綠葉製藥(02186.HK)：LY 03005在抑鬱症患者身上展現出良好的療效及安全性
格隆匯6月8日丨綠葉製藥(02186.HK)發佈公吿，集團自主研發的中國1類化學新藥(LY 03005)的III期臨牀結果於2022年美國精神病學協會（American Psychiatric Association,APA）年會上發佈。
APA是全球最大的精神病學協會，其年會為每年精神科領域的頂級學術研究會議之一，聚焦於精神病學的突破性研究、臨牀進展及該領域內的熱點話題。此次LY 03005的III期臨牀數據亮相APA年會，彰顯其作為中國原創1類新藥對於抑鬱症治療的作用與意義，在獲得國際學術認可的路上邁出重要一步。
LY 03005是一種全新作用機制的新分子實體治療藥物，已在中國完成I期至III期治療抑鬱症的臨牀試驗，處於上市審評階段。作為一種5-羥色胺（5-HT）、去甲腎上腺素(NE)和多巴胺(DA)三重再攝取抑制劑，LY 03005能夠全面而且穩定的改善抑鬱症狀，快速改善焦慮狀態，明顯改善快感缺失和認知功能，而且不引起嗜睡、不影響性功能、體重和脂代謝，特別是能夠更好的促進抑鬱症患者社會功能的恢復。
此次APA年會上展示的III期臨牀試驗為一項多中心、隨機、雙盲、安慰劑對照研究，評估LY 03005治療抑鬱症的療效和安全性。研究共納入558例抑鬱症患者，隨機分配為3組，並接受LY 03005（80mg和160mg）或安慰劑治療，為期8周。研究結果顯示：LY 03005在抑鬱症患者身上展現出良好的療效及安全性，可全面改善抑鬱症狀。
亞利桑那性體驗量表(ASEX)評分結果顯示：在性功能影響方面，LY 03005與安慰劑無統計學差異；在體重方面，80mg和160mg劑量組的受試者體重較基線略有下降，安慰劑組較基線無明顯變化；此外，兩個劑量組的嗜睡不良反應僅為1.63%，與其他抗抑鬱藥相比更低；失眠發生率與安慰劑組相似。
據悉，抑鬱症是一種全球常見疾病，根據世界衞生組織數據，全球有超過3.5億人罹患該病，這種疾病為患者帶來痛苦和困難，尤其令其於社交生活中受苦。抑鬱症在中國的發病率估計約為4.2%。根據IQVIA資料，抗抑鬱藥在2020年於中國市場規模達到63.1億元人民幣。
除中國外，LY 03005也在美國處於上市審評階段，並在日本完成I期臨牀試驗，用於治療抑鬱症。此外，該藥物用於治療廣泛性焦慮障礙的III期臨牀試驗也在中國獲准進行。更多臨牀研究的開展將助力LY 03005的治療潛力得到進一步挖掘，有望為患者及其家庭帶來新的治療選擇和希望。
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