俄烏局勢如何影響製藥和生物技術的研發
因俄烏的地緣政治問題的持續存在,一些在這兩個國家進行臨牀試驗的製藥和生物技術公司,都受到一定程度的影響。
生物技術公司Karuna Therapeutics(KRTX)表示,此次騷亂已經影響了一項後期試驗。週四,該公司表示,預計今年下半年KarXT用於精神分裂症的emergency -3試驗的總數據可能不會公佈。該研究正在美國和烏克蘭進行。
傑富瑞(Jefferies)分析師克裏斯•霍爾頓(Chris Howerton)指出,如果emergen -2試驗(該試驗僅在美國開展)的數據在年中左右表現積極,在烏克蘭的試驗中出現的任何延誤可能不會像人們擔心的那樣產生重大影響。
Howerton補充說,他跟蹤的其他幾家小型生物技術公司也都與烏克蘭有一些關聯:Applied Molecular Transport (AMTI)、Intra-Cellular Therapies (ITCI)、TG Therapeutics (TGTX)和Veru (Veru)。
例如,Veru (Veru)有一個評估enobosarm在乳腺癌中的療效的3期試驗。除美國外約三分之一的試驗地點都在烏克蘭。然而,Howerton寫道,由於試驗最近纔開始,公司可以做出調整,滿足時間進度表。
細胞內治療(ITCI)已經進行了抗精神病藥物Caplyta (lumateperone)的3期研究,以作爲雙相抑鬱症和重度抑鬱症的單藥治療。42個試驗點中有7個在烏克蘭,另外8個在俄羅斯。
還有一些大型的製藥和生物技術公司也在俄羅斯和烏克蘭開展研發工作,如百健(BIIB)、因賽特(INCY)和禮來(LLY):百健(BIIB)在俄羅斯的一些地點進行了幾個三期臨牀試驗,其中包括阿爾茨海默病藥物lecanemab;因賽特(INCY)在這兩個國家都有兩個PD-L1項目。口服PD-1抑制劑的II期研究最易受影響,因爲70%的試驗地點在烏克蘭;禮來(LLY)的Oluminant (baricitinib) 在其他幾個適應症中的試驗涉及到這兩個國家。但因與因賽特 (INCY) 在藥物上的合作可能會緩衝禮來公司所遇到的風險。
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