* 中国生物科技公司康方生物9926.HK周一早盘低开15%,随后跌幅扩大至19.1%,报80港元。
* 该公司此前公告称,依沃西的第二个适应症上市申请获得中国国家药监局批准,用于一线治疗PD L1阳性非小细胞肺癌。获批上市基于的III期临床试验是与最畅销药物--帕博利珠单抗的头对头比较。
* 临床研究还进行了总生存期(OS)的期中分析,结果显示,风险比(HR)为0.777,意思就是死亡风险降低了22.3%(=1-0.777)。公司为本次期中分析分配了极低的α检验水准,仅为0.0001,是一个很严苛的水准。
* 美国投行富瑞在报告中表示,市场对数据有争议,但从医生的角度看,HR<0.8就具有临床意义。这一数据令人鼓舞,该药物具有进一步扩展适应症的潜力。
富瑞并指,相信如果在最终分析时分配更高的α检验水准,最终的总生存期结果能达到统计学显著性(根据方案设计,届时HR需<0.774)。市场普遍预期最终总生存期的HR在0.75-0.78之间,富瑞对药物达到此目标有信心。
* 野村在报告中表示,将康方生物目标价从75.14港元上调至99.66港元,但因近期股价上涨,将评级从“买入”下调至“中性”。野村称,中期总生存期HR的数据“良好,但非决定性”。(完)
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(发稿 徐凯文;审校 杨淑祯)
((kaiwen.xu@thomsonreuters.com))
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