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湖北天勤生物科技集團股份有限公司(簡稱天勤生物)成立于2009年,總部位(wei)于武漢東湖高新區光谷生物(wu)城,是一(yi)家(jia)以(yi)大動物(wu)試(shi)驗為(wei)特色、聚焦新藥研究與評(ping)價的CRO高新技術企業。服務涵蓋藥物毒性研究與安全性評價、人類疾病動物模型構建與藥效學評價、藥代動力學研究與評價、分子影像檢測與分析、生物分析、醫療器械測試非人靈(ling)長類實驗動(dong)物繁育(yu)等(deng)領域(yu),為(wei)客戶(hu)提供一站式(shi)創新藥(yao)物研發服務,以(yi)更短的實(shi)驗周期、更高質量(liang)的研究報告加快新藥(yao)上市進程。

天勤生物有(you)強大(da)的(de)項(xiang)目承(cheng)接能力,目前投入(ru)使(shi)用的(de)有(you)近3萬多平方米符合(he)GLP規范的實驗室,還有約八萬平米在建的實驗設施,可開展基于猴、犬、兔、大鼠、小鼠、豚鼠等實驗動物的試驗研究;有國際接軌(gui)的技術體系,GLP實驗室滿足國內、美國FDA、歐盟OECD、澳洲TGA等國際GLP標準,并通過國際AAALAC全面認證;有國內外知名的專家團隊,豐富的項(xiang)目經驗(yan),超千余項(xiang)專題研究、200多個新藥申(shen)報品(pin)(pin)種、超過60個中外(wai)IND申(shen)報的品(pin)(pin)種通過中國CFDA/NMPA 、美國FDA和澳(ao)大利亞TGA的審批進入臨(lin)床(chuang)。


  • 2009

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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

近日,武漢市(shi)科技創(chuang)新(xin)(xin)局發(fa)(fa)布"2025年(nian)度首(shou)批(pi)研(yan)(yan)(yan)發(fa)(fa)型(xing)企(qi)(qi)業(ye)擬入(ru)(ru)庫名(ming)(ming)單",天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)憑借自主創(chuang)新(xin)(xin)能力(li)和產業(ye)化轉(zhuan)化效率成(cheng)(cheng)(cheng)功(gong)入(ru)(ru)圍。此次(ci)遴選(xuan)聚(ju)焦新(xin)(xin)業(ye)態、新(xin)(xin)模式、新(xin)(xin)服(fu)務、新(xin)(xin)技術(shu)"四新(xin)(xin)"培(pei)育目標,全市(shi)僅15家(jia)企(qi)(qi)業(ye)入(ru)(ru)選(xuan)。作為(wei)湖北(bei)省生(sheng)(sheng)物(wu)醫藥(yao)非臨床安(an)(an)全評價領域的(de)標桿企(qi)(qi)業(ye),天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)的(de)入(ru)(ru)圍標志(zhi)著其在研(yan)(yan)(yan)發(fa)(fa)深度與市(shi)場(chang)廣度雙重(zhong)維度獲得(de)權威認(ren)可,彰顯出"硬核(he)科技+商業(ye)落(luo)地"的(de)復(fu)合(he)競(jing)爭力(li)。自2009年(nian)創(chuang)立以(yi)來,天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)始(shi)終將"研(yan)(yan)(yan)發(fa)(fa)立企(qi)(qi)"作為(wei)核(he)心(xin)戰(zhan)略,構建起(qi)"基礎研(yan)(yan)(yan)究(jiu)-技術(shu)攻關(guan)-產業(ye)轉(zhuan)化"的(de)全鏈條創(chuang)新(xin)(xin)體系。研(yan)(yan)(yan)發(fa)(fa)投入(ru)(ru)連(lian)年(nian)增加,建成(cheng)(cheng)(cheng)由多名(ming)(ming)國內外(wai)頂尖專(zhuan)家(jia)組成(cheng)(cheng)(cheng)的(de)研(yan)(yan)(yan)發(fa)(fa)指導團隊,累(lei)計獲得(de)專(zhuan)利74項(xiang),在猴生(sheng)(sheng)殖與發(fa)(fa)育毒性(xing)(xing)研(yan)(yan)(yan)究(jiu)、CNS大動(dong)物(wu)藥(yao)效學研(yan)(yan)(yan)究(jiu),毒性(xing)(xing)病理(li)(li)等(deng)領域形成(cheng)(cheng)(cheng)了關(guan)鍵技術(shu)儲備,可開展GLP條件下的(de)小分(fen)子、大分(fen)子、ADC、細胞和基因治療、兒科藥(yao)、中藥(yao)等(deng)藥(yao)物(wu)的(de)安(an)(an)全性(xing)(xing)評價、藥(yao)代動(dong)力(li)學研(yan)(yan)(yan)究(jiu)、生(sheng)(sheng)物(wu)檢(jian)測與毒性(xing)(xing)病理(li)(li)診斷分(fen)析等(deng)專(zhuan)業(ye)化的(de)CRO服(fu)務,已成(cheng)(cheng)(cheng)功(gong)助力(li)海內外(wai)多個創(chuang)新(xin)(xin)藥(yao)獲得(de)臨床批(pi)件。此次(ci)入(ru)(ru)圍武漢市(shi)首(shou)批(pi)研(yan)(yan)(yan)發(fa)(fa)型(xing)企(qi)(qi)業(ye)入(ru)(ru)庫名(ming)(ming)單,也是對(dui)天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)十五年(nian)來創(chuang)新(xin)(xin)實力(li)的(de)認(ren)證。天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)將以(yi)此次(ci)入(ru)(ru)選(xuan)為(wei)契機(ji),深化"產學研(yan)(yan)(yan)"協同創(chuang)新(xin)(xin)機(ji)制,加速(su)搭建藥(yao)物(wu)研(yan)(yan)(yan)發(fa)(fa)全周期技術(shu)服(fu)務平臺。...

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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

2025年3月16日(ri)至20日(ri),第64屆美國(guo)毒(du)理(li)學會(hui)(SOT)年會(hui)在美國(guo)奧蘭(lan)多(duo)(duo)順(shun)利召開。天(tian)勤(qin)(qin)生(sheng)物團(tuan)隊攜多(duo)(duo)項(xiang)研究(jiu)(jiu)成果參會(hui),通過壁(bi)(bi)報(bao)展示、技術(shu)研討及行(xing)業交流,與(yu)國(guo)際同行(xing)分享(xiang)毒(du)理(li)學領域的(de)研究(jiu)(jiu)成果,進一步(bu)提(ti)升了(le)(le)天(tian)勤(qin)(qin)生(sheng)物在國(guo)際毒(du)理(li)學界的(de)參與(yu)度。會(hui)議期間,天(tian)勤(qin)(qin)生(sheng)物以(yi)三組專題壁(bi)(bi)報(bao)呈現(xian)了(le)(le)其(qi)在藥(yao)物安全性(xing)評(ping)(ping)價(jia)領域的(de)研究(jiu)(jiu)進展。食蟹猴生(sheng)殖與(yu)發育(yu)毒(du)性(xing)評(ping)(ping)價(jia)體(ti)系的(de)驗證(zheng)(zheng)和優化(hua)《Validation Study on Non-clinical Reproductive and Developmental Toxicity Evaluation System in Cynomolgus Monkeys》總(zong)結(jie)了(le)(le)天(tian)勤(qin)(qin)生(sheng)物在食蟹猴生(sheng)殖與(yu)發育(yu)毒(du)性(xing)研究(jiu)(jiu)中所(suo)建立的(de)整套驗證(zheng)(zheng)和評(ping)(ping)價(jia)系統,按照ICHS5(R3)指導原則的(de)要求,通過對兩種致畸陽性(xing)藥(yao)物的(de)評(ping)(ping)價(jia)驗證(zheng)(zheng)體(ti)系的(de)研究(jiu)(jiu),建立了(le)(le)食蟹猴EFD和ePPND的(de)背景(jing)數(shu)據、試驗體(ti)系等(deng),并采用(yong)電子化(hua)數(shu)據采集(ji),為目前正在開展的(de)幾(ji)項(xiang)正式(shi)注冊申(shen)報(bao)的(de)ePPND試驗提(ti)供了(le)(le)大量基礎背景(jing)資料。抗(kang)體(ti)藥(yao)物在兔圍產(chan)期生(sheng)殖與(yu)發育(yu)毒(du)性(xing)中的(de)研究(jiu)(jiu)《Study on the Perinatal Developmental ...

天勤生物攜手耀海生物達成戰略合作

2025-03

近日(ri),湖北天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)科技(ji)(ji)集團股(gu)份(fen)有(you)限(xian)公(gong)司(以下簡(jian)(jian)稱"天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)")與(yu)江蘇耀海(hai)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)制藥(yao)(yao)有(you)限(xian)公(gong)司(以下簡(jian)(jian)稱"耀海(hai)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)")正式達成戰略(lve)合(he)(he)(he)作(zuo)(zuo)。此(ci)(ci)次(ci)合(he)(he)(he)作(zuo)(zuo)依(yi)托武(wu)創(chuang)(chuang)(chuang)(chuang)院(yuan)/天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)創(chuang)(chuang)(chuang)(chuang)新(xin)藥(yao)(yao)物(wu)(wu)(wu)發(fa)(fa)(fa)現(xian)與(yu)非臨(lin)床評(ping)價服務(wu)平(ping)(ping)臺(tai),整(zheng)合(he)(he)(he)雙(shuang)方(fang)(fang)優(you)勢資(zi)源,致力(li)于為生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)醫藥(yao)(yao)產業(ye)提供覆蓋研(yan)發(fa)(fa)(fa)全周(zhou)期的(de)(de)(de)(de)(de)一(yi)(yi)站(zhan)式創(chuang)(chuang)(chuang)(chuang)新(xin)服務(wu)。 作(zuo)(zuo)為此(ci)(ci)次(ci)合(he)(he)(he)作(zuo)(zuo)的(de)(de)(de)(de)(de)核心(xin)支撐,武(wu)創(chuang)(chuang)(chuang)(chuang)院(yuan)/天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)創(chuang)(chuang)(chuang)(chuang)新(xin)藥(yao)(yao)物(wu)(wu)(wu)發(fa)(fa)(fa)現(xian)與(yu)非臨(lin)床評(ping)價服務(wu)平(ping)(ping)臺(tai)憑借其在(zai)(zai)藥(yao)(yao)代(dai)動(dong)力(li)學、藥(yao)(yao)效(xiao)學、生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)檢(jian)測及(ji)藥(yao)(yao)物(wu)(wu)(wu)毒理與(yu)安全性評(ping)價等領(ling)(ling)域的(de)(de)(de)(de)(de)專業(ye)能力(li),為雙(shuang)方(fang)(fang)技(ji)(ji)術協(xie)同(tong)(tong)注入(ru)強(qiang)勁動(dong)能。基(ji)于此(ci)(ci),耀海(hai)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)將充分發(fa)(fa)(fa)揮(hui)其在(zai)(zai)重組蛋白/多肽、核酸(suan)藥(yao)(yao)物(wu)(wu)(wu)、納米(mi)抗體(ti)等前沿領(ling)(ling)域的(de)(de)(de)(de)(de)技(ji)(ji)術優(you)勢,結合(he)(he)(he)天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)在(zai)(zai)GLP實(shi)驗(yan)室建(jian)設(she)及(ji)臨(lin)床前研(yan)究方(fang)(fang)面的(de)(de)(de)(de)(de)經(jing)驗(yan)積累,共(gong)同(tong)(tong)構建(jian)高(gao)質(zhi)高(gao)效(xiao)的(de)(de)(de)(de)(de)研(yan)發(fa)(fa)(fa)服務(wu)體(ti)系。 通過(guo)深(shen)度合(he)(he)(he)作(zuo)(zuo),雙(shuang)方(fang)(fang)將重點(dian)優(you)化(hua)(hua)藥(yao)(yao)物(wu)(wu)(wu)研(yan)發(fa)(fa)(fa)流程,助力(li)企(qi)業(ye)縮短研(yan)發(fa)(fa)(fa)周(zhou)期、降(jiang)低綜合(he)(he)(he)成本,同(tong)(tong)時強(qiang)化(hua)(hua)研(yan)發(fa)(fa)(fa)數(shu)據的(de)(de)(de)(de)(de)合(he)(he)(he)規性與(yu)可靠性。天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)符合(he)(he)(he)國際標準的(de)(de)(de)(de)(de)試驗(yan)平(ping)(ping)臺(tai)將為項目提供技(ji)(ji)術保(bao)障(zhang),而(er)耀海(hai)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)領(ling)(ling)先的(de)(de)(de)(de)(de)微生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)表達系統技(ji)(ji)術則進一(yi)(yi)步(bu)提升了(le)(le)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)藥(yao)(yao)物(wu)(wu)(wu)的(de)(de)(de)(de)(de)研(yan)發(fa)(fa)(fa)效(xiao)率與(yu)質(zhi)量穩定性。 此(ci)(ci)次(ci)戰略(lve)合(he)(he)(he)作(zuo)(zuo)是生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)醫藥(yao)(yao)領(ling)(ling)域產學研(yan)協(xie)同(tong)(tong)創(chuang)(chuang)(chuang)(chuang)新(xin)的(de)(de)(de)(de)(de)典范,凸顯了(le)(le)武(wu)創(chuang)(chuang)(chuang)(chuang)院(yuan)/天(tian)勤(qin)(qin)生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)創(chuang)(chuang)(chuang)(chuang)新(xin)藥(yao)(yao)物(wu)(wu)(wu)發(fa)(fa)(fa)現(xian)與(yu)非臨(lin)床...

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

2024年(nian)12月20日,天(tian)勤(qin)(qin)生(sheng)物(wu)(wu)提供(gong)非(fei)臨(lin)(lin)床(chuang)研(yan)究(jiu)(jiu)服(fu)務支持的(de)甫(fu)康藥(yao)(yao)(yao)(yao)業的(de)CVL006注(zhu)(zhu)射液(ye),在(zai)晚期實體瘤患者中(zhong)(zhong)的(de)安(an)全(quan)性(xing)(xing)、耐(nai)受性(xing)(xing)、藥(yao)(yao)(yao)(yao)代(dai)動力學(xue)和(he)(he)療效的(de)開放、多(duo)中(zhong)(zhong)心的(de)I期臨(lin)(lin)床(chuang)研(yan)究(jiu)(jiu)在(zai)上海高(gao)博腫(zhong)瘤醫院和(he)(he)中(zhong)(zhong)國醫學(xue)科學(xue)院腫(zhong)瘤醫院啟動患者招募。CVL006注(zhu)(zhu)射液(ye)從2024年(nian)Q1在(zai)天(tian)勤(qin)(qin)生(sheng)物(wu)(wu)啟動研(yan)究(jiu)(jiu)至獲批(pi)臨(lin)(lin)床(chuang)僅(jin)僅(jin)10個(ge)(ge)月時間(jian),天(tian)勤(qin)(qin)生(sheng)物(wu)(wu)武漢分(fen)公司提供(gong)了(le)包括全(quan)套毒(du)理研(yan)究(jiu)(jiu)、藥(yao)(yao)(yao)(yao)代(dai)動力學(xue)研(yan)究(jiu)(jiu)和(he)(he)組織交叉反應試驗(TCR)等(deng)全(quan)套的(de)非(fei)臨(lin)(lin)床(chuang)研(yan)究(jiu)(jiu)服(fu)務工作,為CVL006注(zhu)(zhu)射液(ye)的(de)快(kuai)速(su)獲批(pi)提供(gong)了(le)專業保(bao)障。 天(tian)勤(qin)(qin)生(sheng)物(wu)(wu)武漢分(fen)公司以科學(xue)嚴謹的(de)服(fu)務支持了(le)多(duo)個(ge)(ge)抗(kang)體類藥(yao)(yao)(yao)(yao)物(wu)(wu)的(de)安(an)全(quan)性(xing)(xing)評價(jia),高(gao)質高(gao)效完成了(le)其(qi)非(fei)臨(lin)(lin)床(chuang)藥(yao)(yao)(yao)(yao)代(dai)動力學(xue)和(he)(he)安(an)全(quan)性(xing)(xing)評價(jia)研(yan)究(jiu)(jiu)。本次(ci)CVL006注(zhu)(zhu)射液(ye)項(xiang)目的(de)圓滿快(kuai)速(su)的(de)交付(fu)也再次(ci)體現了(le)天(tian)勤(qin)(qin)生(sheng)物(wu)(wu)在(zai)抗(kang)體藥(yao)(yao)(yao)(yao)物(wu)(wu)非(fei)臨(lin)(lin)床(chuang)安(an)全(quan)研(yan)究(jiu)(jiu)領域(yu)的(de)強(qiang)大的(de)項(xiang)目承(cheng)接能(neng)力。目前,天(tian)勤(qin)(qin)生(sheng)物(wu)(wu)已累計完成多(duo)個(ge)(ge)抗(kang)體類藥(yao)(yao)(yao)(yao)物(wu)(wu)安(an)全(quan)性(xing)(xing)評價(jia)項(xiang)目,包括單抗(kang)、雙抗(kang)、多(duo)抗(kang)、ADC等(deng),覆蓋腫(zhong)瘤、感染性(xing)(xing)疾病、代(dai)謝、免疫等(deng)多(duo)個(ge)(ge)疾病領域(yu)。

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

近(jin)日,天(tian)(tian)勤生(sheng)物(wu)(wu)武漢(han)分(fen)(fen)(fen)公(gong)司(si)(si)在中(zhong)國食品(pin)藥品(pin)檢(jian)定研究院組織的(de)(de)多(duo)項(xiang)(xiang)年度能力(li)(li)驗(yan)(yan)(yan)證(zheng)項(xiang)(xiang)目(mu)中(zhong)表現優異(yi)。涉及毒(du)(du)性病(bing)(bing)(bing)理(li)(li)、臨(lin)床(chuang)(chuang)(chuang)檢(jian)驗(yan)(yan)(yan)和(he)(he)生(sheng)物(wu)(wu)分(fen)(fen)(fen)析的(de)(de)多(duo)個檢(jian)測領(ling)(ling)域,且參加的(de)(de)7個項(xiang)(xiang)目(mu)均以該項(xiang)(xiang)目(mu)最(zui)(zui)高(gao)評價(jia)(jia)等(deng)級(ji)通(tong)過。1.毒(du)(du)性病(bing)(bing)(bing)理(li)(li)在毒(du)(du)性病(bing)(bing)(bing)理(li)(li)形態學(xue)(xue)檢(jian)查能力(li)(li)驗(yan)(yan)(yan)證(zheng)(NIFDC-PT-478)檢(jian)查的(de)(de)過程中(zhong),天(tian)(tian)勤生(sheng)物(wu)(wu)武漢(han)分(fen)(fen)(fen)公(gong)司(si)(si)多(duo)名(ming)具有豐富(fu)實驗(yan)(yan)(yan)動物(wu)(wu)毒(du)(du)性病(bing)(bing)(bing)理(li)(li)診斷經驗(yan)(yan)(yan)的(de)(de)研究人(ren)員嚴格遵(zun)循國際標準(zhun)操作規(gui)程,確(que)保毒(du)(du)性病(bing)(bing)(bing)理(li)(li)形態得(de)到了(le)(le)最(zui)(zui)準(zhun)確(que)、最(zui)(zui)可靠的(de)(de)解(jie)讀(du),使得(de)該項(xiang)(xiang)目(mu)評分(fen)(fen)(fen)名(ming)列前茅(mao),并(bing)以最(zui)(zui)高(gao)評價(jia)(jia)等(deng)級(ji)“優秀(xiu)”順利通(tong)過。天(tian)(tian)勤生(sheng)物(wu)(wu)武漢(han)分(fen)(fen)(fen)公(gong)司(si)(si)能夠從92家參評機構中(zhong)脫穎而出,獲得(de)“優秀(xiu)”評價(jia)(jia),充分(fen)(fen)(fen)體現了(le)(le)公(gong)司(si)(si)在病(bing)(bing)(bing)理(li)(li)學(xue)(xue)研究領(ling)(ling)域的(de)(de)技術(shu)實力(li)(li)和(he)(he)服務質(zhi)量(liang)。2.臨(lin)床(chuang)(chuang)(chuang)檢(jian)驗(yan)(yan)(yan)在血(xue)清中(zhong)生(sheng)化指(zhi)標(NIFDC-PT-509)、血(xue)液學(xue)(xue)指(zhi)標(NIFDC-PT-475)、血(xue)凝學(xue)(xue)指(zhi)標(NIFDC-PT-476)和(he)(he)尿生(sheng)化指(zhi)標(NIFDC-PT-477)四(si)個關鍵項(xiang)(xiang)目(mu)的(de)(de)能力(li)(li)驗(yan)(yan)(yan)證(zheng)過程中(zhong),天(tian)(tian)勤生(sheng)物(wu)(wu)武漢(han)分(fen)(fen)(fen)公(gong)司(si)(si)提交了(le)(le)全部37個能力(li)(li)驗(yan)(yan)(yan)證(zheng)指(zhi)標,且所有項(xiang)(xiang)目(mu)均以滿(man)分(fen)(fen)(fen)100分(fen)(fen)(fen)通(tong)過,最(zui)(zui)終獲得(de)“滿(man)意”的(de)(de)最(zui)(zui)高(gao)等(deng)級(ji)認定。在臨(lin)床(chuang)(chuang)(chuang)檢(jian)驗(yan)(yan)(yan)領(ling)(ling)域,天(tian)(tian)勤生(sheng)物(wu)(wu)武漢(han)公(gong)司(si)(si)不僅(jin)配備了(le)(le)先進(jin)的(de)(de)儀(yi)器設(she)備,還建(jian)立了(le)(le)完善的(de)(de)實驗(yan)(yan)(yan)室質(zhi)量(liang)控制體系(xi),并(bing)擁有一支高(gao)...

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

近日,正大(da)天(tian)(tian)晴(qing)(qing)藥(yao)業(ye)集團(tuan)股份有(you)限公(gong)司(si)(簡(jian)稱“正大(da)天(tian)(tian)晴(qing)(qing)”)自(zi)(zi)主研發的(de)1類新藥(yao)——BCL-2抑(yi)制劑(ji)TQB3909片,獲(huo)批了(le)更(geng)長周期(qi)臨(lin)床(chuang)試驗(yan)許(xu)可。天(tian)(tian)勤(qin)生(sheng)物(wu)(wu)子公(gong)司(si)湖北天(tian)(tian)勤(qin)鑫(xin)圣生(sheng)物(wu)(wu)科技有(you)限公(gong)司(si)(以下簡(jian)稱“天(tian)(tian)勤(qin)鑫(xin)圣”)為TQB3909的(de)臨(lin)床(chuang)前研發提供了(le)關(guan)鍵的(de)長周期(qi)毒理試驗(yan)服務,助力其成(cheng)功(gong)獲(huo)批臨(lin)床(chuang)。TQB3909是正大(da)天(tian)(tian)晴(qing)(qing)自(zi)(zi)主研發的(de)一款BCL-2抑(yi)制劑(ji),擬聯合(he)(he)化療用于急性(xing)(xing)淋(lin)巴細(xi)胞白(bai)血病(ALL)患(huan)者的(de)治療。BCL-2家族蛋白(bai)可以通(tong)過(guo)(guo)(guo)阻止線粒體(ti)外(wai)膜通(tong)透(tou)化(MOMP)從而(er)抑(yi)制腫瘤細(xi)胞凋亡,其過(guo)(guo)(guo)表達與(yu)癌(ai)癥的(de)耐(nai)藥(yao)性(xing)(xing)的(de)形成(cheng)密(mi)切(qie)相關(guan)。通(tong)過(guo)(guo)(guo)抑(yi)制BCL-2與(yu)促凋亡蛋白(bai)(如BAK)的(de)結合(he)(he),抑(yi)制BCL-2依(yi)賴性(xing)(xing)腫瘤的(de)生(sheng)長,從而(er)發揮抗腫瘤的(de)作用。自(zi)(zi)合(he)(he)作項目立(li)項之初,天(tian)(tian)勤(qin)鑫(xin)圣專(zhuan)家技術團(tuan)隊與(yu)正大(da)天(tian)(tian)晴(qing)(qing)研發團(tuan)隊精(jing)誠合(he)(he)作,根(gen)據TQB3909特點及(ji)申報(bao)要(yao)求,科學合(he)(he)理地(di)設(she)計了(le)試驗(yan)劑(ji)量(liang),嚴控試驗(yan)風險(xian)點,最(zui)終在GLP 的(de)實驗(yan)室環境和操作規范(fan)下,高質、高效地(di)完成(cheng)了(le)TQB3909的(de)3個(ge)月鼠加犬長周期(qi)給藥(yao)毒性(xing)(xing)試驗(yan),加速了(le)新藥(yao)研發進(jin)程,為TQB3909獲(huo)批臨(lin)床(chuang)提供了(le)專(zhuan)業(ye)保(bao)障。此次(ci)TQB3909獲(huo)批臨(lin)床(chuang),既顯示了(le)正大(da)天(tian)(tian)晴(qing)(qing)在抗腫瘤藥(yao)物(wu)(wu)自(zi)(zi)主研發領域的(de)創新...

獲優秀結果!天勤鑫圣再創佳績

2024-11

毒(du)性(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)形(xing)(xing)態(tai)(tai)學(xue)(xue)(xue)(xue)檢(jian)查是(shi)藥(yao)物(wu)(wu)(wu)臨床前毒(du)理(li)(li)(li)(li)學(xue)(xue)(xue)(xue)評價的(de)重(zhong)要環節。為在毒(du)性(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)診(zhen)(zhen)(zhen)斷領(ling)域持(chi)續保持(chi)高水平(ping),天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)生物(wu)(wu)(wu)子公司湖北天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)鑫(xin)圣生物(wu)(wu)(wu)科(ke)技(ji)有(you)限公司(以下稱(cheng)“天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)鑫(xin)圣”)參(can)加(jia)了(le)由中國食品藥(yao)品檢(jian)定研(yan)究院組織的(de)2024年度毒(du)性(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)形(xing)(xing)態(tai)(tai)學(xue)(xue)(xue)(xue)檢(jian)查能(neng)力(li)(li)驗(yan)證項目(NIFDC-PT-478),最終(zhong)(zhong)結(jie)果為“優秀”。本次能(neng)力(li)(li)驗(yan)證項目共準(zhun)備了(le)A、 B、 C 三套(tao)案(an)例(li),每套(tao)案(an)例(li)含 10 個(ge)(ge)病(bing)(bing)(bing)例(li),均(jun)包(bao)含腫(zhong)瘤(liu)(liu)(liu)性(xing)病(bing)(bing)(bing)變(bian) 4 例(li)和(he)非腫(zhong)瘤(liu)(liu)(liu)性(xing)病(bing)(bing)(bing)變(bian) 6 例(li),天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)鑫(xin)圣(實驗(yan)室代碼468)在本次能(neng)力(li)(li)驗(yan)證項目中分(fen)(fen)配到A套(tao)案(an)例(li)。收到病(bing)(bing)(bing)例(li)全切片(pian)圖像后(hou),天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)鑫(xin)圣快速組織病(bing)(bing)(bing)理(li)(li)(li)(li)研(yan)究部的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)診(zhen)(zhen)(zhen)斷人(ren)員,在短時間內完(wan)成了(le)10個(ge)(ge)病(bing)(bing)(bing)例(li)的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)形(xing)(xing)態(tai)(tai)學(xue)(xue)(xue)(xue)檢(jian)查并提交結(jie)果,最終(zhong)(zhong),4 個(ge)(ge)腫(zhong)瘤(liu)(liu)(liu)性(xing)病(bing)(bing)(bing)例(li)和(he)6個(ge)(ge)非腫(zhong)瘤(liu)(liu)(liu)性(xing)病(bing)(bing)(bing)例(li)的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)診(zhen)(zhen)(zhen)斷結(jie)果均(jun)獲得遠超于(yu)平(ping)均(jun)分(fen)(fen)的(de)優異成績,并以總分(fen)(fen)91.75分(fen)(fen)的(de)成績在全部92家參(can)評機構中位列(lie)第四(si)。本次能(neng)力(li)(li)驗(yan)證項目的(de)結(jie)果表明,天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)鑫(xin)圣能(neng)夠準(zhun)確使(shi)用病(bing)(bing)(bing)理(li)(li)(li)(li)學(xue)(xue)(xue)(xue)專業術語對組織病(bing)(bing)(bing)理(li)(li)(li)(li)學(xue)(xue)(xue)(xue)診(zhen)(zhen)(zhen)斷、診(zhen)(zhen)(zhen)斷要點描(miao)述、相(xiang)關病(bing)(bing)(bing)理(li)(li)(li)(li)機制和(he)其(qi)他(ta)病(bing)(bing)(bing)變(bian)描(miao)述四(si)個(ge)(ge)方面進行毒(du)性(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)形(xing)(xing)態(tai)(tai)學(xue)(xue)(xue)(xue)檢(jian)查,并進行病(bing)(bing)(bing)變(bian)的(de)綜合闡述和(he)發病(bing)(bing)(bing)機制分(fen)(fen)析(xi)。參(can)加(jia)本次能(neng)力(li)(li)驗(yan)證項目,既體現出天(tian)(tian)(tian)(tian)勤(qin)(qin)(qin)鑫(xin)圣的(de)病(bing)(bing)(bing)理(li)(li)(li)(li)診(zhen)(zhen)(zhen)斷團隊(dui)擁有(you)較強的(de)毒(du)性(xing)病(bing)(bing)(bing)理(li)(li)(li)(li)診(zhen)(zhen)(zhen)斷和(he)分(fen)(fen)析(xi)病(bing)(bing)(bing)變(bian)...

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

重慶智翔(xiang)金泰(tai)生物(wu)(wu)(wu)制(zhi)藥股份有(you)限公(gong)司(以(yi)下稱“智翔(xiang)金泰(tai)”)自主(zhu)研(yan)(yan)發的(de)GR1802注射(she)液是(shi)(shi)一(yi)款(kuan)重組全人(ren)源抗IL-4Rα單(dan)克隆抗體(ti),能(neng)特(te)異性(xing)(xing)結合(he)(he)細胞表面人(ren)IL-4Rα,阻斷IL-4、IL-13與IL-4Rα的(de)結合(he)(he),抑(yi)制(zhi)下游STAT6磷酸化,抑(yi)制(zhi)CD23上調,從而抑(yi)制(zhi)由IL-4或IL-13介導的(de)Th2型炎癥(zheng)(zheng)反(fan)應(ying)。該(gai)(gai)產(chan)品擬用(yong)于具IL-4、IL-13過表達的(de)自身免疫性(xing)(xing)疾病的(de)治(zhi)療。 特(te)應(ying)性(xing)(xing)皮炎是(shi)(shi)GR1802注射(she)液的(de)適(shi)應(ying)癥(zheng)(zheng)之一(yi)。近日,該(gai)(gai)適(shi)應(ying)癥(zheng)(zheng)將適(shi)應(ying)人(ren)群范(fan)圍擴增至兒童(tong)/青少年,并獲得了(le)臨(lin)床默示許可。天(tian)(tian)(tian)勤生物(wu)(wu)(wu)子(zi)公(gong)司湖北(bei)天(tian)(tian)(tian)勤鑫圣(sheng)(sheng)生物(wu)(wu)(wu)科(ke)技(ji)有(you)限公(gong)司(以(yi)下稱“天(tian)(tian)(tian)勤鑫圣(sheng)(sheng)”)針(zhen)對(dui)該(gai)(gai)適(shi)應(ying)癥(zheng)(zheng)群體(ti)開展了(le)幼(you)齡動(dong)物(wu)(wu)(wu)非(fei)臨(lin)床毒性(xing)(xing)研(yan)(yan)究(jiu),助力其順(shun)利獲批(pi)。 兒童(tong)生長(chang)發育(yu)的(de)特(te)殊性(xing)(xing),對(dui)動(dong)物(wu)(wu)(wu)毒性(xing)(xing)試(shi)驗(yan)研(yan)(yan)究(jiu)提出了(le)更(geng)高的(de)要求。天(tian)(tian)(tian)勤鑫圣(sheng)(sheng)毒理研(yan)(yan)究(jiu)團隊基于豐富的(de)幼(you)齡動(dong)物(wu)(wu)(wu)實(shi)(shi)驗(yan)經(jing)驗(yan),開展了(le)全面而深入的(de)幼(you)齡動(dong)物(wu)(wu)(wu)發育(yu)毒性(xing)(xing)研(yan)(yan)究(jiu),以(yi)人(ren)源化小鼠(shu)為(wei)試(shi)驗(yan)對(dui)象,科(ke)學設(she)計試(shi)驗(yan)方案,嚴格(ge)設(she)計試(shi)驗(yan)分組,技(ji)術操(cao)作嚴謹規范(fan),在項目運行過程中展現出了(le)天(tian)(tian)(tian)勤鑫圣(sheng)(sheng)一(yi)貫的(de)技(ji)術水準和服務能(neng)力。 長(chang)期扎實(shi)(shi)的(de)試(shi)驗(yan)研(yan)(yan)究(jiu),也(ye)讓(rang)幼(you)齡動(dong)物(wu)(wu)(wu)試(shi)驗(yan)成為(wei)了(le)天(tian)(tian)(tian)勤生物(wu)(wu)(wu)的(de)王牌(pai)服務之一(yi)。截止(zhi)至今天(tian)(tian)(tian),天(tian)(tian)(tian)勤生物(wu)(wu)(wu)...

天勤生物助力寶船生物BC011抗體注射液獲批臨床

2024-09

近日,上(shang)海寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)醫藥(yao)科技有(you)限(xian)公(gong)司自主(zhu)(zhu)(zhu)研發(fa)的(de)(de)(de)BC011抗(kang)體(ti)注(zhu)(zhu)射液(ye)成(cheng)功獲得國家藥(yao)品監督管理局(NMPA)的(de)(de)(de)臨(lin)(lin)床(chuang)(chuang)(chuang)試驗(yan)(yan)批準,其適(shi)應(ying)癥為(wei)晚期實體(ti)瘤(liu)(liu)(liu)(liu)。天勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)武漢分公(gong)司作(zuo)為(wei)寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)的(de)(de)(de)合(he)作(zuo)伙伴(ban),為(wei)該(gai)項目(mu)提供(gong)了非臨(lin)(lin)床(chuang)(chuang)(chuang)全套的(de)(de)(de)毒理、藥(yao)代試驗(yan)(yan)服(fu)(fu)務(wu),助(zhu)力(li)其成(cheng)功通過 IND 審批進入臨(lin)(lin)床(chuang)(chuang)(chuang)試驗(yan)(yan)階段。 BC011抗(kang)體(ti)注(zhu)(zhu)射液(ye)由寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)自主(zhu)(zhu)(zhu)研發(fa)的(de)(de)(de)全人(ren)源(yuan)單克(ke)隆抗(kang)體(ti)。BC011具有(you)抗(kang)體(ti)Fc端介導的(de)(de)(de)ADCC作(zuo)用,可減少Treg細(xi)胞(bao),增(zeng)(zeng)加CD8+ T細(xi)胞(bao)對(dui)腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)的(de)(de)(de)殺(sha)傷活性,也(ye)可直接殺(sha)傷腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)細(xi)胞(bao)。體(ti)外藥(yao)效(xiao)研究顯示,BC011特異性較高(gao),可抑制腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)細(xi)胞(bao)浸潤Treg細(xi)胞(bao) ,使腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)浸潤的(de)(de)(de)CTL比例(li)和數量增(zeng)(zeng)加,引起CTL/Treg 的(de)(de)(de)比值(zhi)升高(gao),調節腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)免疫微環境更有(you)利于(yu)(yu)殺(sha)傷腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu),從而展(zhan)現出(chu)較強的(de)(de)(de)抗(kang)腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)活性,且(qie)安全性良(liang)好,將(jiang)為(wei)腫(zhong)(zhong)瘤(liu)(liu)(liu)(liu)治療提供(gong)一(yi)種全新的(de)(de)(de)策(ce)略。 高(gao)效(xiao)源(yuan)于(yu)(yu)協(xie)同,成(cheng)功源(yuan)于(yu)(yu)經驗(yan)(yan)。BC011抗(kang)體(ti)注(zhu)(zhu)射液(ye)成(cheng)功獲批臨(lin)(lin)床(chuang)(chuang)(chuang)試驗(yan)(yan),不(bu)僅是(shi)對(dui)寶(bao)船(chuan)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)自主(zhu)(zhu)(zhu)創(chuang)新能(neng)(neng)力(li)的(de)(de)(de)肯(ken)定,也(ye)是(shi)天勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)臨(lin)(lin)床(chuang)(chuang)(chuang)前研發(fa)服(fu)(fu)務(wu)平臺綜(zong)合(he)能(neng)(neng)力(li)的(de)(de)(de)見證。天勤(qin)(qin)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)作(zuo)為(wei)專業(ye)的(de)(de)(de)一(yi)站式(shi)生(sheng)(sheng)(sheng)物(wu)(wu)(wu)(wu)醫藥(yao)臨(lin)(lin)床(chuang)(chuang)(chuang)前綜(zong)合(he)研發(fa)服(fu)(fu)務(wu)CRO,多年來在(zai)創(chuang)新之路上(shang)不(bu)斷(duan)精進,積累了眾多國內知名醫藥(yao)企業(ye)及(ji)...

精彩回顧|九月雙會聚焦,專業實力彰顯品牌力量

2024-09

九月(yue)(yue),天勤生(sheng)(sheng)物(wu)(wu)在(zai)多個行業(ye)盛會(hui)中(zhong)閃(shan)亮(liang)登(deng)場(chang),與業(ye)界(jie)同仁共同探討了(le)(le)行業(ye)發(fa)展(zhan)的(de)(de)(de)(de)熱點話題與未來(lai)趨勢(shi),并(bing)通過(guo)分(fen)享研發(fa)經(jing)驗(yan)(yan)和展(zhan)示(shi)自(zi)身在(zai)非(fei)臨(lin)(lin)床(chuang)安(an)全性(xing)評(ping)(ping)價(jia)的(de)(de)(de)(de)專業(ye)能力,得到(dao)了(le)(le)業(ye)界(jie)的(de)(de)(de)(de)廣泛認可和高度評(ping)(ping)價(jia)。第(di)四屆上(shang)海·臨(lin)(lin)港生(sheng)(sheng)物(wu)(wu)醫藥(yao)(yao)(yao)創新發(fa)展(zhan)論壇(tan) 8月(yue)(yue)31日至9月(yue)(yue)1日,第(di)四屆上(shang)海·臨(lin)(lin)港生(sheng)(sheng)物(wu)(wu)醫藥(yao)(yao)(yao)創新發(fa)展(zhan)論壇(tan)—2024年(nian)(nian)先(xian)進(jin)治(zhi)療(liao)(liao)藥(yao)(yao)(yao)品研發(fa)主題論壇(tan)于生(sheng)(sheng)命藍(lan)灣舉行。期間,天勤生(sheng)(sheng)物(wu)(wu)執行副總裁周莉(li)研究員(yuan)以《先(xian)進(jin)治(zhi)療(liao)(liao)藥(yao)(yao)(yao)品非(fei)臨(lin)(lin)床(chuang)生(sheng)(sheng)殖與發(fa)育毒(du)(du)性(xing)評(ping)(ping)價(jia)研究策略及案例分(fen)析(xi)》為題進(jin)行了(le)(le)專題分(fen)享,周莉(li)研究員(yuan)著重介紹了(le)(le)先(xian)進(jin)藥(yao)(yao)(yao)品非(fei)臨(lin)(lin)床(chuang)生(sheng)(sheng)殖與發(fa)育毒(du)(du)性(xing)評(ping)(ping)價(jia)研究的(de)(de)(de)(de)關注重點,并(bing)通過(guo)實際案例展(zhan)示(shi)了(le)(le)天勤生(sheng)(sheng)物(wu)(wu)在(zai)先(xian)進(jin)治(zhi)療(liao)(liao)藥(yao)(yao)(yao)物(wu)(wu),特別是(shi)基(ji)因治(zhi)療(liao)(liao)、細胞(bao)治(zhi)療(liao)(liao)以及小核酸藥(yao)(yao)(yao)物(wu)(wu)在(zai)非(fei)臨(lin)(lin)床(chuang)階段進(jin)行生(sheng)(sheng)殖與發(fa)育毒(du)(du)性(xing)評(ping)(ping)價(jia)研究的(de)(de)(de)(de)項(xiang)目經(jing)驗(yan)(yan)。期間,她(ta)還特別提到(dao)了(le)(le)這些新型療(liao)(liao)法在(zai)生(sheng)(sheng)殖系統中(zhong)的(de)(de)(de)(de)分(fen)布(bu)情(qing)況、對(dui)生(sheng)(sheng)殖細胞(bao)的(de)(de)(de)(de)影響(xiang)以及潛在(zai)的(de)(de)(de)(de)遺傳風險(xian),并(bing)強調了(le)(le)根(gen)據藥(yao)(yao)(yao)物(wu)(wu)特性(xing)選(xuan)擇合適的(de)(de)(de)(de)評(ping)(ping)價(jia)模(mo)型的(de)(de)(de)(de)重要性(xing)。2024年(nian)(nian)(第(di)十二(er)(er)屆)藥(yao)(yao)(yao)物(wu)(wu)毒(du)(du)理(li)學(xue)年(nian)(nian)會(hui) 9月(yue)(yue)1日至3日,2024(第(di)十二(er)(er)屆)藥(yao)(yao)(yao)物(wu)(wu)毒(du)(du)理(li)學(xue)年(nian)(nian)會(hui)在(zai)上(shang)海市光大會(hui)展(zhan)中(zhong)心召開。天勤生(sheng)(sheng)物(wu)(wu)對(dui)本次(ci)年(nian)(nian)會(hui)高度重視,攜藥(yao)(yao)(yao)物(wu)(wu)毒(du)(du)理(li)領域(yu)的(de)(de)(de)(de)多項(xiang)研究成果在(zai)本次(ci)年(nian)(nian)會(hui)上(shang)進(jin)行了(le)(le)專題...

天勤生物助力智翔金泰的賽立奇單抗注射液獲批上市

2024-09

8月27日(ri),重慶智(zhi)翔金(jin)泰生物(wu)(wu)制藥股(gu)份有(you)限公司(si)(以下稱“智(zhi)翔金(jin)泰”)自(zi)(zi)主(zhu)研發(fa)的(de)(de)(de)1類(lei)新藥賽立(li)(li)奇單(dan)抗(kang)(kang)注射(she)液(商品(pin)名:金(jin)立(li)(li)希?)獲得國(guo)家藥品(pin)監督管理局(NMPA)核準簽發(fa)的(de)(de)(de)《藥品(pin)注冊(ce)證書》,正式獲批上(shang)(shang)市(shi)(shi)。天勤生物(wu)(wu)子公司(si)湖北(bei)天勤鑫(xin)(xin)(xin)圣(sheng)生物(wu)(wu)科技(ji)有(you)限公司(si)(以下稱“天勤鑫(xin)(xin)(xin)圣(sheng)”)為(wei)該(gai)項目提供了部(bu)分臨(lin)床前(qian)(qian)安(an)全(quan)性評價試(shi)驗服務(wu)(wu),全(quan)力(li)助推該(gai)產(chan)(chan)品(pin)順利(li)獲批上(shang)(shang)市(shi)(shi)。 賽立(li)(li)奇單(dan)抗(kang)(kang)注射(she)液擬用于中、重度斑塊(kuai)狀(zhuang)銀(yin)(yin)屑病(bing)的(de)(de)(de)治療,是(shi)智(zhi)翔金(jin)泰首(shou)款獲批上(shang)(shang)市(shi)(shi)的(de)(de)(de)產(chan)(chan)品(pin),也是(shi)國(guo)內(nei)自(zi)(zi)主(zhu)知識產(chan)(chan)權(quan)的(de)(de)(de)全(quan)人源IL-17A靶點(dian)藥物(wu)(wu)。據悉,截止至目前(qian)(qian),僅(jin)有(you)3款同靶點(dian)進(jin)口產(chan)(chan)品(pin)在國(guo)內(nei)獲批上(shang)(shang)市(shi)(shi),智(zhi)翔金(jin)泰賽立(li)(li)奇單(dan)抗(kang)(kang)注射(she)液是(shi)首(shou)批國(guo)產(chan)(chan)獲準上(shang)(shang)市(shi)(shi)的(de)(de)(de)同類(lei)品(pin)種。該(gai)產(chan)(chan)品(pin)打破了抗(kang)(kang)IL-17A單(dan)抗(kang)(kang)藥物(wu)(wu)被(bei)外資藥企壟斷的(de)(de)(de)局面,填(tian)補了國(guo)產(chan)(chan)治療銀(yin)(yin)屑病(bing)等自(zi)(zi)身免(mian)疫性疾病(bing)生物(wu)(wu)制劑領域的(de)(de)(de)空白,標(biao)志著我國(guo)在生物(wu)(wu)醫藥領域又向前(qian)(qian)邁(mai)進(jin)了一步。圍繞該(gai)產(chan)(chan)品(pin)的(de)(de)(de)部(bu)分安(an)全(quan)性評價試(shi)驗,天勤鑫(xin)(xin)(xin)圣(sheng)始(shi)終以需求為(wei)導向,精心設計試(shi)驗方案,優化(hua)試(shi)驗流程,配備優秀的(de)(de)(de)技(ji)術團隊。項目組放棄大(da)量(liang)(liang)休息時間(jian),堅(jian)守(shou)一線,加(jia)班加(jia)點(dian),確保高質量(liang)(liang)按時完成智(zhi)翔金(jin)泰委托的(de)(de)(de)試(shi)驗任務(wu)(wu)。 該(gai)產(chan)(chan)品(pin)順利(li)獲批上(shang)(shang)市(shi)(shi),不僅(jin)是(shi)天勤鑫(xin)(xin)(xin)圣(sheng)技(ji)術實力(li)成熟和(he)...

GLP現場檢查!天勤生物再次通過

2024-08

日前,國(guo)家藥(yao)品監(jian)督管(guan)(guan)理(li)(li)局(ju)對湖北天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)武漢分公(gong)司(以(yi)下稱(cheng)“天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)武漢分公(gong)司”)執(zhi)行《藥(yao)物(wu)非(fei)臨(lin)(lin)床研究(jiu)質(zhi)量(liang)管(guan)(guan)理(li)(li)規范》(以(yi)下稱(cheng)GLP)的(de)情況進(jin)行了(le)為(wei)期1周的(de)定期現場檢查(cha),結(jie)果均順利(li)通過(guo)。 為(wei)確保用藥(yao)安全(quan)(quan),GLP是藥(yao)物(wu)非(fei)臨(lin)(lin)床評價(jia)研究(jiu)必須遵循的(de)一套嚴(yan)格質(zhi)量(liang)管(guan)(guan)理(li)(li)體系。檢查(cha)組專家對天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)武漢分公(gong)司的(de)組織機構與人員、實驗(yan)設(she)(she)施(shi)與管(guan)(guan)理(li)(li)、儀器設(she)(she)備和(he)實驗(yan)材料(liao)(liao)、標(biao)(biao)準(zhun)操作規程(cheng)、資料(liao)(liao)檔(dang)案(an)五大核心模塊(kuai)進(jin)行了(le)全(quan)(quan)面檢查(cha),重點查(cha)驗(yan)了(le)非(fei)臨(lin)(lin)床研究(jiu)原始(shi)數據的(de)真實性(xing)(xing)(xing)、可(ke)靠性(xing)(xing)(xing)、可(ke)追溯性(xing)(xing)(xing),結(jie)果均符合GLP要求。這標(biao)(biao)志(zhi)著天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)質(zhi)量(liang)管(guan)(guan)理(li)(li)體系的(de)高度依從性(xing)(xing)(xing)。 自2017年開始(shi),天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)便(bian)開始(shi)參照(zhao)GLP準(zhun)則,建立評價(jia)研究(jiu)體系。作為(wei)湖北省第一家民營GLP研究(jiu)機構,也是中部地區(qu)GLP認證資質(zhi)最(zui)全(quan)(quan)的(de)機構,天(tian)(tian)勤(qin)(qin)生(sheng)(sheng)物(wu)武漢分公(gong)司擁有超(chao)過(guo)10000m2的(de)試(shi)驗(yan)設(she)(she)施(shi),滿(man)足國(guo)內、美(mei)國(guo)FDA、歐盟OECD、澳(ao)洲TGA等GLP標(biao)(biao)準(zhun),服務涵蓋單(dan)次和(he)重復給(gei)藥(yao)毒(du)性(xing)(xing)(xing)試(shi)驗(yan)(嚙齒(chi)類(lei))、單(dan)次和(he)重復給(gei)藥(yao)毒(du)性(xing)(xing)(xing)試(shi)驗(yan)(非(fei)嚙齒(chi)類(lei))、生(sheng)(sheng)殖毒(du)性(xing)(xing)(xing)試(shi)驗(yan)(I段、II段、III段)、遺傳毒(du)性(xing)(xing)(xing)試(shi)驗(yan)(Ames、微核、染色體畸變)、致癌(ai)性(xing)(xing)(xing)試(shi)驗(yan)、局(ju)部毒(du)性(xing)(xing)(xing)試(shi)驗(yan)、免疫(yi)原性(xing)(xing)(xing)試(shi)驗(yan)、安全(quan)(quan)藥(yao)理(li)(li)學試(shi)...

天勤生物與邁瑞動物醫療、和興康科技達成戰略合作

2024-08

“‘新(xin)’力共享,‘質’手并進”。8月23日,湖北天(tian)勤生物(wu)(wu)(wu)科(ke)技(ji)(ji)股(gu)份(fen)(fen)(fen)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)、深圳(zhen)(zhen)邁瑞動(dong)(dong)(dong)物(wu)(wu)(wu)醫(yi)療(liao)(liao)科(ke)技(ji)(ji)股(gu)份(fen)(fen)(fen)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)、武(wu)漢和(he)(he)興康科(ke)技(ji)(ji)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)在武(wu)漢圓滿完成(cheng)戰(zhan)略(lve)簽約。會議伊(yi)始,湖北天(tian)勤生物(wu)(wu)(wu)科(ke)技(ji)(ji)股(gu)份(fen)(fen)(fen)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)執行副總(zong)裁胡(hu)大裕(yu)、深圳(zhen)(zhen)邁瑞動(dong)(dong)(dong)物(wu)(wu)(wu)醫(yi)療(liao)(liao)科(ke)技(ji)(ji)股(gu)份(fen)(fen)(fen)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)大亞太(tai)區總(zong)經理周(zhou)游、武(wu)漢和(he)(he)興康科(ke)技(ji)(ji)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)總(zong)經理嚴敏分別致辭。胡(hu)大裕(yu)介(jie)紹,在國家創(chuang)(chuang)新(xin)驅動(dong)(dong)(dong)發(fa)展戰(zhan)略(lve)引領(ling)(ling)下,實驗(yan)動(dong)(dong)(dong)物(wu)(wu)(wu)行業正(zheng)迎來(lai)前所未有(you)(you)的發(fa)展機遇(yu)。創(chuang)(chuang)新(xin)藥物(wu)(wu)(wu)研(yan)發(fa)近年持續升(sheng)溫,實驗(yan)動(dong)(dong)(dong)物(wu)(wu)(wu)作為不可或缺的研(yan)究(jiu)對(dui)象,在藥物(wu)(wu)(wu)研(yan)發(fa)中的作用愈(yu)發(fa)重(zhong)要;寵物(wu)(wu)(wu)數量的增長(chang)(超(chao)過1億(yi)只(zhi)),也進一(yi)步帶動(dong)(dong)(dong)了市場對(dui)專業動(dong)(dong)(dong)物(wu)(wu)(wu)診(zhen)療(liao)(liao)服(fu)務(wu)及設備(bei)(bei)的需求(qiu)。他(ta)表示,天(tian)勤生物(wu)(wu)(wu)以大動(dong)(dong)(dong)物(wu)(wu)(wu)試驗(yan)為特色、聚焦新(xin)藥研(yan)究(jiu)與(yu)評價(jia),業務(wu)覆蓋(gai)領(ling)(ling)域廣泛,致力于(yu)為客戶提供一(yi)站式創(chuang)(chuang)新(xin)藥物(wu)(wu)(wu)研(yan)發(fa)服(fu)務(wu)。他(ta)強調(diao),三(san)方(fang)將在動(dong)(dong)(dong)物(wu)(wu)(wu)醫(yi)療(liao)(liao)設備(bei)(bei)的有(you)(you)效(xiao)性與(yu)安(an)全性評價(jia)、積累(lei)動(dong)(dong)(dong)物(wu)(wu)(wu)醫(yi)療(liao)(liao)相關數據、改進現有(you)(you)設備(bei)(bei)、解決(jue)使用人用設備(bei)(bei)時遇(yu)到的問題等方(fang)面(mian)開展全面(mian)合作,以市場需求(qiu)為依托,共同促進動(dong)(dong)(dong)物(wu)(wu)(wu)醫(yi)療(liao)(liao)和(he)(he)實驗(yan)動(dong)(dong)(dong)物(wu)(wu)(wu)科(ke)研(yan)行業進步。周(zhou)游介(jie)紹,邁瑞集團(tuan)專注于(yu)醫(yi)療(liao)(liao)設備(bei)(bei)的研(yan)發(fa)、生產和(he)(he)提供整體(ti)解決(jue)方(fang)案,并在2020年底成(cheng)立了深圳(zhen)(zhen)邁瑞動(dong)(dong)(dong)物(wu)(wu)(wu)醫(yi)療(liao)(liao)科(ke)技(ji)(ji)股(gu)份(fen)(fen)(fen)有(you)(you)限(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)。公(gong)(gong)(gong)(gong)司(si)(si)投入(ru)了大量科(ke)研(yan)力量發(fa)...

七月雙會齊發,展現非臨床安全性評價卓越實力

2024-08

盛夏七月,天(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)亮相多(duo)個行(xing)業(ye)會議(yi),與(yu)行(xing)業(ye)同仁共同探索生(sheng)物(wu)(wu)(wu)醫(yi)藥(yao)(yao)(yao)領(ling)(ling)域(yu)合(he)作發(fa)展(zhan)(zhan)新(xin)機(ji)遇,并通過分(fen)享研(yan)發(fa)經(jing)驗(yan)和展(zhan)(zhan)示自(zi)身在(zai)(zai)(zai)(zai)非臨床(chuang)安(an)(an)(an)全性(xing)(xing)評(ping)(ping)(ping)價(jia)的(de)(de)(de)(de)(de)專業(ye)能力,得到了業(ye)界(jie)的(de)(de)(de)(de)(de)廣(guang)泛認可和高(gao)度(du)評(ping)(ping)(ping)價(jia)。抗(kang)體&ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)開發(fa)與(yu)工(gong)藝(yi)(yi)發(fa)展(zhan)(zhan)論壇 7月18日至19日,“中國(武漢)抗(kang)體&ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)開發(fa)與(yu)工(gong)藝(yi)(yi)發(fa)展(zhan)(zhan)論壇”在(zai)(zai)(zai)(zai)武漢花山月酒店隆重召開,本次會議(yi)旨在(zai)(zai)(zai)(zai)匯(hui)聚國內外生(sheng)物(wu)(wu)(wu)制藥(yao)(yao)(yao)領(ling)(ling)域(yu)的(de)(de)(de)(de)(de)頂尖專家、學(xue)者及(ji)行(xing)業(ye)領(ling)(ling)袖,共同探討生(sheng)物(wu)(wu)(wu)藥(yao)(yao)(yao)工(gong)藝(yi)(yi)的(de)(de)(de)(de)(de)創(chuang)新(xin)發(fa)展(zhan)(zhan)、工(gong)藝(yi)(yi)深度(du)探索、分(fen)析與(yu)質量(liang)控制以(yi)及(ji)ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)非臨床(chuang)安(an)(an)(an)全性(xing)(xing)評(ping)(ping)(ping)價(jia)等(deng)前沿話題。 會議(yi)期(qi)間,天(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)執行(xing)副總(zong)裁周莉博(bo)士以(yi)“ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)非臨床(chuang)安(an)(an)(an)全性(xing)(xing)評(ping)(ping)(ping)價(jia)策(ce)略及(ji)案例分(fen)享”為(wei)題,著重介紹(shao)了ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)非臨床(chuang)安(an)(an)(an)全性(xing)(xing)評(ping)(ping)(ping)價(jia)的(de)(de)(de)(de)(de)關注重點,并通過實際案例展(zhan)(zhan)示了天(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)在(zai)(zai)(zai)(zai)ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)非臨床(chuang)安(an)(an)(an)全性(xing)(xing)評(ping)(ping)(ping)價(jia)研(yan)究中的(de)(de)(de)(de)(de)項(xiang)目經(jing)驗(yan)。ADC作為(wei)當前腫瘤治療領(ling)(ling)域(yu)極具(ju)前景(jing)的(de)(de)(de)(de)(de)賽(sai)道,是新(xin)藥(yao)(yao)(yao)開發(fa)的(de)(de)(de)(de)(de)熱點領(ling)(ling)域(yu)之一(yi),在(zai)(zai)(zai)(zai)研(yan)新(xin)藥(yao)(yao)(yao)數量(liang)也呈爆發(fa)式增長趨勢(shi)。天(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)在(zai)(zai)(zai)(zai)ADC領(ling)(ling)域(yu)深耕多(duo)年,擁有(you)經(jing)驗(yan)豐(feng)富(fu)的(de)(de)(de)(de)(de)技(ji)術團隊(dui)和科研(yan)經(jing)驗(yan),以(yi)高(gao)標準、高(gao)質量(liang)的(de)(de)(de)(de)(de)服務而廣(guang)受客戶(hu)好評(ping)(ping)(ping)!可以(yi)為(wei)客戶(hu)提(ti)供ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)偶聯、ADC藥(yao)(yao)(yao)效學(xue)評(ping)(ping)(ping)價(jia)、ADC藥(yao)(yao)(yao)代動力學(xue)評(ping)(ping)(ping)價(jia)和ADC安(an)(an)(an)全性(xing)(xing)評(ping)(ping)(ping)價(jia)等(deng)服務。第三屆(jie)...

天勤生物助力百泰生物/安博泰克JH013注射液獲批臨床

2024-08

近日,由百泰生物(wu)(wu)和(he)安博(bo)泰克(ke)藥(yao)業(ye)共同申報的(de)(de)(de)Ⅰ類新藥(yao)JH013注(zhu)射(she)液獲(huo)得國(guo)(guo)家藥(yao)品監督管理(li)局藥(yao)品審評中(zhong)(zhong)心頒發(fa)(fa)的(de)(de)(de)臨(lin)床(chuang)批(pi)件(IND),予以(yi)準許開展臨(lin)床(chuang)試驗(yan)。天(tian)勤生物(wu)(wu)武(wu)漢(han)分公司(si)受百泰生物(wu)(wu)/安博(bo)泰克(ke)委托(tuo),為該項目提(ti)供(gong)了(le)非(fei)臨(lin)床(chuang)全套的(de)(de)(de)毒理(li)、藥(yao)代和(he)組(zu)織交叉反應試驗(yan)服務,助力(li)其成(cheng)功通(tong)過(guo)(guo) IND 審批(pi)進入(ru)臨(lin)床(chuang)試驗(yan)階段。 JH013注(zhu)射(she)液是首個獲(huo)得臨(lin)床(chuang)研(yan)究批(pi)件的(de)(de)(de)國(guo)(guo)產(BAFF-R)單克(ke)隆抗體(ti)藥(yao)物(wu)(wu),擬用于治(zhi)(zhi)(zhi)療原(yuan)發(fa)(fa)性(xing)干燥(zao)綜合征(zheng)、系統(tong)性(xing)紅(hong)斑(ban)狼(lang)(lang)瘡(chuang)等自(zi)身(shen)免疫性(xing)疾病。它能夠靶向(xiang)B細胞上的(de)(de)(de)BAFF受體(ti),導(dao)致細胞裂解(jie)和(he)阻斷BAFF相關信號傳遞,有望為原(yuan)發(fa)(fa)性(xing)干燥(zao)綜合征(zheng)、系統(tong)性(xing)紅(hong)斑(ban)狼(lang)(lang)瘡(chuang)、類風濕性(xing)關節炎等B細胞過(guo)(guo)度活化的(de)(de)(de)自(zi)身(shen)免疫性(xing)疾病的(de)(de)(de)治(zhi)(zhi)(zhi)療提(ti)供(gong)新的(de)(de)(de)方案(an)。 項目推進過(guo)(guo)程中(zhong)(zhong),天(tian)勤生物(wu)(wu)武(wu)漢(han)分公司(si)遵循(xun)NMPA和(he)ICH指導(dao)原(yuan)則(ze),在符合NMPA標準的(de)(de)(de)GLP實驗(yan)室環(huan)境和(he)操(cao)作規(gui)范下,依托(tuo)豐(feng)富(fu)的(de)(de)(de)抗體(ti)藥(yao)物(wu)(wu)非(fei)臨(lin)床(chuang)評價的(de)(de)(de)項目經驗(yan),制定(ding)了(le)針對JH013注(zhu)射(she)液特點的(de)(de)(de)非(fei)臨(lin)床(chuang)評價策略(lve)和(he)方案(an),以(yi)過(guo)(guo)硬(ying)的(de)(de)(de)專業(ye)能力(li)和(he)高效的(de)(de)(de)執行力(li),為該產品順利、快速獲(huo)批(pi)臨(lin)床(chuang)提(ti)供(gong)了(le)有力(li)支撐。 此次成(cheng)功獲(huo)批(pi),不(bu)僅系統(tong)性(xing)紅(hong)斑(ban)狼(lang)(lang)瘡(chuang)患者迎來革新治(zhi)(zhi)(zhi)療方案(an)的(de)(de)(de)新曙光,天(tian)勤生物(wu)(wu)的(de)(de)(de)服...

順利通過!天勤研究院迎喜訊

2024-07

7月10-11日,天(tian)(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)(wu)全(quan)資子公司湖北(bei)天(tian)(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)(wu)技(ji)(ji)術研(yan)究(jiu)(jiu)(jiu)院(yuan)有(you)(you)限(xian)公司(以下稱“天(tian)(tian)(tian)勤(qin)研(yan)究(jiu)(jiu)(jiu)院(yuan)”)與湖北(bei)天(tian)(tian)(tian)勤(qin)鑫宸醫藥科技(ji)(ji)有(you)(you)限(xian)公司(以下稱“天(tian)(tian)(tian)勤(qin)鑫宸”)分(fen)別接受了省(sheng)科技(ji)(ji)廳專(zhuan)家(jia)(jia)一(yi)行8人的(de)雙(shuang)隨(sui)機(ji)(ji)檢(jian)查(cha)及(ji)(ji)年檢(jian),經過專(zhuan)家(jia)(jia)組(zu)三(san)個(ge)小(xiao)時的(de)實(shi)地檢(jian)查(cha)和記(ji)錄查(cha)閱,結(jie)果均獲一(yi)次(ci)性通過。 專(zhuan)家(jia)(jia)組(zu)依據(ju)國(guo)家(jia)(jia)相關(guan)標準(zhun)要(yao)求(qiu),通過審閱文件、核查(cha)資料(liao)、實(shi)地察(cha)看、提問交流(liu)等方式,對動(dong)(dong)物(wu)(wu)(wu)(wu)質量控制(zhi)、動(dong)(dong)物(wu)(wu)(wu)(wu)福(fu)利、生(sheng)物(wu)(wu)(wu)(wu)安全(quan)等方面的(de)工作給予了充分(fen)肯定(ding),一(yi)致認為天(tian)(tian)(tian)勤(qin)研(yan)究(jiu)(jiu)(jiu)院(yuan)及(ji)(ji)天(tian)(tian)(tian)勤(qin)鑫宸質量管(guan)理(li)意(yi)識強(qiang),動(dong)(dong)物(wu)(wu)(wu)(wu)飼養(yang)環境(jing)指標符合標準(zhun)要(yao)求(qiu),生(sheng)物(wu)(wu)(wu)(wu)安全(quan)及(ji)(ji)管(guan)理(li)流(liu)程(cheng)合規(gui)有(you)(you)序,各項記(ji)錄真實(shi)完整;特別是(shi)現場提問環節,專(zhuan)家(jia)(jia)組(zu)表現出極(ji)高的(de)滿意(yi)度(du)(du)。 省(sheng)科技(ji)(ji)廳陳(chen)軍云(yun)處(chu)長指出,科學研(yan)究(jiu)(jiu)(jiu)對實(shi)驗(yan)環境(jing)要(yao)求(qiu)較高,需要(yao)健全(quan)的(de)制(zhi)度(du)(du)及(ji)(ji)強(qiang)有(you)(you)力的(de)保(bao)障措施,特別是(shi)對位于中(zhong)心城(cheng)區的(de)實(shi)驗(yan)室,意(yi)味著(zhu)更大的(de)挑戰。陳(chen)處(chu)長希望(wang)天(tian)(tian)(tian)勤(qin)研(yan)究(jiu)(jiu)(jiu)院(yuan)及(ji)(ji)天(tian)(tian)(tian)勤(qin)鑫宸強(qiang)化生(sheng)物(wu)(wu)(wu)(wu)安全(quan)紅線(xian)意(yi)識,全(quan)程(cheng)對標國(guo)家(jia)(jia)要(yao)求(qiu),堅(jian)持“管(guan)理(li)制(zhi)度(du)(du)化、制(zhi)度(du)(du)流(liu)程(cheng)化”合規(gui)理(li)念,精進不怠(dai),繼(ji)續(xu)發(fa)揮(hui)行業(ye)標桿的(de)模范帶頭作用(yong)。 天(tian)(tian)(tian)勤(qin)生(sheng)物(wu)(wu)(wu)(wu)副總裁李高參加了檢(jian)查(cha)活動(dong)(dong),肯定(ding)了雙(shuang)隨(sui)機(ji)(ji)檢(jian)查(cha)及(ji)(ji)年檢(jian)對動(dong)(dong)物(wu)(wu)(wu)(wu)質量管(guan)理(li)的(de)積極(ji)提升作用(yong),并對天(tian)(tian)(tian)勤(qin)研(yan)究(jiu)(jiu)(jiu)院(yuan)及(ji)(ji)天(tian)(tian)(tian)勤(qin)鑫宸在動(dong)(dong)物(wu)(wu)(wu)(wu)...

天勤生物參加2024年生殖毒理藥理學及實驗動物與毒理學學術研討會

2024-07

7月9日-12日,由(you)湖北天(tian)(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)科(ke)(ke)技股(gu)份有(you)限公司協(xie)辦的2024年生(sheng)(sheng)(sheng)(sheng)殖(zhi)毒(du)(du)理(li)(li)藥(yao)(yao)(yao)理(li)(li)學理(li)(li)論(lun)與(yu)(yu)技術(shu)及科(ke)(ke)技產品研(yan)發學術(shu)交流大(da)(da)會(hui)(hui),暨中(zhong)國(guo)實(shi)驗(yan)動物(wu)(wu)(wu)學會(hui)(hui)實(shi)驗(yan)動物(wu)(wu)(wu)與(yu)(yu)毒(du)(du)理(li)(li)學專(zhuan)業(ye)委員(yuan)會(hui)(hui)第三(san)屆學術(shu)研(yan)討會(hui)(hui)在(zai)西安順利召開(kai)。天(tian)(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)不僅全(quan)(quan)程深入參與(yu)(yu)會(hui)(hui)議的籌備(bei)與(yu)(yu)組(zu)織,更在(zai)食蟹(xie)猴(hou)(hou)、大(da)(da)小鼠生(sheng)(sheng)(sheng)(sheng)殖(zhi)與(yu)(yu)發育毒(du)(du)性(xing)(xing)等(deng)專(zhuan)業(ye)領(ling)(ling)域亮點頻出,多(duo)維度(du)展示(shi)了(le)天(tian)(tian)勤魅力。 作為本次大(da)(da)會(hui)(hui)主席,天(tian)(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)執行(xing)副總裁周莉博(bo)士(shi)在(zai)開(kai)幕式上致辭,預祝大(da)(da)會(hui)(hui)圓(yuan)滿(man)成功。周莉博(bo)士(shi)不僅是(shi)生(sheng)(sheng)(sheng)(sheng)殖(zhi)與(yu)(yu)發育毒(du)(du)性(xing)(xing)領(ling)(ling)域的專(zhuan)家,行(xing)業(ye)影響力顯著(zhu),也是(shi)天(tian)(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)的一張(zhang)靚(jing)麗名(ming)(ming)片。周莉博(bo)士(shi)帶領(ling)(ling)團(tuan)隊多(duo)次攻堅,協(xie)助(zhu)客戶的各(ge)類(lei)單(dan)抗(kang)(kang)(kang)、雙抗(kang)(kang)(kang)、多(duo)抗(kang)(kang)(kang)、多(duo)肽、干細(xi)胞、mRNA預防性(xing)(xing)和治療性(xing)(xing)疫苗、ADC藥(yao)(yao)(yao)物(wu)(wu)(wu)、細(xi)胞因子(zi)、化藥(yao)(yao)(yao)、經典名(ming)(ming)方、中(zhong)藥(yao)(yao)(yao)復方制(zhi)劑(ji)等(deng)項(xiang)目高效(xiao)獲批。特別是(shi)牽頭(tou)搭建了(le)國(guo)內(nei)領(ling)(ling)先的食蟹(xie)猴(hou)(hou)生(sheng)(sheng)(sheng)(sheng)殖(zhi)毒(du)(du)性(xing)(xing)與(yu)(yu)發育毒(du)(du)性(xing)(xing)研(yan)究平(ping)臺。該平(ping)臺也是(shi)國(guo)家科(ke)(ke)技部重大(da)(da)新藥(yao)(yao)(yao)創制(zhi)科(ke)(ke)技重大(da)(da)專(zhuan)項(xiang)的藥(yao)(yao)(yao)物(wu)(wu)(wu)安全(quan)(quan)性(xing)(xing)評價(jia)示(shi)范平(ping)臺之一。會(hui)(hui)議期間,周莉博(bo)士(shi)以“食蟹(xie)猴(hou)(hou)生(sheng)(sheng)(sheng)(sheng)殖(zhi)與(yu)(yu)發育毒(du)(du)性(xing)(xing)評價(jia)策略和案例分享”為題,著(zhu)重介紹了(le)天(tian)(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)在(zai)食蟹(xie)猴(hou)(hou)非臨床生(sheng)(sheng)(sheng)(sheng)殖(zhi)與(yu)(yu)發育毒(du)(du)性(xing)(xing)領(ling)(ling)域所建立的完整體(ti)系,并展示(shi)了(le)天(tian)(tian)勤生(sheng)(sheng)(sheng)(sheng)物(wu)(wu)(wu)的實(shi)驗(yan)室背(bei)景(jing)數據、孕猴(hou)(hou)和仔猴(hou)(hou)生(sheng)(sheng)(sheng)(sheng)殖(zhi)與(yu)(yu)發育毒(du)(du)性(xing)(xing)的試驗(yan)數據以及某單(dan)抗(kang)(kang)(kang)透過血睪屏障、...

強強聯合 | 天勤生物與中科院武漢植物園達成戰略合作

2024-07

為發揮各自優勢(shi),加速科(ke)(ke)研(yan)成果落地(di),深化協(xie)(xie)同(tong)育(yu)人(ren),7月(yue)9日,中國(guo)科(ke)(ke)學院(yuan)武(wu)漢(han)(han)植(zhi)(zhi)物(wu)(wu)(wu)(wu)園(yuan)(yuan)·湖北天(tian)(tian)(tian)勤(qin)生物(wu)(wu)(wu)(wu)科(ke)(ke)技股份有(you)(you)限公司共同(tong)簽署戰略(lve)合(he)(he)(he)作(zuo)框架協(xie)(xie)議,締結全(quan)面(mian)戰略(lve)合(he)(he)(he)作(zuo)伙伴關系(xi),協(xie)(xie)力(li)(li)(li)共創(chuang)(chuang)藥物(wu)(wu)(wu)(wu)研(yan)發新(xin)篇章(zhang)。武(wu)漢(han)(han)植(zhi)(zhi)物(wu)(wu)(wu)(wu)園(yuan)(yuan)主任(ren)王(wang)青(qing)(qing)鋒(feng)、副(fu)(fu)主任(ren)黃(huang)偉、紀委(wei)書記賀鋒(feng)、天(tian)(tian)(tian)勤(qin)生物(wu)(wu)(wu)(wu)董事長任(ren)習(xi)東、總(zong)裁陸國(guo)才、執行副(fu)(fu)總(zong)裁胡大裕及(ji)植(zhi)(zhi)物(wu)(wu)(wu)(wu)園(yuan)(yuan)其他相關領(ling)導、負責(ze)人(ren)參加了(le)此(ci)次(ci)簽約儀式。資(zi)源(yuan)共享,合(he)(he)(he)作(zuo)共贏(ying)武(wu)漢(han)(han)植(zhi)(zhi)物(wu)(wu)(wu)(wu)園(yuan)(yuan)是我國(guo)三大核心科(ke)(ke)學植(zhi)(zhi)物(wu)(wu)(wu)(wu)園(yuan)(yuan)之一,在(zai)藥用植(zhi)(zhi)物(wu)(wu)(wu)(wu)資(zi)源(yuan)收集保育(yu)、功(gong)能性(xing)活性(xing)成分篩選(xuan)、作(zuo)用機(ji)理以(yi)及(ji)開(kai)發利(li)用等方面(mian)有(you)(you)著天(tian)(tian)(tian)然優勢(shi),而天(tian)(tian)(tian)勤(qin)生物(wu)(wu)(wu)(wu)在(zai)新(xin)藥研(yan)究與(yu)評價(jia)方面(mian)積累了(le)深厚的(de)(de)研(yan)究基礎,雙方將(jiang)以(yi)此(ci)次(ci)合(he)(he)(he)作(zuo)為契機(ji),在(zai)藥用植(zhi)(zhi)物(wu)(wu)(wu)(wu)活性(xing)成分挖掘、心血管藥物(wu)(wu)(wu)(wu)研(yan)發、平臺共建及(ji)人(ren)才培(pei)養等領(ling)域開(kai)展深度(du)合(he)(he)(he)作(zuo),加速推進(jin)科(ke)(ke)研(yan)成果的(de)(de)轉化與(yu)落地(di),打(da)造科(ke)(ke)研(yan)機(ji)構與(yu)企業(ye)合(he)(he)(he)作(zuo)共贏(ying)的(de)(de)典范。交流(liu)(liu)會(hui)(hui)上,武(wu)漢(han)(han)植(zhi)(zhi)物(wu)(wu)(wu)(wu)園(yuan)(yuan)主任(ren)王(wang)青(qing)(qing)鋒(feng)表示,此(ci)次(ci)合(he)(he)(he)作(zuo)架起了(le)雙方資(zi)源(yuan)深度(du)對(dui)接的(de)(de)重(zhong)要橋梁,必將(jiang)助推雙方提檔升(sheng)級,為中部地(di)區(qu)生物(wu)(wu)(wu)(wu)醫(yi)藥產業(ye)的(de)(de)穩健(jian)發展注入新(xin)的(de)(de)動能。天(tian)(tian)(tian)勤(qin)生物(wu)(wu)(wu)(wu)董事長任(ren)習(xi)東也在(zai)會(hui)(hui)上鄭重(zhong)承諾,將(jiang)以(yi)真抓實干全(quan)力(li)(li)(li)推進(jin)項(xiang)目(mu)落地(di),實現科(ke)(ke)研(yan)與(yu)產業(ye)的(de)(de)融合(he)(he)(he)發展。同(tong)向發力(li)(li)(li),協(xie)(xie)同(tong)育(yu)人(ren)創(chuang)(chuang)新(xin)人(ren)才培(pei)養體系(xi),培(pei)養高質量人(ren)才,是此(ci)次(ci)交流(liu)(liu)會(hui)(hui)達成的(de)(de)...

天勤生物助力恒瑞醫藥HRS-9813片獲批臨床

2024-07

近日,恒瑞醫藥(yao)(yao)(yao)子公司廣東恒瑞醫藥(yao)(yao)(yao)有(you)限(xian)公司(以下稱(cheng)“恒瑞醫藥(yao)(yao)(yao)”)研(yan)發(fa)的(de)(de)HRS-9813片正式獲(huo)(huo)得臨床試(shi)驗(yan)(yan)(yan)許(xu)可(ke)。作為(wei)一家經驗(yan)(yan)(yan)豐(feng)富的(de)(de)CRO企(qi)業,天(tian)勤(qin)生物(wu)(wu)(wu)(wu)為(wei)該項(xiang)目提(ti)供(gong)了(le)完(wan)(wan)整的(de)(de)毒理試(shi)驗(yan)(yan)(yan),以健全成(cheng)熟的(de)(de)服(fu)務(wu)體系助力該項(xiang)目高效(xiao)通(tong)關(guan),成(cheng)功獲(huo)(huo)批。 HRS-9813片是(shi)恒瑞醫藥(yao)(yao)(yao)的(de)(de)一款1類(lei)新藥(yao)(yao)(yao),擬用于治療特(te)發(fa)性(xing)肺纖(xian)維化,目前國內(nei)外(wai)尚(shang)無同(tong)類(lei)藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)獲(huo)(huo)批上(shang)(shang)市。此次順利獲(huo)(huo)批,也是(shi)天(tian)勤(qin)生物(wu)(wu)(wu)(wu)助力藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)研(yan)發(fa)快速落地的(de)(de)重要成(cheng)果(guo)之一。天(tian)勤(qin)生物(wu)(wu)(wu)(wu)子公司湖北(bei)天(tian)勤(qin)鑫圣生物(wu)(wu)(wu)(wu)科(ke)技有(you)限(xian)公司(以下稱(cheng)“天(tian)勤(qin)鑫圣”)針對藥(yao)(yao)(yao)物(wu)(wu)(wu)(wu)特(te)點與申(shen)報(bao)要求開展了(le)全套(tao)的(de)(de)毒理試(shi)驗(yan)(yan)(yan),在深度理解客戶(hu)需求的(de)(de)基礎上(shang)(shang),精(jing)心設計(ji)試(shi)驗(yan)(yan)(yan)方案,持續完(wan)(wan)善細節,全力助推項(xiang)目科(ke)學化、標(biao)準化完(wan)(wan)成(cheng)。 縮短試(shi)驗(yan)(yan)(yan)周期,加快創(chuang)新藥(yao)(yao)(yao)研(yan)發(fa)和轉(zhuan)化的(de)(de)進程,天(tian)勤(qin)生物(wu)(wu)(wu)(wu)多年(nian)來(lai)初(chu)心不改(gai),積累了(le)豐(feng)富的(de)(de)項(xiang)目經驗(yan)(yan)(yan)。截止至(zhi)目前,天(tian)勤(qin)生物(wu)(wu)(wu)(wu)擁有(you)1000多項(xiang)專題(ti)研(yan)究經驗(yan)(yan)(yan),200多個(ge)新藥(yao)(yao)(yao)申(shen)報(bao)品種(zhong),超過60個(ge)中外(wai)IND申(shen)報(bao)的(de)(de)品種(zhong)通(tong)過中國CFDA/NMPA 、美國FDA和澳大利亞TGA的(de)(de)審批進入臨床。著眼自主創(chuang)新技術突(tu)破(po),增強在非臨床安全評價領域的(de)(de)競爭力,力爭為(wei)客戶(hu)提(ti)供(gong)更(geng)加優質高效(xiao)的(de)(de)服(fu)務(wu),天(tian)勤(qin)生物(wu)(wu)(wu)(wu)始終向上(shang)(shang)而行。

天勤生物參加首屆美國華人生物醫藥科技協會(CBA)中國年會

2024-06

6月29日,首屆美國華人(ren)生(sheng)(sheng)物(wu)(wu)醫藥(yao)(yao)科技(ji)協會(CBA)中(zhong)國年會在蘇州國際博(bo)覽中(zhong)心圓(yuan)滿閉(bi)幕。本(ben)次大(da)會聚焦AI及新技(ji)術、小(xiao)分子AI制藥(yao)(yao)、核酸藥(yao)(yao)物(wu)(wu)創新、中(zhong)藥(yao)(yao)高質量發展等主(zhu)題,研(yan)(yan)討如(ru)何(he)提高臨床(chuang)研(yan)(yan)究和(he)新藥(yao)(yao)研(yan)(yan)發的(de)(de)(de)效率與(yu)(yu)質量。天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)應邀(yao)參(can)會,向來自全(quan)國各地的(de)(de)(de)與(yu)(yu)會者(zhe)全(quan)面展示了在藥(yao)(yao)物(wu)(wu)非臨床(chuang)安全(quan)評價(jia)方面的(de)(de)(de)服務(wu)能力和(he)研(yan)(yan)究成果。 天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)設(she)立專門展臺,與(yu)(yu)現場(chang)嘉賓零距(ju)離互(hu)動,面對面溝(gou)通(tong)。憑借在生(sheng)(sheng)物(wu)(wu)制品、化藥(yao)(yao)、中(zhong)藥(yao)(yao)、兒科用藥(yao)(yao)等方面積累(lei)的(de)(de)(de)非臨床(chuang)安全(quan)評價(jia)經驗和(he)成功案例,天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)立足(zu)客戶需(xu)求,向大(da)家(jia)詳細介紹了研(yan)(yan)究特色和(he)服務(wu)優勢(shi),展示出了深厚的(de)(de)(de)專業硬實力,食(shi)蟹猴生(sheng)(sheng)殖毒(du)性(xing)與(yu)(yu)發育毒(du)性(xing)研(yan)(yan)究平臺、大(da)動物(wu)(wu)疾(ji)病模(mo)型等特色服務(wu)也(ye)引起了現場(chang)來賓的(de)(de)(de)極大(da)興趣。

天勤生物參加2024年度湖北省實驗動物與安全性評價學術交流會

2024-06

2024年6月14日至(zhi)16日,以(yi)“實(shi)驗動(dong)物(wu)(wu)與(yu)(yu)安(an)全性(xing)(xing)評(ping)價”為(wei)主(zhu)題(ti)(ti)的(de)2024年度湖(hu)北省實(shi)驗動(dong)物(wu)(wu)與(yu)(yu)安(an)全性(xing)(xing)評(ping)價學(xue)術交(jiao)流會(hui)(hui)(hui)(hui)在(zai)(zai)湖(hu)北省襄陽市順利召(zhao)開,吸引了來(lai)自(zi)省內(nei)外的(de)實(shi)驗動(dong)物(wu)(wu)及毒理相關領域專(zhuan)家學(xue)者、管理人員、研(yan)究(jiu)人員近400人參(can)加。 本次(ci)大會(hui)(hui)(hui)(hui)除了開設主(zhu)會(hui)(hui)(hui)(hui)場(chang)外,還分(fen)(fen)(fen)(fen)(fen)設藥(yao)(yao)(yao)理毒理專(zhuan)場(chang)、實(shi)驗動(dong)物(wu)(wu)專(zhuan)場(chang)、“生(sheng)(sheng)物(wu)(wu)醫藥(yao)(yao)(yao)創(chuang)新賦能新質生(sheng)(sheng)產力”產業發(fa)展(zhan)論(lun)(lun)壇(tan)三個分(fen)(fen)(fen)(fen)(fen)會(hui)(hui)(hui)(hui)場(chang)。大會(hui)(hui)(hui)(hui)邀請到(dao)院士、知名專(zhuan)家作主(zhu)題(ti)(ti)學(xue)術報告,并開展(zhan)青年優(you)秀(xiu)論(lun)(lun)文(wen)評(ping)選(xuan)活動(dong)。期間,天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)武漢分(fen)(fen)(fen)(fen)(fen)公司的(de)機構負責人/副總經理田(tian)義超博(bo)士在(zai)(zai)藥(yao)(yao)(yao)理毒理專(zhuan)場(chang)分(fen)(fen)(fen)(fen)(fen)論(lun)(lun)壇(tan)上發(fa)表了精彩(cai)演(yan)講。 田(tian)博(bo)士圍繞(rao)生(sheng)(sheng)物(wu)(wu)類(lei)(lei)似藥(yao)(yao)(yao)的(de)非臨床評(ping)價這(zhe)一熱點(dian)話(hua)題(ti)(ti),以(yi)“神藥(yao)(yao)(yao)”司美格(ge)魯(lu)肽(tai)生(sheng)(sheng)物(wu)(wu)類(lei)(lei)似藥(yao)(yao)(yao)的(de)非臨床藥(yao)(yao)(yao)效學(xue)、藥(yao)(yao)(yao)代動(dong)力學(xue)和(he)毒理學(xue)研(yan)究(jiu)為(wei)案例,深入淺出地分(fen)(fen)(fen)(fen)(fen)享了天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)在(zai)(zai)這(zhe)一領域的(de)研(yan)究(jiu)成果與(yu)(yu)實(shi)踐心得。司美格(ge)魯(lu)肽(tai)作為(wei)一種備受矚(zhu)目的(de)治(zhi)療手段,其生(sheng)(sheng)物(wu)(wu)類(lei)(lei)似藥(yao)(yao)(yao)的(de)研(yan)發(fa)與(yu)(yu)評(ping)價,對于提升患者用藥(yao)(yao)(yao)可及性(xing)(xing)和(he)降低醫療成本具有重要意(yi)義。田(tian)博(bo)士的(de)報告內(nei)容(rong)翔實(shi)、分(fen)(fen)(fen)(fen)(fen)析透徹,榮(rong)膺大會(hui)(hui)(hui)(hui)優(you)秀(xiu)論(lun)(lun)文(wen)獎,彰顯了天(tian)勤(qin)生(sheng)(sheng)物(wu)(wu)在(zai)(zai)非臨床安(an)全研(yan)究(jiu)領域的(de)深厚底蘊與(yu)(yu)創(chuang)新能力。

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