中国国家食品药品监督管理总局近期宣布将境内外均未上市的新型制剂新药定义为新药(2类),为新型制剂新药的研发产业化提供了政策支持。新型制剂新药是在化合物新药基础上开发出的新药,与化合物新药相比,具有副作用更小、疗效更优、患者顺应性更好等优点,新型制剂产品上市后通常会取代第一代普通制剂产品。近年来,中国新化合物新药的研发发展迅速、硕果累累,产生了诸如埃克替尼、西达本胺等重磅级的化合物新药产品,但仍无国际认可的NDA新药产品。因此,开发研发成本低(仅为化合物新药开发成本的1%~3%)、周期短(约占化合物新药开发周期的1/2~1/3)、成功率高的新型制剂新药,是中国医药企业创新药研发走出国门,并取得国际认可的又一途径。以口服固体缓控释产品为例,阐述了新型制剂新药的特点及其对患者、企业和国家的意义,探讨了推动新型制剂新药发展的政策落地问题,表明开发新型制剂新药既符合中国当前科技创新的既定目标,又可以给医药行业发展带来巨大的推动作用。
CFDA has recently announced new classification guidance for drug product application. Under this new guidance, drug product with modified dosage regimen, dosage forms etc. (second generation products) are defined as new drugs. Comparing with first generation NCE based drug products, these second generation tend to have less adverse effect, longer effective time and better patient compliance. Although Chinese companies have launched quite few NCE based drug products domestically no NDA product has gained approval from FDA. Developing products with modified dosage regimen, dosage forms etc. could be an alternative way for innovative drug products to be recognized internationally because these types of product development will have less financial requirement, higher success rate and shorter development time. Using solid oral modified release products as examples, this article has reviewed a variety of modified release technologies and their application in product development. Sales data are used to show the importance of these products. It has also indicated different aspects and considerations to develop modified release products.
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