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科濟藥業-B：自願公告 - CT011已獲得國家藥品監督管理局的IND批准用於治療手術切除後出現復發風險的GPC3陽性的IIIa期肝細胞癌患者

CARSGEN-B: VOLUNTARY ANNOUNCEMENT - CT011 ACHIEVED IND CLEARANCE FROM THE NMPA FOR PATIENTS WITH GPC3-POSITIVE STAGE IIIa HEPATOCELLULAR CARCINOMA AT HIGH RISK OF RECURRENCE AFTER SURGICAL RESECTION

香港交易所 ·  Jan 14 19:00
Summary by Moomoo AI
科濟藥業控股有限公司（「科濟藥業」）於2024年1月15日宣布，其自體CAR-T細胞候選產品CT011已獲得國家藥品監督管理局的IND批准，用於治療手術切除後有復發風險的GPC3陽性IIIa期肝細胞癌患者。CT011是中國首個針對實體瘤的CAR-T細胞療法獲得IND批准，並已完成I期臨床試驗的患者入組。科濟藥業專注於創新CAR-T細胞療法，旨在提高治療安全性、效果及降低成本，致力於成為全球癌症細胞療法的領導者。公司提醒股東及潛在投資者，CT011的開發或銷售成功無法得到保證，買賣股份時應審慎行事。
科濟藥業控股有限公司（「科濟藥業」）於2024年1月15日宣布，其自體CAR-T細胞候選產品CT011已獲得國家藥品監督管理局的IND批准，用於治療手術切除後有復發風險的GPC3陽性IIIa期肝細胞癌患者。CT011是中國首個針對實體瘤的CAR-T細胞療法獲得IND批准，並已完成I期臨床試驗的患者入組。科濟藥業專注於創新CAR-T細胞療法，旨在提高治療安全性、效果及降低成本，致力於成為全球癌症細胞療法的領導者。公司提醒股東及潛在投資者，CT011的開發或銷售成功無法得到保證，買賣股份時應審慎行事。
Kozhi Pharmaceutical Holdings Limited (“Kozhi Pharmaceuticals”) announced on 15 January 2024 that its autologous CAR-T cell candidate product CT011 has received IND approval from the National Drug Administration for the treatment of GPC3-positive stage IIIa liver cell cancer patients at risk of recurrence after surgical excision. CT011 is the first CAR-T cell therapy for solid tumors in China to receive IND approval and has enrolled patients who have completed Phase I clinical trials. Focusing on innovative CAR-T cell therapies to improve treatment safety, efficacy and lower costs, Kozin Pharmaceuticals is committed to becoming a global leader in cancer cell therapy. The Company reminds shareholders and potential investors that the development or sale of CT011 cannot be guaranteed and that caution should be exercised when buying and selling shares.
Kozhi Pharmaceutical Holdings Limited (“Kozhi Pharmaceuticals”) announced on 15 January 2024 that its autologous CAR-T cell candidate product CT011 has received IND approval from the National Drug Administration for the treatment of GPC3-positive stage IIIa liver cell cancer patients at risk of recurrence after surgical excision. CT011 is the first CAR-T cell therapy for solid tumors in China to receive IND approval and has enrolled patients who have completed Phase I clinical trials. Focusing on innovative CAR-T cell therapies to improve treatment safety, efficacy and lower costs, Kozin Pharmaceuticals is committed to becoming a global leader in cancer cell therapy. The Company reminds shareholders and potential investors that the development or sale of CT011 cannot be guaranteed and that caution should be exercised when buying and selling shares.
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