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基石药业-B(02616.HK):RET抑制剂普吉华®(普拉替尼胶囊)由境外转移至境内生产的药品上市注册申请已获国家药监局药品审评中心受理
格隆汇 04-09 08:05

格隆汇4月9日丨基石药业-B(02616.HK)发布公吿,RET抑制剂普吉®(普拉替尼胶囊)转移至境内生产的药品上市注册申请已获中国国家药品监督管理局 (NMPA)药品审评中心受理。此前,基石药业另一款精准治疗药物泰吉®(阿伐替尼片)转移至境内生产的药品上市注册申请已在 2023年6月获药审中心受理,目前正在审评中,预计2024年将实现国内供应。

基石药业首席执行官兼执行董事杨建新博士表示:“普吉华®与泰吉华®转移至境内生产的两项上市注册申请先后获得受理,对于基石药业具有重大的意义,意味着公司将有望在短期内实现上述两个产品的本地化生产,这不仅能够实现超过50%的药品生产成本降幅,还能增加产品供应的灵活性、更好地满足国内市场需求、惠及更多国内患者,并将进一步拓展普吉华®与泰吉华®在中国市场的竞争优势。最近,国家陆续推出了一系列地产化相关支持性政策,如简化申报资料、明确申报路径、优化申报流程等。NMPA在新出的优化程序征求意见稿中明确该类地产化申请适用优先审评审批程序。作为地产化药品的探索者,我们期待这些政策能够加速地产化药品的批准和上市进程,从而使基石药业能够迅速扩大普吉华®与泰吉华®的适应症范围。” 

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