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CAR-T疗法取得重要突破 银河生物能否借此弯道超车
目前,国内已涌现出安科生物、恒瑞医药、中源协和、银河生物等一大批投身CAR-T疗法研究的企业。
以处于业务转型期的银河生物为例,2015年11月,银河生物宣布与四川大学生物治疗国家重点实验室签署达成合作,共同合作开发靶向人VEGFR-1和人CD19的抗肿瘤CAR-T细胞I类新药SKLB083017、SKLB083019。公司也在致力于将CAR-T技术应用到细胞能够通透的实体瘤上,包括胰腺癌、肺癌等。目前,公司有2个产品正在进行GMP(生产质量管理规范)条件优化,希望能够在最短时间里具备申报临床条件。
2016年年底,银河生物公告子公司增资北京马力喏生物科技。通过增资马力喏,公司将率先以CAR-T治疗药物的形式在国内外同步申报临床,同时可与四川大学及四川大学生物治疗国家重点实验室合作开发CAR-T技术形成合力,提升公司在CAR-T等前沿肿瘤免疫治疗技术的研发效率,加快公司构建较为完善的药物研发体系,丰富未来CAR-T药物的产品线,确立公司在肿瘤免疫治疗领域的领先优势。
业内专家认为,诺华CAR-T技术获批上市,对国内的CAR-T企业无疑是个重大利好。但是CAR-T疗法要在我国上市,还需要有一个严格的审核过程。
此外,CAR-T技术昂贵的费用也超出了大多数普通人的承受能力。不过也有人认为,随着资本投入扩大和市场容量打开,未来CAR-T疗法的价格必定不可能如现在这般高昂。细胞制备过程的全自动化、标准化也是各大细胞治疗公司需要解决的问题。
另外,在政策规范和技术获得突破性发展的节点来临之际,会在一定程度上加速行业的强势洗牌,无资质、无技术的医疗机构和公司必定会出局,而真正具有技术和发展潜力的企业才能够成为在未来细胞治疗产业浪潮中的佼佼者。(桂衍民)
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