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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 National Medical Products Administration (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. In addition, 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. NMPA has given the acceptance of the New Drug Application (NDA) of 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
            • 2023-03-09
              Juventas Announces FDA Clearance of the IND Application for Clinical Trial of Inaticabtagene Autoleucel
            • 2022-12-22
              Juventas’ Inaticabtagene Autoleucel (CNCT19 Injection) Granted Priority Review by CDE, NMPA
            • 2022-12-13
              NMPA of China has accepted the NDA of 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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            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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            News  |  Events  |  Videos
            我們的目標 Focus on Cell Therapy, Lead a Healthy Future.
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            合源生物CNCT19相關管線
            平臺 項目 適應癥 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)相關臨床試驗列表
            登記號 方案標題 網址
            CTR20192701 CNCT19細胞注射液治療CD19陽性的復發或難治性急性淋巴細胞白血病的l期臨床試驗 http://www.chinablood.com.cn/system/2019/05/21/014 330776.shtml
            NCT04230473 CNCT19細胞注射液治療CD19陽性的復發或難治性急性淋巴細胞白血病的l期臨床試驗 https://clinicaltrials.gov/ct2/show/NCT04230473?term= NCT042304
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            CNCT19 研發歷程
            • 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產品介紹
            合源生物CNCT19細胞注射液是具有自主知識產權的針對CD19靶點的CAR-T細胞治療產品,源自中國醫學科學院血液病醫院(血液學研究所)長期技術創新積累。CNCT19細胞注射液于2019年11月29日獲得兩項國家藥品監督管理局新藥臨床試驗許可,分別為治療復發或難治性急性淋巴細胞白血病的臨床試驗(受理號:CXSL1800106)和治療復發或難治性侵襲性B細胞非霍奇金淋巴瘤的臨床試驗(受理號:CXSL1800107)。此次啟動會的舉行,標志著中國自主知識產權的CAR-T 細胞治療產品正式開展注冊臨床試驗并進行受試者招募,在臨床轉化和產業化發展道路上又邁出了關鍵一步,合源生物將加速推進CNCT19細胞注射液臨床研究進程,早日惠及患者。

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