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石藥集團：自願公告 - CPO301取得美國FDA快速通道資格

CSPC PHARMA: VOLUNTARY ANNOUNCEMENT - CPO301 RECEIVES FAST TRACK DESIGNATION FROM THE US FDA

HKEX ·  Oct 8 16:55

Summary by Futu AI

石藥集團有限公司（「本公司」）宣布，其開發的抗體藥物偶聯物CPO301獲得美國食品藥品監督管理局（FDA）授予的快速通道資格。CPO301用於治療表皮生長因子受體（EGFR）過度表達且病情在接受含鉑方案化療及抗PD-(L1)治療後出現進展的復發或轉移性鱗狀非小細胞肺癌（NSCLC）患者。該藥物在中國及美國的I期研究中顯示出良好的療效及安全性。這是CPO301獲得的第二項快速通道資格，旨在加速其在美國的發展。石藥集團於2024年10月8日由董事會主席蔡東晨宣布此消息。
石藥集團有限公司（「本公司」）宣布，其開發的抗體藥物偶聯物CPO301獲得美國食品藥品監督管理局（FDA）授予的快速通道資格。CPO301用於治療表皮生長因子受體（EGFR）過度表達且病情在接受含鉑方案化療及抗PD-(L1)治療後出現進展的復發或轉移性鱗狀非小細胞肺癌（NSCLC）患者。該藥物在中國及美國的I期研究中顯示出良好的療效及安全性。這是CPO301獲得的第二項快速通道資格，旨在加速其在美國的發展。石藥集團於2024年10月8日由董事會主席蔡東晨宣布此消息。
CSPC Pharma Limited ("the Company") announced that its developed antibody-drug conjugate CPO301 has been granted Fast Track designation by the US Food and Drug Administration (FDA). CPO301 is used to treat recurrent or metastatic squamous non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) overexpression whose disease has progressed after receiving platinum-based chemotherapy and anti-PD-(L1) therapy. The drug has demonstrated good efficacy and safety in Phase I studies in China and the USA. This is the second Fast Track designation obtained by CPO301, aimed at accelerating its development in the USA. The announcement was made by the board of directors on October 8, 2024, led by Chairman Cai Dongchen.
CSPC Pharma Limited ("the Company") announced that its developed antibody-drug conjugate CPO301 has been granted Fast Track designation by the US Food and Drug Administration (FDA). CPO301 is used to treat recurrent or metastatic squamous non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) overexpression whose disease has progressed after receiving platinum-based chemotherapy and anti-PD-(L1) therapy. The drug has demonstrated good efficacy and safety in Phase I studies in China and the USA. This is the second Fast Track designation obtained by CPO301, aimed at accelerating its development in the USA. The announcement was made by the board of directors on October 8, 2024, led by Chairman Cai Dongchen.
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