科润生物再出1类新药，可解肿瘤化疗引起的肾中毒
近期，公司自主研发的生物制品1类新药-“注射用重组羧肽酶G2”，目前已向重庆市食品药品监督管理局提交了新药临床申请，于4月中旬顺利完成现场核查工作。5月13日，该品种已获国家食品药品监督管理总局药品审评中心受理通知书。
Glucarpidase（羧肽酶）商品名Voraxaze（谷卡匹酶），最早由英国制药公司BTG公司研发，用于降低因肾功能受损而导致化疗药物甲氨蝶呤（MTX）清除时间延长后体内出现的中毒水平。Voraxaze（谷卡匹酶）于2011年9月被FDA授予了孤儿药地位，并于2012年1月获FDA批准上市，由BTG公司在美国市场销售，并拥有7年的市场独占权。
羧肽酶G2( carboxypeptidase G2，CPG2) 是羧肽酶的一种，可特异性地作用于游离羧基末端为谷氨酸的MTX，将MTX 酶解为无毒性的代谢产物4-脱氧-4-氨基-N10-甲基蝶酸(DAMPA)和谷氨酸, 从而提供了一条可替代肾脏排出MTX 的途径，迅速降低MTX 的血液水平。CPG2 相对分子质量达8.3万，不易通过细胞膜，只能酶解血液中大量游离的MTX，因此并不影响肿瘤细胞内MTX 的抗肿瘤活性。
作为国家“十一五”重组蛋白药物中试平台，科润生物十几年来一直坚持关注细分市场，走差异化发展道路的研发战略。公司目前有多个项目处于临床前研究阶段，并积极开展新项目立项储备工作和哺乳动物细胞表达平台的拓展。
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