君實生物(01877.HK)：暫停供應雙抗體療法並非撤回其在美國的緊急使用授權
格隆匯6月28日丨君實生物(01877.HK)發佈公吿，公司關注到有媒體報道，埃特司韋單抗(etesevimab，JS016) 1,400mg和巴尼韋單抗(bamlanivimab，LY-CoV555) 700mg雙抗體療法(“雙抗體療法”)在美國被停止分發。公司對報道內容進行了核實，現就主要情況作澄清説明如下：
美國疾控中心(CDC)近日監測到SARS-CoV-2的P.1/Gamma突變型(最先於巴西確認)及B.1.351/Beta突變型(最先於南非確認)在美國的總比例已超過11%並呈上升趨勢，美國政府相關部門於當地時間2021年6月25日宣佈在美國暫停供應雙抗體療法直至另行通知。
上述暫停供應雙抗體療法並非撤回其在美國的緊急使用授權(EUA)。根據2021年6月刊登在國際權威學術期刊《細胞》(CELL)的論文Tackling COVID-19 with neutralizing monoclonal antibodies顯示，雙抗體療法針對B.1.1.7/Alpha突變型(最早於英國確認，目前佔美國的SARS-CoV-2比例約60%)及B.1.617.1突變型(最早於印度確認)均有效。過去數月內美國各地區SARS-CoV-2各突變類型所佔比例變化較快，未來雙抗體療法仍有可能在美國恢復使用。公司合作伙伴美國禮來公司將繼續在除大中華地區外的其他區域與監管機構持續溝通，確保適當的患者可獲得雙抗體療法治療。
公吿表示，雙抗體療法的供應與美國疫情的發展及相關監管部門的審批相關，其後續變化存在高度不確定性，對公司未來業績影響亦具有不確定性。醫藥產品具有高科技、高風險、高附加值的特點，藥品的前期研發以及產品從研製、臨牀試驗報批到投產的週期長、環節多，容易受到一些不確定性因素的影響。敬請廣大投資者謹慎決策，注一錮範投資風險。公司將積極推進上述研發項目，並嚴格按照有關規定及時對項目後續進展情況履行信息披露義務。
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