康哲藥業(00867.HK)與泰諾麥博就第二個創新產品達成合作
2021年6月21日，康哲藥業控股有限公司("康哲藥業"或"公司"，股份代號：867.HK)與創新型生物製藥公司珠海泰諾麥博生物技術有限公司("泰諾麥博")簽訂補充協議，泰諾麥博將第二個創新產品---全人源抗人鉅細胞病毒單抗新藥相關技術的中國大陸、香港特別行政區、澳門特別行政區及台灣權益作為無形資產注入公司與泰諾麥博將成立的合營公司。此次合作將進一步豐富康哲藥業創新藥物組合，加固創新能力護城河。
今年4月，康哲藥業宣佈將對泰諾麥博進行股權投資並與其成立合營公司，開啟公司對創新型生物科技公司產業化投資新模型，泰諾麥博的天然全人源單抗研發技術平台與康哲藥業的臨牀開發和商業化能力將形成優勢互補，實現創新能力與商業化實力的強強聯合，加速創新藥物從發現、臨牀開發到商業化的進程。
全人源抗人鉅細胞病毒單抗新藥
全人源抗人鉅細胞病毒(HCMV)單抗新藥基於泰諾麥博HitmAb®平台開發，現處於臨牀前研究階段。HitmAb?平台開發的天然全人源單克隆抗體最大特點是安全性高，對外來病原體具有廣譜性，與病原靶點具有極強的親和力，並能解決過往傳統抗體藥物的抗藥抗體反應難題。
HCMV感染在人羣中十分普遍，國內研究表明中國成年人羣HCMV血清學陽性率為97%以上；對於新生兒、器官移植接受者等機體免疫水平較低的人羣，HCMV感染有可能會造成嚴重的病理損傷。至今，國內外尚無HCMV疫苗上市，僅有少數抗病毒藥被批准用於治療HCMV感染，這些藥物作用靶點單一、抗病毒活性一般、生物利用度差、易產生耐藥性且具有較嚴重的不良反應；另有血液製品如靜脈注射用免疫球蛋白(IVIG)和HCMV特異性免疫球蛋白(IgG，國內未上市)被批准用於部分器官移植受者的HCMV輔助性預防，但使用人羣受限，可及性差。
全人源抗HCMV單抗新藥作用機制明確、安全性高，且非血製品，可在嚴格質量控制下進行規模化生產，提升藥物可及性。未來一旦上市，該產品有望填補國內外HCMV單抗的空白，為患者帶來有效、安全的預防性治療手段。
除已合作的2個產品外，康哲藥業將與泰諾麥博進一步友好協商並促成雙方就特定產品的優先合作，推動有效性安全性俱佳的天然全人源單克隆抗體藥物在中國上市，惠及更多患者。
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