天士力(600535.SH)：擬引進一款治療胰腺癌及黑色素瘤的溶瘤病毒產品
格隆匯5月11日丨天士力(600535.SH)公佈，公司控股子公司天士力生物醫藥股份有限公司(“天士力生物”)於近日與 Takara Bio Inc.(日本寶生物工程株式會社，東京證券交易所上市公司，股票代碼：4974.T,“寶生物”或“Takara”)簽署了《C-REV許可協議》，天士力生物引進一款治療胰腺癌及黑色素瘤的溶瘤病毒產品(“C-REV”)。該藥物治療胰腺癌的日本一期臨牀的中期數據已發佈，治療黑色素瘤的二期臨牀試驗已完成。根據協議約定，天士力生物擁有在中國(包括中國大陸、香港及澳門，不包括台灣，“合作區域”)排他性的開發、註冊、生產和商業化的權益。該創新藥物的引進，將進一步拓寬天士力生物腫瘤治療藥物產品管線，有利於天士力生物搭建溶瘤病毒技術平台。
C-REV為Takara研發並擁有全球知識產權，是1型單純皰疹病毒(HSV-1)減毒菌株，可在腫瘤細胞中選擇性複製並分解腫瘤細胞，而不會損壞正常細胞。
目前C-REV開發的適應症包括胰腺癌和黑色素瘤。2019年底披露的治療胰腺癌的日本一期臨牀的中期數據顯示，針對不能手術的初治胰腺癌患者和吉西他濱難治的IV期胰腺癌患者，C-REV給藥方案的療效顯著優於上市藥物，在在研藥物中處於領先地位，安全耐受性良好；2018年在美國和日本完成的兩項黑色素瘤二期臨牀研究結果證實了C-REV對腫瘤的治療作用和良好的安全性。
Takara是一家創新型生物技術公司，成立於2002年，已發行股本為149.66億日元，註冊地為日本滋賀縣草津市。Takara主要從事生物產業業務和基因治療業務。其中生物產業業務包括：1)研究試劑、科學儀器出售；2)各種CDMO服務，包括病毒載體生產、iPS合同生產、細胞工藝開發及製備等。基因治療業務包括開發和商業化治療癌症等的基因治療產品。
Takara將該藥物的相關知識產權、專利權、C-REV商標有償許可給天士力生物。天士力生物獲得該藥物在合作區域內開發、註冊、生產和商業化的不可撤銷和排他性的權益及依照開發計劃在合作區域內獲得批准之需，在北美和歐洲國家進行臨牀試驗的不可撤銷和非排他性權益。根據協議，天士力生物須向Takara支付的首付款及里程碑付款總額最高為2750萬美元。
腫瘤領域為天士力生物專注的三大治療領域之一。該創新藥物的引進，將進一步拓寬了天士力生物腫瘤治療藥物產品管線，並可與其在研消化道腫瘤產品安美木單抗SY101和重組溶瘤痘苗病毒注射液T601形成戰略匹配和資源共享，有利於天士力生物搭建溶瘤病毒技術平台。
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