科倫藥業(002422.SZ)：預計3月初可實現洛匹那韋/利托那韋片批量生產
格隆匯2月17日丨科倫藥業(002422.SZ)公佈，公司子公司四川科倫藥物研究院有限公司自1月21日成立抗新型病毒藥物研究攻關小組以來，全力推進涵蓋預防及治療作用的1個創新多肽藥物和3個仿製藥物的研究。
(一)預防用抗新型病毒創新多肽及吸入製劑
1．研製背景：在已獲知新型冠狀病毒序列的基礎上，設計特異性針對病毒S蛋白和宿主細胞表面受體ACE2的新型多肽，阻斷病毒與細胞的吸附和融合，達到預防新型病毒感染目的。
2．研製進展：公司利用已擁有的計算機輔助設計、多肽藥物研究能力和吸入製劑研發平台已完成20條多肽的設計與合成；通過體外活性篩選與靈長類動物安全性評價，已獲得4條具有良好生物學活性和安全性的多肽候選分子；其中1條多肽已完成放大生產，並獲得放大製劑樣品；目前正在全力推進包括人體安全性試驗在內的後續研究，以期儘快為一線醫護人員、政府防疫機構、基層高危工作人員等提供有效的預防用藥。
(二)抗新型病毒仿製藥
1．洛匹那韋/利托那韋片在衞健委制定的第一版到第五版《新型冠狀病毒感染的肺炎診療方案》中洛匹那韋/利托那韋片被推薦可用於新型冠狀病毒感染的治療。
公司利用在熱熔擠出平台領域的技術優勢，現已完成洛匹那韋/利托那韋片的製劑處方工藝開發研究，進入到生產線規模化試製階段，預計3月初可實現本品批量生產；可在需要時，快速捐贈疫區。
2．奧司他韋膠囊奧司他韋是衞健委建議治療流行性感冒的一線治療方案，且目前已有個別新型冠狀病毒感染臨牀病例聯合使用奧司他韋與洛匹那韋/利托那韋后證實有效。目前，公司已通過人體生物等效研究並有多批次批量生產樣品，可在需要時，快速捐贈疫區。
此外，公司利用在複雜原料藥和注射劑開發領域的技術優勢，還成功仿製開發了一項抗新冠病毒藥物的原料藥，製劑研究已確定處方工藝；預計3月中旬可實現該仿製藥物的批量生產能力；可在需要時，快速捐贈疫區。
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