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11日，由武(wu)漢(han)(han)(han)產(chan)(chan)業創(chuang)新發(fa)展(zhan)研(yan)(yan)究院(yuan)創(chuang)新藥(yao)(yao)物(wu)(wu)發(fa)現與非臨床評價服務平臺(tai)（天(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)）攜手武(wu)漢(han)(han)(han)友(you)(you)芝友(you)(you)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)制藥(yao)(yao)股(gu)份有限公司（以(yi)下(xia)稱(cheng)(cheng)“友(you)(you)芝友(you)(you)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)”）、鼎(ding)康（武(wu)漢(han)(han)(han)）生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)醫(yi)藥(yao)(yao)有限公司（以(yi)下(xia)稱(cheng)(cheng)“鼎(ding)康生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)”）的(de)戰略(lve)(lve)合(he)(he)作(zuo)簽約暨創(chuang)新藥(yao)(yao)全(quan)鏈(lian)條(tiao)研(yan)(yan)發(fa)啟動儀式(shi)在武(wu)創(chuang)院(yuan)本(ben)部大樓圓(yuan)滿落幕。三(san)方以(yi)“技術(shu)共(gong)融(rong)、生(sheng)(sheng)(sheng)(sheng)態共(gong)建”為核心理念，成(cheng)功簽署(shu)戰略(lve)(lve)合(he)(he)作(zuo)協議(yi)，標(biao)志著武(wu)漢(han)(han)(han)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)醫(yi)藥(yao)(yao)全(quan)鏈(lian)條(tiao)協同創(chuang)新邁入(ru)實(shi)質(zhi)(zhi)性突破階(jie)段，為中(zhong)國原研(yan)(yan)藥(yao)(yao)高質(zhi)(zhi)量發(fa)展(zhan)注入(ru)新動能(neng)。本(ben)次(ci)創(chuang)新藥(yao)(yao)全(quan)鏈(lian)條(tiao)研(yan)(yan)發(fa)啟動儀式(shi)，也是(shi)武(wu)創(chuang)院(yuan)三(san)周年系列活動之(zhi)一(yi)。現場，友(you)(you)芝友(you)(you)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)介紹了(le)雙抗(kang)領域的(de) “技術(shu)-臨床-生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)”全(quan)鏈(lian)條(tiao)優(you)勢(shi)，及結構(gou)創(chuang)新、靶(ba)點差異化及規模(mo)化能(neng)力帶(dai)來(lai)的(de)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)成(cheng)本(ben)優(you)勢(shi)；天(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)重點展(zhan)示了(le)潰瘍性結腸炎（UC）猴模(mo)型、A型血友(you)(you)病猴模(mo)型，這(zhe)些(xie)模(mo)型成(cheng)功模(mo)擬疾病病理特征(zheng)，為相關(guan)藥(yao)(yao)物(wu)(wu)研(yan)(yan)發(fa)提(ti)供高置(zhi)信(xin)度(du)評價體(ti)系；鼎(ding)康生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)作(zuo)為國際質(zhi)(zhi)量標(biao)準的(de)CDMO 智造伙伴(ban)，可提(ti)供從(cong)細(xi)胞株到商業化生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)的(de)“端到端”服務，助力中(zhong)國創(chuang)新藥(yao)(yao)企高效對接FDA、EMA等國際監(jian)管標(biao)準。隨后(hou)的(de)圓(yuan)桌對話中(zhong)，三(san)方圍繞“中(zhong)國生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)醫(yi)藥(yao)(yao)的(de)下(xia)一(yi)個黃(huang)金十年：全(quan)鏈(lian)條(tiao)創(chuang)新需要怎(zen)樣(yang)的(de)革命”進行了(le)深度(du)討論(lun)，并(bing)達成(cheng)共(gong)識：唯有打破“孤島式(shi)研(yan)(yan)發(fa)”，方能(neng)實(shi)...
- 查看詳情+
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3月16日至20日，第64屆美(mei)國(guo)(guo)毒(du)理學會(hui)（SOT）年會(hui)在美(mei)國(guo)(guo)奧蘭多順(shun)利召開。天勤(qin)(qin)(qin)生(sheng)(sheng)物團(tuan)隊攜多項研(yan)(yan)究(jiu)成(cheng)果參(can)會(hui)，通過(guo)(guo)壁(bi)報展(zhan)示(shi)、技術研(yan)(yan)討及行(xing)業交流，與國(guo)(guo)際同行(xing)分(fen)享(xiang)毒(du)理學領(ling)域的(de)(de)(de)(de)研(yan)(yan)究(jiu)成(cheng)果，進一(yi)步提升(sheng)了天勤(qin)(qin)(qin)生(sheng)(sheng)物在國(guo)(guo)際毒(du)理學界(jie)的(de)(de)(de)(de)參(can)與度。會(hui)議(yi)期間，天勤(qin)(qin)(qin)生(sheng)(sheng)物以(yi)三組專題壁(bi)報呈現(xian)了其在藥物安全(quan)性(xing)評價(jia)領(ling)域的(de)(de)(de)(de)研(yan)(yan)究(jiu)進展(zhan)。食(shi)蟹(xie)猴生(sheng)(sheng)殖(zhi)與發育(yu)毒(du)性(xing)評價(jia)體系的(de)(de)(de)(de)驗(yan)證和(he)優(you)化(hua)《Validation Study on Non-clinical Reproductive and Developmental Toxicity Evaluation System in Cynomolgus Monkeys》總(zong)結了天勤(qin)(qin)(qin)生(sheng)(sheng)物在食(shi)蟹(xie)猴生(sheng)(sheng)殖(zhi)與發育(yu)毒(du)性(xing)研(yan)(yan)究(jiu)中所建(jian)立的(de)(de)(de)(de)整套驗(yan)證和(he)評價(jia)系統，按照(zhao)ICHS5（R3）指導原則的(de)(de)(de)(de)要求，通過(guo)(guo)對兩(liang)種致畸陽(yang)性(xing)藥物的(de)(de)(de)(de)評價(jia)驗(yan)證體系的(de)(de)(de)(de)研(yan)(yan)究(jiu)，建(jian)立了食(shi)蟹(xie)猴EFD和(he)ePPND的(de)(de)(de)(de)背(bei)景(jing)數據(ju)、試驗(yan)體系等，并采(cai)用電子化(hua)數據(ju)采(cai)集(ji)，為(wei)目前正(zheng)在開展(zhan)的(de)(de)(de)(de)幾(ji)項正(zheng)式注冊申報的(de)(de)(de)(de)ePPND試驗(yan)提供(gong)了大(da)量(liang)基(ji)礎背(bei)景(jing)資(zi)料。抗體藥物在兔圍產(chan)期生(sheng)(sheng)殖(zhi)與發育(yu)毒(du)性(xing)中的(de)(de)(de)(de)研(yan)(yan)究(jiu)《Study on the Perinatal Developmental ...
- 查看詳情+
天勤生物攜手耀海生物達成戰略合作
- 2025-03-28
近日，湖(hu)北天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)科技集團股份有限(xian)公(gong)(gong)司(si)(si)（以下簡稱"天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)"）與(yu)(yu)江蘇耀(yao)海(hai)生(sheng)(sheng)物(wu)(wu)制藥(yao)(yao)有限(xian)公(gong)(gong)司(si)(si)（以下簡稱"耀(yao)海(hai)生(sheng)(sheng)物(wu)(wu)"）正式達(da)成(cheng)戰(zhan)(zhan)略(lve)(lve)合作(zuo)。此(ci)(ci)次(ci)合作(zuo)依托(tuo)武(wu)(wu)(wu)創(chuang)院/天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)創(chuang)新藥(yao)(yao)物(wu)(wu)發現(xian)(xian)與(yu)(yu)非(fei)(fei)臨床評價服(fu)(fu)務(wu)(wu)平(ping)(ping)臺(tai)(tai)，整合雙方(fang)優(you)(you)勢資(zi)源，致力(li)于(yu)為(wei)生(sheng)(sheng)物(wu)(wu)醫藥(yao)(yao)產(chan)業(ye)(ye)提(ti)供覆蓋研(yan)(yan)(yan)發全(quan)周期(qi)(qi)的一(yi)站式創(chuang)新服(fu)(fu)務(wu)(wu)。 作(zuo)為(wei)此(ci)(ci)次(ci)合作(zuo)的核(he)心支撐，武(wu)(wu)(wu)創(chuang)院/天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)創(chuang)新藥(yao)(yao)物(wu)(wu)發現(xian)(xian)與(yu)(yu)非(fei)(fei)臨床評價服(fu)(fu)務(wu)(wu)平(ping)(ping)臺(tai)(tai)憑借其(qi)在藥(yao)(yao)代(dai)動(dong)力(li)學、藥(yao)(yao)效(xiao)(xiao)學、生(sheng)(sheng)物(wu)(wu)檢測及藥(yao)(yao)物(wu)(wu)毒理(li)與(yu)(yu)安全(quan)性評價等領(ling)域的專業(ye)(ye)能力(li)，為(wei)雙方(fang)技術協同(tong)注入強(qiang)勁動(dong)能。基于(yu)此(ci)(ci)，耀(yao)海(hai)生(sheng)(sheng)物(wu)(wu)將(jiang)充分發揮其(qi)在重(zhong)組蛋白/多肽、核(he)酸藥(yao)(yao)物(wu)(wu)、納米抗(kang)體(ti)(ti)等前沿(yan)領(ling)域的技術優(you)(you)勢，結合天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)在GLP實驗室建設及臨床前研(yan)(yan)(yan)究(jiu)方(fang)面的經驗積累，共同(tong)構建高(gao)質(zhi)高(gao)效(xiao)(xiao)的研(yan)(yan)(yan)發服(fu)(fu)務(wu)(wu)體(ti)(ti)系。 通過深度合作(zuo)，雙方(fang)將(jiang)重(zhong)點優(you)(you)化(hua)藥(yao)(yao)物(wu)(wu)研(yan)(yan)(yan)發流程，助力(li)企業(ye)(ye)縮短(duan)研(yan)(yan)(yan)發周期(qi)(qi)、降(jiang)低綜(zong)合成(cheng)本，同(tong)時強(qiang)化(hua)研(yan)(yan)(yan)發數據的合規性與(yu)(yu)可靠性。天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)符(fu)合國(guo)際標準的試(shi)驗平(ping)(ping)臺(tai)(tai)將(jiang)為(wei)項(xiang)目提(ti)供技術保障，而耀(yao)海(hai)生(sheng)(sheng)物(wu)(wu)領(ling)先(xian)的微(wei)生(sheng)(sheng)物(wu)(wu)表達(da)系統技術則進一(yi)步(bu)提(ti)升了生(sheng)(sheng)物(wu)(wu)藥(yao)(yao)物(wu)(wu)的研(yan)(yan)(yan)發效(xiao)(xiao)率(lv)與(yu)(yu)質(zhi)量穩定性。 此(ci)(ci)次(ci)戰(zhan)(zhan)略(lve)(lve)合作(zuo)是生(sheng)(sheng)物(wu)(wu)醫藥(yao)(yao)領(ling)域產(chan)學研(yan)(yan)(yan)協同(tong)創(chuang)新的典范，凸顯了武(wu)(wu)(wu)創(chuang)院/天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)創(chuang)新藥(yao)(yao)物(wu)(wu)發現(xian)(xian)與(yu)(yu)非(fei)(fei)臨床...
- 查看詳情+
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，武漢市(shi)科技(ji)(ji)創(chuang)(chuang)新(xin)局發(fa)布"2025年度(du)首批研(yan)(yan)發(fa)型企(qi)(qi)(qi)業(ye)(ye)擬入(ru)庫名單"，天(tian)勤(qin)生(sheng)物(wu)(wu)憑(ping)借自(zi)主創(chuang)(chuang)新(xin)能力(li)和產業(ye)(ye)化(hua)(hua)轉(zhuan)化(hua)(hua)效率成功入(ru)圍。此次(ci)(ci)遴選(xuan)聚焦新(xin)業(ye)(ye)態(tai)、新(xin)模式、新(xin)服(fu)務、新(xin)技(ji)(ji)術"四新(xin)"培育目標，全市(shi)僅15家(jia)企(qi)(qi)(qi)業(ye)(ye)入(ru)選(xuan)。作為(wei)湖北省生(sheng)物(wu)(wu)醫藥(yao)(yao)非(fei)臨床安(an)全評價(jia)領(ling)域的(de)(de)標桿(gan)企(qi)(qi)(qi)業(ye)(ye)，天(tian)勤(qin)生(sheng)物(wu)(wu)的(de)(de)入(ru)圍標志(zhi)著其(qi)在研(yan)(yan)發(fa)深(shen)度(du)與市(shi)場廣(guang)度(du)雙重(zhong)維度(du)獲(huo)得(de)權威認可，彰顯出"硬核(he)科技(ji)(ji)+商業(ye)(ye)落地"的(de)(de)復合競爭力(li)。自(zi)2009年創(chuang)(chuang)立(li)以來(lai)，天(tian)勤(qin)生(sheng)物(wu)(wu)始(shi)終將"研(yan)(yan)發(fa)立(li)企(qi)(qi)(qi)"作為(wei)核(he)心戰(zhan)略，構建(jian)起"基(ji)礎研(yan)(yan)究(jiu)-技(ji)(ji)術攻關(guan)-產業(ye)(ye)轉(zhuan)化(hua)(hua)"的(de)(de)全鏈條(tiao)創(chuang)(chuang)新(xin)體系。研(yan)(yan)發(fa)投入(ru)連年增加(jia)，建(jian)成由多(duo)名國內外頂尖專(zhuan)家(jia)組成的(de)(de)研(yan)(yan)發(fa)指導團(tuan)隊，累計獲(huo)得(de)專(zhuan)利74項，在猴(hou)生(sheng)殖(zhi)與發(fa)育毒(du)性(xing)(xing)(xing)研(yan)(yan)究(jiu)、CNS大(da)動物(wu)(wu)藥(yao)(yao)效學研(yan)(yan)究(jiu)，毒(du)性(xing)(xing)(xing)病理(li)等(deng)領(ling)域形成了關(guan)鍵(jian)技(ji)(ji)術儲備，可開展GLP條(tiao)件下的(de)(de)小分子、大(da)分子、ADC、細(xi)胞和基(ji)因治(zhi)療(liao)、兒科藥(yao)(yao)、中藥(yao)(yao)等(deng)藥(yao)(yao)物(wu)(wu)的(de)(de)安(an)全性(xing)(xing)(xing)評價(jia)、藥(yao)(yao)代動力(li)學研(yan)(yan)究(jiu)、生(sheng)物(wu)(wu)檢測與毒(du)性(xing)(xing)(xing)病理(li)診斷分析(xi)等(deng)專(zhuan)業(ye)(ye)化(hua)(hua)的(de)(de)CRO服(fu)務，已成功助力(li)海內外多(duo)個(ge)創(chuang)(chuang)新(xin)藥(yao)(yao)獲(huo)得(de)臨床批件。此次(ci)(ci)入(ru)圍武漢市(shi)首批研(yan)(yan)發(fa)型企(qi)(qi)(qi)業(ye)(ye)入(ru)庫名單，也是對天(tian)勤(qin)生(sheng)物(wu)(wu)十五年來(lai)創(chuang)(chuang)新(xin)實力(li)的(de)(de)認證。天(tian)勤(qin)生(sheng)物(wu)(wu)將以此次(ci)(ci)入(ru)選(xuan)為(wei)契機，深(shen)化(hua)(hua)"產學研(yan)(yan)"協同創(chuang)(chuang)新(xin)機制，加(jia)速搭建(jian)藥(yao)(yao)物(wu)(wu)研(yan)(yan)發(fa)全周期(qi)技(ji)(ji)術服(fu)務平臺(tai)。...
- 查看詳情+
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(ri)，天(tian)(tian)勤(qin)(qin)生(sheng)物(wu)(wu)提供非(fei)(fei)(fei)臨(lin)(lin)床(chuang)(chuang)(chuang)研究(jiu)服務支持的(de)(de)甫康藥(yao)(yao)業的(de)(de)CVL006注(zhu)(zhu)射(she)(she)液(ye)(ye)，在晚期實體(ti)瘤(liu)患者中的(de)(de)安全(quan)性、耐(nai)受性、藥(yao)(yao)代(dai)動(dong)力(li)學和(he)療效(xiao)的(de)(de)開放、多中心的(de)(de)I期臨(lin)(lin)床(chuang)(chuang)(chuang)研究(jiu)在上海高(gao)博腫(zhong)瘤(liu)醫(yi)院和(he)中國(guo)醫(yi)學科(ke)(ke)學院腫(zhong)瘤(liu)醫(yi)院啟動(dong)患者招募。CVL006注(zhu)(zhu)射(she)(she)液(ye)(ye)從(cong)2024年Q1在天(tian)(tian)勤(qin)(qin)生(sheng)物(wu)(wu)啟動(dong)研究(jiu)至獲(huo)批(pi)臨(lin)(lin)床(chuang)(chuang)(chuang)僅僅10個(ge)(ge)月時間，天(tian)(tian)勤(qin)(qin)生(sheng)物(wu)(wu)武(wu)(wu)漢分公司(si)提供了包括全(quan)套毒理研究(jiu)、藥(yao)(yao)代(dai)動(dong)力(li)學研究(jiu)和(he)組織(zhi)交叉反應試驗(yan)（TCR）等(deng)全(quan)套的(de)(de)非(fei)(fei)(fei)臨(lin)(lin)床(chuang)(chuang)(chuang)研究(jiu)服務工(gong)作，為(wei)CVL006注(zhu)(zhu)射(she)(she)液(ye)(ye)的(de)(de)快(kuai)速獲(huo)批(pi)提供了專(zhuan)業保(bao)障。 天(tian)(tian)勤(qin)(qin)生(sheng)物(wu)(wu)武(wu)(wu)漢分公司(si)以(yi)科(ke)(ke)學嚴謹的(de)(de)服務支持了多個(ge)(ge)抗(kang)體(ti)類(lei)藥(yao)(yao)物(wu)(wu)的(de)(de)安全(quan)性評價(jia)，高(gao)質高(gao)效(xiao)完(wan)成(cheng)了其非(fei)(fei)(fei)臨(lin)(lin)床(chuang)(chuang)(chuang)藥(yao)(yao)代(dai)動(dong)力(li)學和(he)安全(quan)性評價(jia)研究(jiu)。本次(ci)(ci)CVL006注(zhu)(zhu)射(she)(she)液(ye)(ye)項(xiang)目(mu)的(de)(de)圓滿快(kuai)速的(de)(de)交付也再次(ci)(ci)體(ti)現了天(tian)(tian)勤(qin)(qin)生(sheng)物(wu)(wu)在抗(kang)體(ti)藥(yao)(yao)物(wu)(wu)非(fei)(fei)(fei)臨(lin)(lin)床(chuang)(chuang)(chuang)安全(quan)研究(jiu)領域的(de)(de)強大的(de)(de)項(xiang)目(mu)承接能力(li)。目(mu)前，天(tian)(tian)勤(qin)(qin)生(sheng)物(wu)(wu)已累計完(wan)成(cheng)多個(ge)(ge)抗(kang)體(ti)類(lei)藥(yao)(yao)物(wu)(wu)安全(quan)性評價(jia)項(xiang)目(mu)，包括單抗(kang)、雙(shuang)抗(kang)、多抗(kang)、ADC等(deng)，覆蓋腫(zhong)瘤(liu)、感染性疾病(bing)、代(dai)謝、免疫等(deng)多個(ge)(ge)疾病(bing)領域。
- 查看詳情+
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(tian)(tian)勤生(sheng)(sheng)(sheng)物(wu)(wu)武(wu)漢(han)分(fen)(fen)(fen)公(gong)司(si)在(zai)中國食品藥品檢(jian)(jian)定研究(jiu)院組織的(de)(de)多(duo)(duo)項(xiang)(xiang)年度(du)能(neng)(neng)(neng)力(li)驗(yan)(yan)(yan)證項(xiang)(xiang)目(mu)(mu)(mu)中表現優異。涉及(ji)毒(du)性(xing)病(bing)理、臨(lin)床(chuang)(chuang)檢(jian)(jian)驗(yan)(yan)(yan)和生(sheng)(sheng)(sheng)物(wu)(wu)分(fen)(fen)(fen)析的(de)(de)多(duo)(duo)個(ge)檢(jian)(jian)測領域(yu)，且(qie)參(can)(can)加的(de)(de)7個(ge)項(xiang)(xiang)目(mu)(mu)(mu)均(jun)以(yi)該項(xiang)(xiang)目(mu)(mu)(mu)最(zui)高評(ping)(ping)價等級通過(guo)。1.毒(du)性(xing)病(bing)理在(zai)毒(du)性(xing)病(bing)理形(xing)態學檢(jian)(jian)查能(neng)(neng)(neng)力(li)驗(yan)(yan)(yan)證（NIFDC-PT-478）檢(jian)(jian)查的(de)(de)過(guo)程(cheng)中，天(tian)(tian)勤生(sheng)(sheng)(sheng)物(wu)(wu)武(wu)漢(han)分(fen)(fen)(fen)公(gong)司(si)多(duo)(duo)名具有(you)豐富(fu)實(shi)驗(yan)(yan)(yan)動物(wu)(wu)毒(du)性(xing)病(bing)理診斷經驗(yan)(yan)(yan)的(de)(de)研究(jiu)人員嚴格(ge)遵循國際標準操作(zuo)規程(cheng)，確保毒(du)性(xing)病(bing)理形(xing)態得(de)到(dao)了最(zui)準確、最(zui)可靠的(de)(de)解(jie)讀，使得(de)該項(xiang)(xiang)目(mu)(mu)(mu)評(ping)(ping)分(fen)(fen)(fen)名列前茅，并(bing)以(yi)最(zui)高評(ping)(ping)價等級“優秀”順利通過(guo)。天(tian)(tian)勤生(sheng)(sheng)(sheng)物(wu)(wu)武(wu)漢(han)分(fen)(fen)(fen)公(gong)司(si)能(neng)(neng)(neng)夠(gou)從(cong)92家參(can)(can)評(ping)(ping)機構(gou)中脫穎而出，獲(huo)得(de)“優秀”評(ping)(ping)價，充(chong)分(fen)(fen)(fen)體現了公(gong)司(si)在(zai)病(bing)理學研究(jiu)領域(yu)的(de)(de)技術(shu)實(shi)力(li)和服務質(zhi)量(liang)。2.臨(lin)床(chuang)(chuang)檢(jian)(jian)驗(yan)(yan)(yan)在(zai)血(xue)清中生(sheng)(sheng)(sheng)化指(zhi)(zhi)標（NIFDC-PT-509）、血(xue)液學指(zhi)(zhi)標（NIFDC-PT-475）、血(xue)凝學指(zhi)(zhi)標（NIFDC-PT-476）和尿生(sheng)(sheng)(sheng)化指(zhi)(zhi)標（NIFDC-PT-477）四(si)個(ge)關鍵(jian)項(xiang)(xiang)目(mu)(mu)(mu)的(de)(de)能(neng)(neng)(neng)力(li)驗(yan)(yan)(yan)證過(guo)程(cheng)中，天(tian)(tian)勤生(sheng)(sheng)(sheng)物(wu)(wu)武(wu)漢(han)分(fen)(fen)(fen)公(gong)司(si)提交了全部37個(ge)能(neng)(neng)(neng)力(li)驗(yan)(yan)(yan)證指(zhi)(zhi)標，且(qie)所有(you)項(xiang)(xiang)目(mu)(mu)(mu)均(jun)以(yi)滿分(fen)(fen)(fen)100分(fen)(fen)(fen)通過(guo)，最(zui)終(zhong)獲(huo)得(de)“滿意(yi)”的(de)(de)最(zui)高等級認定。在(zai)臨(lin)床(chuang)(chuang)檢(jian)(jian)驗(yan)(yan)(yan)領域(yu)，天(tian)(tian)勤生(sheng)(sheng)(sheng)物(wu)(wu)武(wu)漢(han)公(gong)司(si)不僅配(pei)備了先(xian)進(jin)的(de)(de)儀器設備，還建立了完善的(de)(de)實(shi)驗(yan)(yan)(yan)室質(zhi)量(liang)控制體系，并(bing)擁有(you)一支高...
- 查看詳情+
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，正(zheng)大天(tian)(tian)晴(qing)藥(yao)(yao)(yao)業集團股份有(you)限(xian)公(gong)司(si)(si)（簡稱(cheng)(cheng)“正(zheng)大天(tian)(tian)晴(qing)”）自(zi)主(zhu)研(yan)發(fa)的(de)(de)(de)1類新(xin)藥(yao)(yao)(yao)——BCL-2抑(yi)制(zhi)劑TQB3909片，獲批(pi)了更(geng)長(chang)周期(qi)臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)許可(ke)。天(tian)(tian)勤生物子公(gong)司(si)(si)湖北天(tian)(tian)勤鑫圣(sheng)生物科技有(you)限(xian)公(gong)司(si)(si)（以(yi)下簡稱(cheng)(cheng)“天(tian)(tian)勤鑫圣(sheng)”）為TQB3909的(de)(de)(de)臨(lin)(lin)(lin)床(chuang)(chuang)前研(yan)發(fa)提供了關(guan)(guan)鍵的(de)(de)(de)長(chang)周期(qi)毒(du)(du)理試驗(yan)服務，助(zhu)力其成(cheng)功(gong)獲批(pi)臨(lin)(lin)(lin)床(chuang)(chuang)。TQB3909是正(zheng)大天(tian)(tian)晴(qing)自(zi)主(zhu)研(yan)發(fa)的(de)(de)(de)一款BCL-2抑(yi)制(zhi)劑，擬聯合(he)化(hua)(hua)療用(yong)于急性(xing)(xing)淋巴細(xi)胞白血病（ALL）患者的(de)(de)(de)治(zhi)療。BCL-2家族蛋白可(ke)以(yi)通過(guo)阻止(zhi)線粒體外膜(mo)通透化(hua)(hua)（MOMP）從而抑(yi)制(zhi)腫(zhong)(zhong)瘤(liu)(liu)細(xi)胞凋亡，其過(guo)表達與(yu)癌癥的(de)(de)(de)耐(nai)藥(yao)(yao)(yao)性(xing)(xing)的(de)(de)(de)形成(cheng)密(mi)切(qie)相關(guan)(guan)。通過(guo)抑(yi)制(zhi)BCL-2與(yu)促凋亡蛋白（如(ru)BAK）的(de)(de)(de)結合(he)，抑(yi)制(zhi)BCL-2依賴(lai)性(xing)(xing)腫(zhong)(zhong)瘤(liu)(liu)的(de)(de)(de)生長(chang)，從而發(fa)揮抗腫(zhong)(zhong)瘤(liu)(liu)的(de)(de)(de)作用(yong)。自(zi)合(he)作項目立項之初，天(tian)(tian)勤鑫圣(sheng)專家技術團隊與(yu)正(zheng)大天(tian)(tian)晴(qing)研(yan)發(fa)團隊精誠合(he)作，根(gen)據TQB3909特點及申(shen)報要(yao)求(qiu)，科學合(he)理地設計了試驗(yan)劑量(liang)，嚴(yan)控試驗(yan)風(feng)險點，最終在(zai)GLP 的(de)(de)(de)實驗(yan)室環(huan)境和(he)操作規范下，高(gao)質(zhi)、高(gao)效地完成(cheng)了TQB3909的(de)(de)(de)3個月鼠加(jia)犬長(chang)周期(qi)給藥(yao)(yao)(yao)毒(du)(du)性(xing)(xing)試驗(yan)，加(jia)速(su)了新(xin)藥(yao)(yao)(yao)研(yan)發(fa)進程，為TQB3909獲批(pi)臨(lin)(lin)(lin)床(chuang)(chuang)提供了專業保障。此次TQB3909獲批(pi)臨(lin)(lin)(lin)床(chuang)(chuang)，既(ji)顯示了正(zheng)大天(tian)(tian)晴(qing)在(zai)抗腫(zhong)(zhong)瘤(liu)(liu)藥(yao)(yao)(yao)物自(zi)主(zhu)研(yan)發(fa)領(ling)域的(de)(de)(de)創(chuang)新(xin)...
- 查看詳情+
獲優秀結果！天勤鑫圣再創佳績
- 2024-11-29
毒(du)性(xing)(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)形(xing)態學(xue)(xue)(xue)檢查(cha)是藥(yao)物(wu)臨床前(qian)毒(du)理(li)(li)(li)(li)(li)(li)學(xue)(xue)(xue)評價的(de)重(zhong)要(yao)環節。為(wei)在(zai)毒(du)性(xing)(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)診(zhen)斷(duan)(duan)領域持續(xu)保持高(gao)水平，天(tian)(tian)勤(qin)(qin)生物(wu)子公(gong)司湖北(bei)天(tian)(tian)勤(qin)(qin)鑫(xin)圣(sheng)生物(wu)科技有限(xian)公(gong)司（以下(xia)稱“天(tian)(tian)勤(qin)(qin)鑫(xin)圣(sheng)”）參(can)加了由中(zhong)國食品藥(yao)品檢定研究院組織(zhi)(zhi)的(de)2024年度毒(du)性(xing)(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)形(xing)態學(xue)(xue)(xue)檢查(cha)能(neng)力(li)(li)驗(yan)(yan)證(zheng)(zheng)項(xiang)目（NIFDC-PT-478），最(zui)終結果為(wei)“優秀”。本(ben)次(ci)能(neng)力(li)(li)驗(yan)(yan)證(zheng)(zheng)項(xiang)目共(gong)準(zhun)備了A、 B、 C 三套(tao)(tao)案例，每(mei)套(tao)(tao)案例含(han) 10 個(ge)病(bing)(bing)(bing)例，均(jun)(jun)包含(han)腫(zhong)瘤(liu)性(xing)(xing)病(bing)(bing)(bing)變(bian)(bian) 4 例和(he)非(fei)腫(zhong)瘤(liu)性(xing)(xing)病(bing)(bing)(bing)變(bian)(bian) 6 例，天(tian)(tian)勤(qin)(qin)鑫(xin)圣(sheng)（實(shi)驗(yan)(yan)室代碼468）在(zai)本(ben)次(ci)能(neng)力(li)(li)驗(yan)(yan)證(zheng)(zheng)項(xiang)目中(zhong)分(fen)(fen)配(pei)到A套(tao)(tao)案例。收到病(bing)(bing)(bing)例全(quan)切片圖像(xiang)后，天(tian)(tian)勤(qin)(qin)鑫(xin)圣(sheng)快速組織(zhi)(zhi)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)研究部(bu)的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)診(zhen)斷(duan)(duan)人員，在(zai)短時(shi)間內完成了10個(ge)病(bing)(bing)(bing)例的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)形(xing)態學(xue)(xue)(xue)檢查(cha)并提(ti)交結果，最(zui)終，4 個(ge)腫(zhong)瘤(liu)性(xing)(xing)病(bing)(bing)(bing)例和(he)6個(ge)非(fei)腫(zhong)瘤(liu)性(xing)(xing)病(bing)(bing)(bing)例的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)診(zhen)斷(duan)(duan)結果均(jun)(jun)獲得遠超于平均(jun)(jun)分(fen)(fen)的(de)優異成績，并以總分(fen)(fen)91.75分(fen)(fen)的(de)成績在(zai)全(quan)部(bu)92家參(can)評機(ji)構中(zhong)位列第四。本(ben)次(ci)能(neng)力(li)(li)驗(yan)(yan)證(zheng)(zheng)項(xiang)目的(de)結果表明，天(tian)(tian)勤(qin)(qin)鑫(xin)圣(sheng)能(neng)夠準(zhun)確(que)使用病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)學(xue)(xue)(xue)專業術(shu)語(yu)對(dui)組織(zhi)(zhi)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)學(xue)(xue)(xue)診(zhen)斷(duan)(duan)、診(zhen)斷(duan)(duan)要(yao)點描述、相關病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)機(ji)制(zhi)和(he)其他病(bing)(bing)(bing)變(bian)(bian)描述四個(ge)方面進行毒(du)性(xing)(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)形(xing)態學(xue)(xue)(xue)檢查(cha)，并進行病(bing)(bing)(bing)變(bian)(bian)的(de)綜(zong)合闡述和(he)發(fa)病(bing)(bing)(bing)機(ji)制(zhi)分(fen)(fen)析(xi)。參(can)加本(ben)次(ci)能(neng)力(li)(li)驗(yan)(yan)證(zheng)(zheng)項(xiang)目，既(ji)體現(xian)出天(tian)(tian)勤(qin)(qin)鑫(xin)圣(sheng)的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)診(zhen)斷(duan)(duan)團(tuan)隊擁有較強的(de)毒(du)性(xing)(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)(li)(li)診(zhen)斷(duan)(duan)和(he)分(fen)(fen)析(xi)病(bing)(bing)(bing)變(bian)(bian)...
- 查看詳情+
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)慶智翔(xiang)金(jin)泰生(sheng)(sheng)物制(zhi)藥股(gu)份有限公司（以(yi)下稱(cheng)“智翔(xiang)金(jin)泰”）自(zi)主研發的(de)(de)GR1802注(zhu)射液是一(yi)款重(zhong)組(zu)全人(ren)源抗(kang)IL-4Rα單克隆(long)抗(kang)體，能特異性(xing)(xing)結合細胞(bao)表面(mian)人(ren)IL-4Rα，阻斷IL-4、IL-13與(yu)IL-4Rα的(de)(de)結合，抑制(zhi)下游STAT6磷酸化，抑制(zhi)CD23上(shang)調，從而(er)抑制(zhi)由IL-4或IL-13介導的(de)(de)Th2型炎(yan)癥(zheng)反應(ying)。該(gai)(gai)產(chan)品(pin)擬用于(yu)具IL-4、IL-13過表達(da)的(de)(de)自(zi)身免疫性(xing)(xing)疾病的(de)(de)治療。 特應(ying)性(xing)(xing)皮(pi)炎(yan)是GR1802注(zhu)射液的(de)(de)適(shi)應(ying)癥(zheng)之一(yi)。近(jin)日，該(gai)(gai)適(shi)應(ying)癥(zheng)將適(shi)應(ying)人(ren)群范(fan)圍(wei)擴增至兒(er)童/青少年，并獲(huo)得了(le)(le)臨床默示許可。天(tian)勤(qin)生(sheng)(sheng)物子(zi)公司湖北(bei)天(tian)勤(qin)鑫(xin)(xin)圣(sheng)生(sheng)(sheng)物科技有限公司（以(yi)下稱(cheng)“天(tian)勤(qin)鑫(xin)(xin)圣(sheng)”）針對(dui)該(gai)(gai)適(shi)應(ying)癥(zheng)群體開展(zhan)了(le)(le)幼(you)齡(ling)動(dong)物非臨床毒(du)性(xing)(xing)研究(jiu)，助力其順利獲(huo)批(pi)。 兒(er)童生(sheng)(sheng)長發育(yu)的(de)(de)特殊性(xing)(xing)，對(dui)動(dong)物毒(du)性(xing)(xing)試驗(yan)(yan)(yan)研究(jiu)提出(chu)了(le)(le)更高(gao)的(de)(de)要求。天(tian)勤(qin)鑫(xin)(xin)圣(sheng)毒(du)理研究(jiu)團隊基于(yu)豐富的(de)(de)幼(you)齡(ling)動(dong)物實驗(yan)(yan)(yan)經驗(yan)(yan)(yan)，開展(zhan)了(le)(le)全面(mian)而(er)深入(ru)的(de)(de)幼(you)齡(ling)動(dong)物發育(yu)毒(du)性(xing)(xing)研究(jiu)，以(yi)人(ren)源化小鼠為(wei)(wei)試驗(yan)(yan)(yan)對(dui)象，科學設(she)計試驗(yan)(yan)(yan)方(fang)案，嚴格設(she)計試驗(yan)(yan)(yan)分組(zu)，技術操作嚴謹規范(fan)，在(zai)項目(mu)運行過程中展(zhan)現出(chu)了(le)(le)天(tian)勤(qin)鑫(xin)(xin)圣(sheng)一(yi)貫的(de)(de)技術水準和服務(wu)能力。 長期扎實的(de)(de)試驗(yan)(yan)(yan)研究(jiu)，也讓幼(you)齡(ling)動(dong)物試驗(yan)(yan)(yan)成為(wei)(wei)了(le)(le)天(tian)勤(qin)生(sheng)(sheng)物的(de)(de)王牌服務(wu)之一(yi)。截(jie)止(zhi)至今天(tian)，天(tian)勤(qin)生(sheng)(sheng)物...
- 查看詳情+
天勤生物助力寶船生物BC011抗體注射液獲批臨床
- 2024-09-13
近(jin)日，上海寶(bao)船(chuan)(chuan)生(sheng)物(wu)(wu)醫藥(yao)科技有(you)(you)限公(gong)司(si)自(zi)(zi)主研(yan)發(fa)的(de)(de)(de)(de)(de)(de)(de)(de)BC011抗體(ti)(ti)注(zhu)射(she)液(ye)成(cheng)功(gong)獲(huo)得國(guo)家藥(yao)品監(jian)督(du)管理局（NMPA）的(de)(de)(de)(de)(de)(de)(de)(de)臨(lin)床試驗(yan)(yan)批準，其適(shi)應癥為(wei)(wei)晚期實(shi)體(ti)(ti)瘤(liu)(liu)。天(tian)勤生(sheng)物(wu)(wu)武漢分公(gong)司(si)作(zuo)為(wei)(wei)寶(bao)船(chuan)(chuan)生(sheng)物(wu)(wu)的(de)(de)(de)(de)(de)(de)(de)(de)合(he)作(zuo)伙伴，為(wei)(wei)該項目提供了非臨(lin)床全(quan)套的(de)(de)(de)(de)(de)(de)(de)(de)毒理、藥(yao)代試驗(yan)(yan)服務，助力其成(cheng)功(gong)通過(guo) IND 審批進入臨(lin)床試驗(yan)(yan)階段。 BC011抗體(ti)(ti)注(zhu)射(she)液(ye)由寶(bao)船(chuan)(chuan)生(sheng)物(wu)(wu)自(zi)(zi)主研(yan)發(fa)的(de)(de)(de)(de)(de)(de)(de)(de)全(quan)人源(yuan)單克隆抗體(ti)(ti)。BC011具(ju)有(you)(you)抗體(ti)(ti)Fc端介導的(de)(de)(de)(de)(de)(de)(de)(de)ADCC作(zuo)用(yong)，可(ke)(ke)減少Treg細胞(bao)，增(zeng)(zeng)加CD8+ T細胞(bao)對(dui)腫(zhong)瘤(liu)(liu)的(de)(de)(de)(de)(de)(de)(de)(de)殺傷活(huo)性(xing)，也(ye)可(ke)(ke)直接殺傷腫(zhong)瘤(liu)(liu)細胞(bao)。體(ti)(ti)外(wai)藥(yao)效研(yan)究顯示，BC011特異性(xing)較(jiao)高(gao)，可(ke)(ke)抑制(zhi)腫(zhong)瘤(liu)(liu)細胞(bao)浸潤Treg細胞(bao) ,使腫(zhong)瘤(liu)(liu)浸潤的(de)(de)(de)(de)(de)(de)(de)(de)CTL比例(li)和(he)數(shu)量增(zeng)(zeng)加，引起(qi)CTL/Treg 的(de)(de)(de)(de)(de)(de)(de)(de)比值升(sheng)高(gao)，調節腫(zhong)瘤(liu)(liu)免疫微環(huan)境更有(you)(you)利于(yu)(yu)殺傷腫(zhong)瘤(liu)(liu)，從而展現出較(jiao)強(qiang)的(de)(de)(de)(de)(de)(de)(de)(de)抗腫(zhong)瘤(liu)(liu)活(huo)性(xing)，且安全(quan)性(xing)良好，將為(wei)(wei)腫(zhong)瘤(liu)(liu)治療提供一種全(quan)新(xin)的(de)(de)(de)(de)(de)(de)(de)(de)策略(lve)。 高(gao)效源(yuan)于(yu)(yu)協同，成(cheng)功(gong)源(yuan)于(yu)(yu)經驗(yan)(yan)。BC011抗體(ti)(ti)注(zhu)射(she)液(ye)成(cheng)功(gong)獲(huo)批臨(lin)床試驗(yan)(yan)，不僅是對(dui)寶(bao)船(chuan)(chuan)生(sheng)物(wu)(wu)自(zi)(zi)主創(chuang)新(xin)能力的(de)(de)(de)(de)(de)(de)(de)(de)肯定，也(ye)是天(tian)勤生(sheng)物(wu)(wu)臨(lin)床前(qian)研(yan)發(fa)服務平臺綜合(he)能力的(de)(de)(de)(de)(de)(de)(de)(de)見證(zheng)。天(tian)勤生(sheng)物(wu)(wu)作(zuo)為(wei)(wei)專業的(de)(de)(de)(de)(de)(de)(de)(de)一站式生(sheng)物(wu)(wu)醫藥(yao)臨(lin)床前(qian)綜合(he)研(yan)發(fa)服務CRO，多(duo)年來在創(chuang)新(xin)之(zhi)路上不斷精(jing)進，積累了眾多(duo)國(guo)內(nei)知名醫藥(yao)企業及...
- 查看詳情+
