冠昊生物(300238.SZ)：聯合美國參股公司擬開展新型肺炎冠狀病毒疫苗研究
格隆匯2月3日丨冠昊生物(300238.SZ)公佈，公司與美國的參股公司ZY Therapeutics Inc.(以下簡稱“ZY公司)擬開展新型肺炎冠狀病毒mRNA疫苗(Z-VacciRNA)的研究工作。
ZY公司於2015年9月15日設立，是一家生物醫藥技術公司，公司註冊地位於美國北卡羅萊納州。2019年9月公司以股權投資方式取得ZY公司31%的股權，為第一大股東。
ZY公司擬開發的新型聚合物納米藥物遞送平台技術可批量生產具有靶向性的、可生物降解、無毒性的核酸遞送聚合物(ZY-030)。該聚合物與選擇性mRNA藥物經過製劑加工後，可以幫助mRNA靶向輸送到樹突狀細胞中，使得mRNA在樹突狀細胞中表達出相關的抗原，產生人體的免疫反應來預防新型肺炎冠狀病毒。該製劑最終有望做成穩定性好的凍乾粉針劑供皮下注射成為新型冠狀病毒的疫苗。
本項目計劃針對已經公開的新型冠狀病毒基因組序列，篩選出數條可有特異性的病毒蛋白mRNA候選藥物；然後利用ZY的藥物傳輸技術將這些候選mRNA藥物做成凍乾粉針劑，通過體外和體內實驗確定1-2個候選藥物後，由ZY做成製劑開展臨牀前毒性研究，最後在中國申報藥監管理部門開展臨牀實驗，並最終在中國生產和銷售。
ZY主要科研人員(於2010年)成功發明LCP(Lipid Calcium Phosphate)納米包裹技術，經研究證明，mRNA包裹成納米顆粒後，經皮下注射後可以增強和延長mRNA沉積到淋巴結，其中的樹突狀細胞(DC)是吸收包裹了mRNA的納米顆粒的主要種羣。在注射mRNA編碼的Trp2抗原後小鼠中，觀察到非常強的抗原特異性細胞毒性T淋巴細胞(CTL)。預計如果選擇合適的病毒特異性蛋白mRNA被遞送到淋巴結，DC細胞就能表達相關的抗原，引起機體的免疫反應，從而避免被新型冠狀病毒感染。
公司表示，新藥研製具有高風險、高投入、週期長的特性。項目處於研發早期階段，易受到技術、新藥申報與審批、行業政策等多方面不可預測因素的影響，最終能否成功獲批上市存在一定的不確定性和風險性，敬請廣大投資者注意投資風險。
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