復星醫藥(600196.SH)：控股子公司簽署許可協議 涉CXCR4拮抗劑Balixafortide及相關產品/組合
格隆匯 8 月 30日丨復星醫藥(600196.SH)公佈，公司控股子公司Fosun Pharmaceutical AG (“Fosun Pharma AG”，註冊地為瑞士盧塞恩)獲Polyphor Ltd (“Polyphor”)許可在區域內(即中國大陸及港澳台地區，下同)及領域內(即治療、診斷及/或預防人類任何疾病，下同)使用其專利、專有技術(Know-how)及改進獨家臨牀開發、商業化(不包括製造，下同)CXCR4拮抗劑Balixafortide (POL6326) (“Balixafortide”)以及相關產品/組合(即包含或含有Balixafortide的任何藥物產品及/或與其他活性成分的組合，下同)。
截至公告日，Balixafortide已於美國等地區完成聯用甲磺酸艾立布林注射液針對HER2陰性轉移性乳腺癌的Ib期臨牀研究，並正在開展聯用甲磺酸艾立布林注射液治療HER2陰性轉移性乳腺癌的國際多中心III期臨牀研究，但仍需按試驗方案和美國和/或歐洲藥品監管機構要求完成後續以及其他臨牀試驗(如有)後，方可向上述監管機構遞交相應區域內的新藥上市申請。
據國內外新藥研發經驗，新藥研發均存在一定風險，例如臨牀試驗可能會因為安全性和/或有效性等問題而終止。針對前述已開展臨牀研究的適應症及/或領域內其他適應症的臨牀試驗能否全部完成、Balixafortide及/或其相關產品/組合能否獲得美國和/或歐洲等國家和/或地區藥品監管機構最終上市批准，尚具有不確定性。
Balixafortide是Polyphor(基於由蘇黎世大學授權的專利)研發的一款強效、高選擇性CXCR4拮抗劑。CXCR4對腫瘤的生長、侵襲、血管生成、轉移和對治療藥物的耐藥性起着重要作用，CXCR4過度表達與許多癌症亞型的不良預後相關。CXCR4拮抗劑被證明可以改變腫瘤與基質的相互作用，使癌細胞對細胞毒性藥物敏感，減少腫瘤生長和轉移負擔。其作用機制包括通過調控免疫細胞遷移、減輕腫瘤浸潤、激活免疫細胞以消除腫瘤細胞，以及減少腫瘤微環境中的免疫抑制細胞。基於這些多方面的作用模式，表明CXCR4拮抗劑可以在包括化療和免疫治療在內的一系列療法中發揮積極作用。
截至公告日，Balixafortide已於美國等地區完成聯用甲磺酸艾立布林注射液針對HER2陰性轉移性乳腺癌的Ib期臨牀研究，並正在開展聯用甲磺酸艾立布林注射液治療HER2陰性轉移性乳腺癌的全球多中心III期臨牀研究。Balixafortide聯用甲磺酸艾立布林注射液已獲得美國食品藥品管理局(即美國FDA，下同)的快速通道(FastTrack)審評認證。
此次合作將進一步豐富集團產品線，有望為包括乳腺癌在內的實體瘤患者提供更多的用藥選擇，符合集團的發展戰略。
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