智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，JSKN003已获美国食品药品监督管理局(FDA)授予快速通道资格认定(FTD)，用于治疗不限人表皮生长因子受体2( HER2)表达水平的铂耐药复发性上皮性卵巢癌、塬发性腹膜癌或输卵管癌(统称为PROC)。这标志着JSKN003全球开发进程中的又一重要里程碑。
除此之外，JSKN003已获美国FDA批准开展一项治疗不限HER2表达水平的PROC的II期临床试验，且分别在PROC和结肠直肠癌(CRC)上获国家药品监督管理局( 国家药监局)药品审评中心授予突破性疗法认定，并在胃╱胃食管结合部癌 (GC/GEJ)上获美国FDA授予孤儿药资格认定。且JSKN003用于治疗不限HER2表达水平的PROC的III期临床试验正在中国顺利开展中。此次FTD的获授进一步彰显了国际监管机构对JSKN003的临床潜力及其作为新型治疗候选药物重要性的信心。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.