信達生物(01801.HK)治療肺癌抑制劑獲內地受理新藥上市許可申請
信達生物(01801.HK)公布,國家藥監局(NMPA)已經正式受理IBI-351(KRAS G12C抑制劑)的新藥上市許可申請(NDA)並納入優先審評程序,用於治療至少接受過一種系統性治療的KRAS G12C突變型的晚期非小細胞肺癌(NSCLC)患者。
公司指出,IBI-351是中國首個遞交NDA的KRAS G12C抑制劑,並納入優先審評,有望盡早惠及KRAS G12C突變的肺癌患者。
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