香雪製藥(300147.SZ):本次TAEST16001注射液被納入突破性治療品種名單不會對公司2024年度業績產生重大影響
格隆匯8月6日丨香雪製藥(300147.SZ)公佈股票交易異常波動暨嚴重異常波動公吿,公司子公司TAEST16001注射液被國家藥品監督管理局藥品審評中心納入突破性治療品種名單,並不代表能獲批上市,也不會對公司2024年度業績產生重大影響。TAEST16001注射液的研發具有高科技、高風險、高附加值的特點,研發週期長、投入大,研發過程中不可預測因素較多,且容易受到技術、審批、政策等多方面因素的影響。根據《藥品註冊管理辦法》等法規的相關規定,新藥註冊一般需經過臨牀前基礎工作、臨牀研究審批、生產審批等階段,存在較大的不確定性,如果最終未能通過新藥註冊審批,致使研發失敗,公司前期研發投入將無法回收。此外,如公司推出的新藥產品不能適合市場需求或在市場推廣方面出現較大阻礙,無法實現產品規模化生產銷售,則將對公司盈利水平和未來發展產生不利的影響。
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