三生國健(688336.SH)擬與宜明昂科合作開展賽普汀®(伊尼妥單抗)聯合IMM01臨牀研究
格隆匯4月7日丨三生國健(688336.SH)公佈，近日，公司與宜明昂科簽訂《聯合用藥開發合作協議》，合作共同推進抗HER2單克隆抗體賽普汀®(伊尼妥單抗)與抗CD47融合蛋白IMM01(以下簡稱“IMM01”)組合療法在中國的臨牀開發和商業化。該合作將由公司主導，作為研究發起者負責臨牀方案設計及臨牀運營，宜明昂科將為研究提供IMM01。該合作將針對多種HER2陽性腫瘤患者進行臨牀研究，評估伊尼妥單抗與IMM01雙藥聯用的藥物安全性，耐受性和療效。
賽普汀®(伊尼妥單抗)是中國第一個獲批上市的Fc段修飾，生產工藝優化，具有更強ADCC效應的創新抗HER2單抗，與化療藥物聯合，已被證明可以延緩HER2陽性的轉移性乳腺癌患者病情進展，並帶來生存獲益。
注射用IMM01項目是基於宜明昂科“mAb-Trap”技術平台研發的、具有自主知識產權的新一代免疫檢查點抑制劑，針對免疫調節靶點CD47，通過激活巨噬細胞對腫瘤細胞的吞噬作用，並將吞噬處理的腫瘤抗原遞呈給T細胞，從而發揮強大的腫瘤免疫治療效應。IMM01項目完美解決了CD47靶點藥物研發核心痛點，目前已分別在中國、日本和美國獲批發明專利。
IMM01與其它同一靶點藥物的最大差異化就是完全避免了與紅細胞的結合，不會引起嚴重貧血事件。同時由於糖基化修飾，大大降低了藥物的免疫原性，改善了藥物的PK，顯著提高了藥物的生物利用度。I期臨牀試驗結果初步證實了IMM01的安全性及有效性。
宜明昂科於2015年6月在中國(上海)自由貿易試驗區張江高科技園區成立，專注於抗腫瘤免疫治療產品的開發研究，主要包括雙特異性抗體、新型重組蛋白、以及TANKTM細胞治療等。這些產品的共同特徵就是通過激發調動患者自身的免疫系統來發揮抗腫瘤效應，並最終抑制腫瘤細胞的繼續生長，逆轉由此而導致的一系列惡性症狀，從而讓患者逐漸回到健康的集機體狀態。目前已有多個新型抗腫瘤藥物處於臨牀研究階段。
基於伊尼妥單抗臨牀驗證的安全性和有效性，公司正在開展多項臨牀試驗，包括和其他創新藥物的聯合應用，進一步探索和擴展伊尼妥單抗的臨牀適應症。與宜明昂科合作探索伊尼妥單抗和IMM01的聯合治療方案，能夠為患者提供更多更有效的治療選擇。
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