科润生物喜获“注射用重组羧肽酶G2”临床试验批件
近日，历时8年艰苦攻关，科润自主开发的治疗用生物制品一类新药——注射用重组羧肽酶G2获得国家食品药品监督管理总局颁发的《药物临床试验批件》。在当前生物药审评日趋严格的形势下，该产品的成功获批是对科润团队技术水平和卓越毅力的再一次肯定。到目前为止，科润团队已获得3个生物新药临床批件，生物药研发产品线得到了进一步丰富。
重组羧肽酶G2是一种肿瘤治疗药物，为国内独家品种，填补了国内在大剂量甲氨蝶呤化疗后中毒解救治疗的空白，给广大肿瘤患者带来了福音。与现有治疗方式比较，该药物所开创的治疗方法具有显著优势，开辟了国内在该适应症治疗方法上的先河。大剂量的甲氨蝶呤化疗作为骨肉瘤、白血病及淋巴瘤等癌症的一线治疗手段，具有很好的疗效，但部分患者可因各种原因导致毒性反应而危及生命。科润研发的注射用重组羧肽酶G2，可在不影响化疗效果的前提下，将血浆中的甲氨蝶呤迅速降解为无毒性代谢产物排出体外，避免毒性反应的发生。
经过8年的技术攻关，本产品在药物制备方法、制剂配方方面取得了自主知识产权，显著降低了产品生产成本和提高了产品质量。目前，在美国上市的同类产品市场价格超过30万元人民币。目前公司正积极推进临床研究和产业化开发。本品上市后，可大幅降低成本，极大地提高了患者对药物的可及性。保守估计，该药物在国内的潜在市场超过50亿元/年。
{"weixin":{"label":"微信","name":"weixin","selected":true,"value":false,"sortid":"1","shareid":"weixin","sharetitle":"分享到微信","event":"shareToWeiXin","lang":"shareWeb_WeiXin"},"copy":{"label":"复制网址","name":"copy","selected":true,"value":false,"sortid":"2","shareid":"copy","sharetitle":"复制网址","event":"copy_url","lang":"shareWeb_Copy"},"qq":{"label":"QQ好友","name":"qq","selected":true,"value":false,"sortid":"2","shareid":"qq","sharetitle":"分享到QQ","event":"shareToQQ","lang":"shareWeb_QQ"},"sina_weibo":{"label":"新浪微博","name":"sina_weibo","selected":true,"value":false,"sortid":"4","shareid":"sina_weibo","sharetitle":"分享到新浪微博","event":"shareToSinaWB","lang":"shareWeb_SinaWeiBo"},"qq_zone":{"label":"QQ空间","name":"qq_zone","selected":true,"value":false,"sortid":"5","shareid":"qq_zone","sharetitle":"分享到QQ空间","event":"shareToQzone","lang":"shareWeb_QQZone"},"renren":{"label":"人人网","name":"renren","selected":true,"value":false,"sortid":"7","shareid":"renren","sharetitle":"分享到人人网","event":"shareToRenren","lang":"shareWeb_RenRen"},"douban":{"label":"豆瓣网","name":"douban","selected":true,"value":false,"sortid":"8","shareid":"douban","sharetitle":"分享到豆瓣网","event":"shareToDouban","lang":"shareWeb_DouBan"},"baidu_tieba":{"label":"百度贴吧","name":"baidu_tieba","selected":true,"value":false,"sortid":"10","shareid":"baidu_tieba","sharetitle":"分享到百度贴吧","event":"shareToTieba","lang":"shareWeb_TieBa"},"Facebook":{"label":"Facebook","name":"Facebook","selected":true,"value":true,"sortid":"11","shareid":"Facebook","sharetitle":"分享到FaceBook","event":"shareToFacebook","lang":"shareWeb_Facebook"},"Twitter":{"label":"Twitter","name":"Twitter","selected":true,"value":true,"sortid":"12","shareid":"Twitter","sharetitle":"分享到Twitter","event":"shareToTwitter","lang":"shareWeb_Twitter"},"LinkedIn":{"label":"LinkedIn","name":"LinkedIn","selected":true,"value":true,"sortid":"13","shareid":"LinkedIn","sharetitle":"分享到linkedIn","event":"shareToLinkedin","lang":"shareWeb_Linkedin"},"whatsapp":{"label":"whatsapp","name":"whatsapp","selected":true,"value":true,"sortid":"15","shareid":"whatsapp","sharetitle":"分享到whatsapp","event":"shareToWhatsapp","lang":"shareWeb_whatsapp"},"line":{"label":"line","name":"line","selected":true,"value":true,"sortid":"15","shareid":"line","sharetitle":"分享到line","event":"shareToLine","lang":"shareWeb_line"},"qq_weibo":{"label":"腾讯微博","name":"qq_weibo","selected":true,"value":true,"sortid":"3","shareid":"qq_weibo","sharetitle":"分享到腾讯微博","event":"shareToQQwb","lang":"shareWeb_QQWeiBo"},"peopleBlog":{"label":"人民微博","name":"propleBlog","selected":true,"value":true,"sortid":"14","shareid":"propleBlog","sharetitle":"分享到人民微博","event":"shareToPeopleBlog","lang":"shareWeb_peopleBlog"}}