体内CAR-T疗法
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细胞与基因治疗“变天了”
Ge Long Hui· 2025-11-06 12:03
细胞与基因治疗(CGT)领域就像是一座围城,城外的人想进去,城里的人想出来。 一方面,艾伯维、百时美施贵宝(BMS)等MNC巨头纷纷入局体内CAR-T疗法,礼来也在近期宣布收购一家眼科基因治疗公司Adverum;另一方面,武田 制药、诺和诺德却接连宣布彻底退出细胞疗法战场,罗氏、辉瑞、渤健等跨国巨头也在集体逃离AAV基因治疗赛道。 这一进一退之间,CGT领域的"冰火两重天"格局,从未如此清晰过。这背后到底隐藏着什么秘密?CGT市场的出路究竟在何方? 01 繁荣下的脆弱 因治疗机制独特、临床疗效显著,CGT领域曾一度掀起热潮。 在今年9月举办的FDA公众听证会上,FDA CBER治疗产品办公室(OTP)代理主任VijayKumar博士表示,在过去十年中,CGT领域发展迅速,目前FDA已 经批准了46个CGT产品,并有约3600个活跃的IND。 不过,受生产工艺、成本、支付和市场准入等多重因素影响,CGT药物的销售表现呈现出鲜明的分化特征,且商业化效率远不及传统药物。 尽管目前全球范围内已有超过10款CAR-T疗法获批上市,但诞生的"十亿美元分子"却寥寥无几。其中,吉利德Yescarta(阿基仑赛)在2022年成 ...
原启生物与Umoja Biopharma达成战略合作 携手开发下一代细胞疗法
Sou Hu Wang· 2025-05-08 08:35
Group 1 - Oricell Therapeutics and Umoja Biopharma announced a strategic collaboration to develop innovative in vivo CAR-T therapies for various indications, aiming to provide efficient and accessible treatment options for patients globally [1][2] - Umoja's VivoVec™ platform enables the direct generation of CAR-T cells within patients, enhancing the convenience and effectiveness of treatment [1][2] - Oricell contributes its expertise in antibody discovery and CAR structure design, which has demonstrated best-in-class efficacy and safety in clinical data for products Ori-C101 and OriCAR-017 [1][3] Group 2 - Umoja Biopharma focuses on developing innovative in vivo cell therapies to improve the accessibility and effectiveness of CAR-T therapies in oncology and autoimmune diseases [2] - The company operates an advanced lentiviral vector development and production facility in Colorado, ensuring high-quality and safe products through GMP-compliant manufacturing processes [2] - Oricell is dedicated to becoming a leading innovator in tumor immunotherapy, addressing unmet clinical needs in oncology and immunology through its proprietary platforms and product pipelines [3]