李氏大藥廠(00950.HK)：癌痛藥的臨牀試驗申請獲批准
格隆匯 11 月 6日丨李氏大藥廠(00950.HK)公佈，有關公司全資附屬公司李氏大藥廠(香港)有限公司("李氏香港")所作出有關用於治療爆發性癌痛的Staccato®芬太尼吸入製劑的臨牀試驗新藥申請。
李氏香港已於2020年11月2日獲得中國國家藥品監督管理局批准進行該臨牀試驗。集團在2018年3月從Alexza引進Staccato®芬太尼吸入製劑。美國早前進行的一項一期臨牀研究顯示，單次吸入芬太尼與靜脈注射芬太尼的藥物代謝動力學特性相若。Staccato®芬太尼吸入製劑是一種複合型吸入式給藥裝置，其設計是透過肺部迅速及規律地吸入霧化芬太尼。此項產品結合具有獨特給藥技術的最新科技，於確保藥效的同時防止濫用及過量用藥。
集團已在南沙廠房內建立Staccato®芬太尼的新生產設施。Staccato®芬太尼的生產設施涉及複雜的薄塗層工藝及精確控制，將不鏽鋼底座切下及焊接到位，並將芬太尼藥物塗在底座上以完成藥物盒的組裝。由於Staccato®芬太尼是藥物裝置的組合，因此裝置部件在內部組裝及測試。該裝置將使Staccato®芬太尼成為唯一內置真正的防止濫用及過量用藥功能的鴉片類藥物。
即將於中國進行的一╱二a期多中心研究專門評估Staccato®芬太尼在治療癌症病患的爆發性癌痛的藥效及安全程度。研究將分為兩個階段：第一階段研究專責釐定建議劑量；而第二階段研究將基於第一階段能夠紓緩病患痛楚的建議劑量，進行藥物代謝動力學研究。集團預期於2021年初開展此項Staccato®芬太尼的第一╱二a期臨牀試驗。
根據GLOBOCAN資料庫，中國於2018年估計新增430萬宗癌症病例，意味着在治療爆發性癌痛方面存在大量未得到滿足的醫療需求，需要一種速效芬太尼藥劑，以便有效治療管理爆發性癌痛，填補中國未得到滿足的需求
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