復星醫藥(600196.SH)：復宏漢霖擬合作開發治療新冠肺炎的全人源抗體藥物
格隆匯5月6日丨復星醫藥(600196.SH)公佈，2020年5月6日，公司控股子公司復宏漢霖與三優生物、之江生物(三優生物及之江生物合稱“合作方”)就合作開發全人源抗體藥物用於單藥或聯用治療新冠肺炎簽訂《合作開發協議》。本次合作中，合作方負責提供候選抗體，主導完成經病毒中和活性驗證的全人源抗體藥物優選分子的PCT國際專利申請並保證進入PCT國家階段，負責相關中國發明專利申請及申請後的維護；在合作方的協助下，復宏漢霖負責主導完成該新藥的細胞株及細胞庫構建、藥理藥代、藥效學評價、藥物處方及工藝研究、中試生產及檢驗、質量研究、安全性評價，以及根據協商一致的新藥臨牀試驗申報策略和市場需求，在中國和/或其他國家、地區完成新藥臨牀試驗申報，並承擔相應的成本和費用。根據約定，復宏漢霖將就本次合作支付簽約金人民幣200萬元(以下簡稱“對價”)；該新藥商業化應用產生的利潤或許可/轉讓所獲收益等，將由復宏漢霖與合作方分享。
抗體藥物能夠特異性地識別病原體並與之結合，進而通過機體自身免疫系統的作用清除病原體，通常具有特異性高、安全性好、血清半衰期長等特性。其中：全人源抗體藥物具有100%人源氨基酸序列，與嵌合抗體或人源化抗體相比，具有更低的免疫原性和更好的安全性。
用於該新藥研發的具有優異抗病毒活性且對細胞無毒性的優選分子由合作方依託全人源抗體庫等技術平台篩選並負責提供。候選抗體為全人源單克隆抗體，從機理上能夠中和新冠肺炎病毒，能夠特異性識別SARS-CoV-2病毒spike蛋白受體結合結構域(RBD)，阻斷其與人ACE2受體的結合，從而抑制病毒活性。截至本公告日，該新藥已完成抗體的早期篩選、細胞水平初步活性檢測、體外活病毒中和活性檢測、初步成藥性分析和抗體細胞株克隆初篩工作，尚處於臨牀前研究階段。
截至本公告日，全球範圍內尚無用於治療新冠肺炎的全人源抗體藥物獲得上市批准。參與新冠病毒抗體藥物的開發有利於進一步豐富集團產品線，預計本次合作對本集團2020年的營業收入、淨利潤不會產生重大影響。
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