)發的(de)GR1802注(zhu)射液(ye)是(shi)一(yi)(yi)款重(zhong)組全(quan)人(ren)源(yuan)抗IL-4Rα單克(ke)隆抗體，能(neng)(neng)特異性(xing)(xing)結(jie)合細(xi)胞表(biao)面人(ren)IL-4Rα，阻斷IL-4、IL-13與IL-4Rα的(de)結(jie)合，抑(yi)制下游STAT6磷酸(suan)化，抑(yi)制CD23上調，從而抑(yi)制由IL-4或IL-13介導(dao)的(de)Th2型(xing)炎(yan)癥反應(ying)(ying)。該產品擬(ni)用(yong)于(yu)具IL-4、IL-13過表(biao)達的(de)自身免疫性(xing)(xing)疾病的(de)治(zhi)療(liao)。 特應(ying)(ying)性(xing)(xing)皮炎(yan)是(shi)GR1802注(zhu)射液(ye)的(de)適(shi)(shi)(shi)應(ying)(ying)癥之一(yi)(yi)。近日(ri)，該適(shi)(shi)(shi)應(ying)(ying)癥將適(shi)(shi)(shi)應(ying)(ying)人(ren)群范圍擴增(zeng)至(zhi)兒童/青少(shao)年，并獲(huo)得(de)了(le)臨床默示許可。天(tian)勤(qin)生(sheng)物(wu)(wu)(wu)子公(gong)司湖北天(tian)勤(qin)鑫(xin)(xin)(xin)圣生(sheng)物(wu)(wu)(wu)科(ke)技有限(xian)公(gong)司（以下稱“天(tian)勤(qin)鑫(xin)(xin)(xin)圣”）針對(dui)該適(shi)(shi)(shi)應(ying)(ying)癥群體開(kai)展(zhan)了(le)幼(you)(you)齡動(dong)(dong)(dong)物(wu)(wu)(wu)非(fei)臨床毒(du)性(xing)(xing)研(yan)(yan)究(jiu)(jiu)，助力其順利獲(huo)批(pi)。 兒童生(sheng)長發育的(de)特殊性(xing)(xing)，對(dui)動(dong)(dong)(dong)物(wu)(wu)(wu)毒(du)性(xing)(xing)試(shi)驗(yan)研(yan)(yan)究(jiu)(jiu)提出(chu)了(le)更高的(de)要求。天(tian)勤(qin)鑫(xin)(xin)(xin)圣毒(du)理研(yan)(yan)究(jiu)(jiu)團(tuan)隊基于(yu)豐富(fu)的(de)幼(you)(you)齡動(dong)(dong)(dong)物(wu)(wu)(wu)實驗(yan)經驗(yan)，開(kai)展(zhan)了(le)全(quan)面而深入(ru)的(de)幼(you)(you)齡動(dong)(dong)(dong)物(wu)(wu)(wu)發育毒(du)性(xing)(xing)研(yan)(yan)究(jiu)(jiu)，以人(ren)源(yuan)化小(xiao)鼠為試(shi)驗(yan)對(dui)象，科(ke)學(xue)設計(ji)試(shi)驗(yan)方案，嚴格設計(ji)試(shi)驗(yan)分組，技術操作(zuo)嚴謹規范，在項目運行過程中展(zhan)現出(chu)了(le)天(tian)勤(qin)鑫(xin)(xin)(xin)圣一(yi)(yi)貫的(de)技術水準和(he)服務(wu)(wu)能(neng)(neng)力。 長期扎(zha)實的(de)試(shi)驗(yan)研(yan)(yan)究(jiu)(jiu)，也讓(rang)幼(you)(you)齡動(dong)(dong)(dong)物(wu)(wu)(wu)試(shi)驗(yan)成為了(le)天(tian)勤(qin)生(sheng)物(wu)(wu)(wu)的(de)王牌服務(wu)(wu)之一(yi)(yi)。截止至(zhi)今天(tian)，天(tian)勤(qin)生(sheng)物(wu)(wu)(wu)...
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天勤生物助力寶船生物BC011抗體注射液獲批臨床
- 2024-09-13
近日，上(shang)海寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)醫(yi)藥科技有限公司自主研(yan)發(fa)(fa)的(de)BC011抗(kang)(kang)體(ti)(ti)注射(she)(she)液成功獲得國家藥品(pin)監(jian)督管理局（NMPA）的(de)臨(lin)床(chuang)試驗(yan)批準(zhun)，其適應癥為(wei)晚期實體(ti)(ti)瘤(liu)。天勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)武漢分(fen)公司作為(wei)寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)的(de)合(he)作伙伴，為(wei)該項目(mu)提(ti)供了非臨(lin)床(chuang)全套的(de)毒理、藥代試驗(yan)服務(wu)(wu)，助力(li)(li)其成功通過 IND 審批進(jin)(jin)入(ru)臨(lin)床(chuang)試驗(yan)階段。 BC011抗(kang)(kang)體(ti)(ti)注射(she)(she)液由寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)自主研(yan)發(fa)(fa)的(de)全人源單(dan)克(ke)隆抗(kang)(kang)體(ti)(ti)。BC011具有抗(kang)(kang)體(ti)(ti)Fc端介導的(de)ADCC作用，可(ke)減(jian)少Treg細(xi)胞(bao)(bao)，增(zeng)加CD8+ T細(xi)胞(bao)(bao)對(dui)腫(zhong)(zhong)瘤(liu)的(de)殺(sha)(sha)傷(shang)活性，也(ye)(ye)可(ke)直接殺(sha)(sha)傷(shang)腫(zhong)(zhong)瘤(liu)細(xi)胞(bao)(bao)。體(ti)(ti)外藥效(xiao)研(yan)究顯示，BC011特異性較高(gao)，可(ke)抑制(zhi)腫(zhong)(zhong)瘤(liu)細(xi)胞(bao)(bao)浸潤(run)(run)Treg細(xi)胞(bao)(bao) ,使腫(zhong)(zhong)瘤(liu)浸潤(run)(run)的(de)CTL比例和數量增(zeng)加，引起(qi)CTL/Treg 的(de)比值升(sheng)高(gao)，調節腫(zhong)(zhong)瘤(liu)免(mian)疫微(wei)環境(jing)更有利于殺(sha)(sha)傷(shang)腫(zhong)(zhong)瘤(liu)，從(cong)而展現出較強的(de)抗(kang)(kang)腫(zhong)(zhong)瘤(liu)活性，且安(an)全性良好，將為(wei)腫(zhong)(zhong)瘤(liu)治療提(ti)供一(yi)種(zhong)全新(xin)的(de)策略(lve)。 高(gao)效(xiao)源于協(xie)同(tong)，成功源于經驗(yan)。BC011抗(kang)(kang)體(ti)(ti)注射(she)(she)液成功獲批臨(lin)床(chuang)試驗(yan)，不(bu)僅是對(dui)寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)自主創新(xin)能力(li)(li)的(de)肯定，也(ye)(ye)是天勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)臨(lin)床(chuang)前(qian)研(yan)發(fa)(fa)服務(wu)(wu)平(ping)臺(tai)綜合(he)能力(li)(li)的(de)見證。天勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)作為(wei)專業的(de)一(yi)站式(shi)生(sheng)(sheng)(sheng)物(wu)醫(yi)藥臨(lin)床(chuang)前(qian)綜合(he)研(yan)發(fa)(fa)服務(wu)(wu)CRO，多年(nian)來在創新(xin)之(zhi)路上(shang)不(bu)斷精進(jin)(jin)，積累了眾多國內知名醫(yi)藥企業及...
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