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重大新药创制紧盯临床需求
文章来源:中国医药化工网    添加人:admin    添加时间:2016/12/8 15:45:15
 
 重大新药创制科技重大专项2015年度课题申报工作启动,集中瞄准前沿技术,扶持企业开展有助于解决“瓶颈”性问题的关键技术和具有战略作用的培育性技术研究
 
  “新开题的重大新药创制科技重大专项(下称‘专项’)相比往年,更注重支持全新机制且无上市药物的创新品种研发。同时对严重危害健康的恶性肿瘤等10类重大疾病,开展具有重要临床价值的创新药物研究。对照课题表,我们有几个靶向药物在研项目符合要求,将组织人手积极申报。”这是江苏恒瑞医药副总经理沈灵佳看到相关通知后的第一感受。他对记者说,毕竟就算没有国家支持,企业也在做。如果能获批的话,除了国家经费支持外,更让人看中的是国家层面的认可。
 
  3月19日,国家卫计委发文启动该专项2015年度课题申报工作。沈灵佳详读了申报指南,“课题集中瞄准了国际上的前沿技术,扶持企业开展有助于解决‘瓶颈’性问题的关键技术和具有战略作用的培育性技术研究,鼓励创新的思维更具国际化视野。”
 
  定向择优
 
  从品种研发来看,新增课题重点针对恶性肿瘤、心脑血管疾病、神经退行性疾病、精神性疾病、糖尿病、自身免疫性疾病、重大病毒感染性疾病等10类重大疾病开展研究。“国家政策重点突出扶强。”沈灵佳说,至于申请能否获批,还需看后续审评结果。
 
  开展重大品种及核心技术的国际合作研究是这次扶持的重点。2013年,全球药企研发支出前20位中,有8家支出相对减少。而就疾病领域而言,最热门的就是肿瘤和代谢、内分泌疾病领域。合作创新逐渐被国内外的药企认同。作为国家重大新药创制专项的承担单位,先声药业7个国际合作项目中,有5个已进入临床研究。
 
  用先声药业副总裁殷晓进的话说,“这让我们的研发体系更开放、与国际更接轨,同时还吸引了海外人才,建立起国际化的管理体系,进而为产品走向主流市场提供支撑。”
 
  记者观察到,先声药业和BMS共同开发的抗肿瘤创新药麦他替尼就是发挥了中国低研发成本和临床试验病例丰富的优势,加速提升创新药的研发效率。
 
  “国家鼓励企业成为创新主体,鼓励其先行投入,联合科研院所开展研发,专项采取立项配套或后补助的方式支持。指南还特别强调要明晰知识产权、风险共担、利益分享的国际合作研究。”专家认为,这会提升我国药物研发的品质和效率。
 
  2015年的立项工作将采取“定向择优”为主、“滚动支持”为辅、“公开择优”为补充的方式组织。其中,对化药领域重点关注神经精神系统疾病(BACE等靶点)、代谢系统疾病(PCSK9等靶点)、肿瘤靶向及免疫治疗(WNT等靶点)新机制和新靶点药物品种研究。中药领域则重点支持开展临床优势突出的创新中药的临床研究。生物药领域支持新结构抗体、抗体偶联药物、全新结构蛋白及多肽药物、生物类似药、疫苗等具备较好成药性研究基础的创新品种。
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