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和鉑醫藥-B：自願公告 - HBM9027臨床試驗啟動獲美國食品及藥物監督管理局新藥研究許可

HBM HOLDINGS-B: VOLUNTARY ANNOUNCEMENT - FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES IND CLEARANCE FOR HBM9027 CLINICAL TRIAL INITIATION

香港交易所 ·  Jan 23 23:25
Summary by Moomoo AI
和鉑醫藥-B（02142）宣布，其開發的雙特異性抗體HBM9027已獲得美國食品及藥物監督管理局（FDA）的新藥研究申請許可（IND），將在美國啟動首次人體（FIH）臨床試驗。該I期試驗旨在評估HBM9027在晚期實體瘤患者中的安全性、耐受性、藥代動力學和抗腫瘤活性。HBM9027基於和鉑醫藥專有的全人源HBICE®平台開發，是一種新型PD-L1xCD40雙特異性抗體，旨在激活依賴PD-L1交聯的CD40，並在臨床前研究中展示出良好的安全性和強大的抗腫瘤效果。公司提醒潛在投資者買賣股份時應審慎行事，並警示無法保證HBM9027能成功開發或最終銷售。本公告由公司主席及執行董事王勁松博士於2024年1月24日發布。
和鉑醫藥-B（02142）宣布，其開發的雙特異性抗體HBM9027已獲得美國食品及藥物監督管理局（FDA）的新藥研究申請許可（IND），將在美國啟動首次人體（FIH）臨床試驗。該I期試驗旨在評估HBM9027在晚期實體瘤患者中的安全性、耐受性、藥代動力學和抗腫瘤活性。HBM9027基於和鉑醫藥專有的全人源HBICE®平台開發，是一種新型PD-L1xCD40雙特異性抗體，旨在激活依賴PD-L1交聯的CD40，並在臨床前研究中展示出良好的安全性和強大的抗腫瘤效果。公司提醒潛在投資者買賣股份時應審慎行事，並警示無法保證HBM9027能成功開發或最終銷售。本公告由公司主席及執行董事王勁松博士於2024年1月24日發布。
AND PLATINUM PHARMACEUTICAL-B (02142) ANNOUNCED THAT ITS DEVELOPED BI-SPECIFIC ANTIBODY HBM9027 HAS RECEIVED A NEW DRUG RESEARCH APPLICATION (IND) LICENSE FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND WILL LAUNCH ITS FIRST HUMAN BODY (FIH) CLINICAL TRIAL IN THE UNITED STATES. The Phase I trial was designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of HBM9027 in patients with late-stage solid tumors. Developed on the all-human HBICE® platform, based on and proprietary to platinum medicine, HBM9027 is a novel PD-L1xCD40 dual-specific antibody designed to activate PD-L1-dependent CD40 and demonstrated good safety and strong antitumor effects in preclinical studies. The Company reminds potential investors to exercise caution when buying and selling shares and cautions that HBM9027 cannot guarantee successful development or eventual sale. This announcement was made by Dr. Wang Jinsong, Chairman and Executive Director of the Company, on 24 January 2024.
AND PLATINUM PHARMACEUTICAL-B (02142) ANNOUNCED THAT ITS DEVELOPED BI-SPECIFIC ANTIBODY HBM9027 HAS RECEIVED A NEW DRUG RESEARCH APPLICATION (IND) LICENSE FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND WILL LAUNCH ITS FIRST HUMAN BODY (FIH) CLINICAL TRIAL IN THE UNITED STATES. The Phase I trial was designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of HBM9027 in patients with late-stage solid tumors. Developed on the all-human HBICE® platform, based on and proprietary to platinum medicine, HBM9027 is a novel PD-L1xCD40 dual-specific antibody designed to activate PD-L1-dependent CD40 and demonstrated good safety and strong antitumor effects in preclinical studies. The Company reminds potential investors to exercise caution when buying and selling shares and cautions that HBM9027 cannot guarantee successful development or eventual sale. This announcement was made by Dr. Wang Jinsong, Chairman and Executive Director of the Company, on 24 January 2024.
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