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Founded in June 2018, Juventas Cell Therapy Ltd. is a biopharmaceutical company focusing on the R&D and commercialization of innovative drugs such as immune cell therapy, which has in-depth cooperation with national first-class institutes and clinical research centers and is committed to building a leading platform for clinical transformation and commercialization of cell therapy, accelerating cell therapy innovation, clinical application, and commercialization.


Juventas Cell Therapy has been regarding patients medical clinical needs as the guide. With rigorous manufacturing and quality control systems, we are committed to producing safe, effective, and accessible immune cell therapy products. In addition, we continuously build expansible and internationally competitive portfolio pipeline, coverage spanning from hematologic malignancies, solid tumors, and self-immune diseases. The company has more than 10 product candidates represented by innovative single/multiple target products, universal cell therapy products. Furthermore, Juventas Cell Therapy has the world’s high-level R&D technology platform, CMC development platform, quality control system, and commercialization plant. In June 2021, our commercialization plant was granted the first Drug Production License for cell therapy product in Tianjin Municipal. Besides, the company possesses a large number of patents for invention. In 2020, our product was selected in “Science and Technology Advance Economy 2020 Key Special Project”, a significant national R&D project supported by Ministry of Science and Technology of the People's Republic of China.


Products
Products

Inaticabtagene Autoleucel (CNCT19 Injection) is the first core product candidate of Juventas Cell Therapy, it is also the first CD19-directde CAR-T product with Chinese independent intellectual property rights. CD19 scFv (HI19a) structure and CMC technique. It has obtained three IND approval from the NMPA, for the treatment of adult relapsed and refractory acute lymphoblastic leukemia, relapsed and refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent B-cell acute lymphoblastic leukemia. It was granted Breakthrough Therapy Designation by Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) and Orphan Drug Designation (ODD) by the U.S. FDA. Nov 2023, China’s National Medical Product Administration (NMPA) has formally approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), for the treatment of adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

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R&D Progress
R&D Progress
  • 2025-04-24
    Juventas Announces NMPA Clearance of Ina-cel for the Treatment of Lupus Nephritis (LN)
  • 2025-04-11
    Juventas Announces NMPA Clearance for Global First-in-Class CAR-T Ina-cel for the Treatment of Autoimmune Hemolytic Anemia (AIHA)
  • 2024-11-07
    Juventas Announces the Launch of Inaticabtagene Autoleucel Injection for Marketing In Macao?
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Clinical Research
Clinical Research

Clinical development abilities and scalable pipeline layout demonstrate the vitality of an excellent biomedical company. Juventas develops by technological innovation covering blood and solid tumors to meet clinical demands and accelerate industrialization.

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我們的目標(biāo) Focus on Cell Therapy, Lead a Healthy Future.
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合源生物CNCT19相關(guān)管線
平臺(tái) 項(xiàng)目 適應(yīng)癥 臨床前研究
血液腫瘤 CD19 CAR-T (CNCT19) B-ALL 2019.11.29 IND, 2020.01.15 受試者入組
合源生物CNCT19 (CD19 CAR-T)相關(guān)臨床試驗(yàn)列表
登記號(hào) 方案標(biāo)題 網(wǎng)址
CTR20192701 CNCT19細(xì)胞注射液治療CD19陽(yáng)性的復(fù)發(fā)或難治性急性淋巴細(xì)胞白血病的l期臨床試驗(yàn) http://www.chinablood.com.cn/system/2019/05/21/014 330776.shtml
NCT04230473 CNCT19細(xì)胞注射液治療CD19陽(yáng)性的復(fù)發(fā)或難治性急性淋巴細(xì)胞白血病的l期臨床試驗(yàn) https://clinicaltrials.gov/ct2/show/NCT04230473?term= NCT042304
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CNCT19 研發(fā)歷程
  • 2020年3月4日 CNCT19首例受試者成功回輸
  • 2020年3月4日 CNCT19首例受試者成功回輸
  • 2020年3月4日 CNCT19首例受試者成功回輸
  • 2020年3月4日 CNCT19首例受試者成功回輸
  • 2020年3月4日 CNCT19首例受試者成功回輸
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CNCT19產(chǎn)品介紹
合源生物CNCT19細(xì)胞注射液是具有自主知識(shí)產(chǎn)權(quán)的針對(duì)CD19靶點(diǎn)的CAR-T細(xì)胞治療產(chǎn)品,源自中國(guó)醫(yī)學(xué)科學(xué)院血液病醫(yī)院(血液學(xué)研究所)長(zhǎng)期技術(shù)創(chuàng)新積累。CNCT19細(xì)胞注射液于2019年11月29日獲得兩項(xiàng)國(guó)家藥品監(jiān)督管理局新藥臨床試驗(yàn)許可,分別為治療復(fù)發(fā)或難治性急性淋巴細(xì)胞白血病的臨床試驗(yàn)(受理號(hào):CXSL1800106)和治療復(fù)發(fā)或難治性侵襲性B細(xì)胞非霍奇金淋巴瘤的臨床試驗(yàn)(受理號(hào):CXSL1800107)。此次啟動(dòng)會(huì)的舉行,標(biāo)志著中國(guó)自主知識(shí)產(chǎn)權(quán)的CAR-T 細(xì)胞治療產(chǎn)品正式開展注冊(cè)臨床試驗(yàn)并進(jìn)行受試者招募,在臨床轉(zhuǎn)化和產(chǎn)業(yè)化發(fā)展道路上又邁出了關(guān)鍵一步,合源生物將加速推進(jìn)CNCT19細(xì)胞注射液臨床研究進(jìn)程,早日惠及患者。
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