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康哲藥業(00867.HK)與泰諾麥博再度聯手,共同開發全人源抗新冠病毒抗體新藥等兩款創新產品
格隆匯 09-23 20:26

2021年9月23日,康哲藥業控股有限公司("康哲藥業")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")再次簽訂合作協議,就全人源抗新冠病毒抗體新藥等兩款創新產品達成合作。自今年4月以來,康哲藥業已對泰諾麥博進行股權投資並持續導入創新產品,截至目前,雙方共就4款創新產品達成合作,不斷豐富具有差異性優勢的創新管線。

根據本次協議,康哲藥業將與泰諾麥博成立新的合營公司,康哲藥業將以現金出資,泰諾麥博以兩款合作產品相關技術的全球權益作為無形資產出資,雙方將分別持有合營公司50%的權益,康哲藥業將負責產品後續的臨牀開發以及在中國大陸、香港特別行政區、澳門特別行政區和台灣("大中華地區")的商業化工作,並擁有在大中華地區外同等條件下的優先合作權。雙方將充分發揮自身在創新產業鏈中的核心優勢,加速推動創新藥從發現、臨牀前研究、臨牀開發到商業化全進程。

此次合作的兩款創新產品均基於泰諾麥博專有技術平台HitmAb®開發,該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。

關於全人源抗新冠病毒抗體新藥

全人源抗新冠病毒抗體新藥是一款針對新冠病毒感染的天然全人源抗體,其可直接中和體內新冠病毒,且中和抗體的"雞尾酒"療法有望用於預防和治療新冠病毒感染,現處於臨牀前研究階段。

目前,新型冠狀病毒仍在全球流行,已獲批的相關疫苗尚無法起到絕對的人羣保護效果,且全球尚無特效治療藥問世。中和抗體作為一種有抗病毒活性的單抗,具有特異性和高親和力,能搶先與新冠病毒表面的刺突蛋白(S蛋白)受體結構域(RBD)結合,從而阻斷病毒與宿主細胞結合,使病毒無法感染細胞,繼而被免疫系統清除。多篇報道指出,抗新冠病毒中和抗體用於治療和預防新冠病毒感染有一定可行性,有望與新冠疫苗互為補充。同時,新冠中和抗體"雞尾酒"療法通過組合兩種或兩種以上針對不同新冠病毒表位的單克隆抗體,提供不同中和活性的疊加,較單組分抗體,可預防耐藥毒株的產生,覆蓋更廣泛人羣。

全人源抗新冠病毒抗體的臨牀前數據顯示,其對目前主要流行株(包括南非株和印度株)均有效,且天然全人源單抗具有良好的安全性。面對新型變異毒株可能導致的大流行,本品有望進一步滿足全球新冠病毒感染的預防及治療需求。

未來,康哲藥業與泰諾麥博將繼續友好協商,促成更多天然全人源單抗藥物的優先合作,加速產品在中國的落地,為廣大患者提供有效性安全性俱佳的創新藥物選擇。

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