中国生物制药:集团自主研发的1类创新药罗伐昔替尼上市获得药监局上市批准

财经网
Mar 02

近日,中国生物制药发布公告称,集团自主研发的国家1类创新药罗伐昔替尼片(商品名:安煦®)已获得中国国家药品监督管理局(NMPA)的上市批准,适用于中危-2或高危的原发性骨髓纤维化(PMF)、真性红细胞增多症后骨髓纤维化(PPV-MF)或原发性血小板增多症后骨髓纤维化(PET-MF)成年患者的一线治疗。在一项多中心、随机、双盲、双模拟、阳性药物平行对照的II期临床研究中,罗伐昔替尼对比羟基尿在治疗...

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