綠葉製藥(02186.HK)：美國食品藥品監督管理局受理LY03005新藥申請
格隆匯3月4日丨綠葉製藥(02186.HK)發佈公告，美國食品藥品監督管理局（FDA）已經完成立卷審查並決定受理本集團抑鬱症（Major Depressive Disorder）新藥LY03005的新藥申請，此申請是根據聯邦食品、藥品和化粧品法案的第505(b)(2)條及聯邦規則彙編第21章§314.50。
LY03005是一種5–羥色胺–去甲腎上腺素–多巴胺三重再攝取抑制劑(SNDRI)，而其中的一個活性代謝產物是一種5–羥色胺–去甲腎上腺素雙重再攝取抑制劑(SNRI)。LY03005是一項基於集團的NCE/NTE平台開發的中樞神經系統獨家產品，用於治療抑鬱症。集團已擁有涵蓋LY03005化學成份、晶體形態及製劑的專利。化學成份及晶體形態的專利已在中國、美國、歐洲、日本及韓國等目標市場取得。
選擇性5-羥色胺再攝取抑制劑(SSRIs)及5-羥色胺-去甲腎上腺素再攝取抑制劑(SNRIs)等傳統抗抑鬱藥物一般會有一些缺陷，比如快感缺乏症、性功能障礙及無法改善認知障礙等，而SNDRIs預計比傳統抗抑鬱藥物更有助於保護患者的性功能、起效更快以及療效更好。根據IQIVA資料，抗抑鬱藥在2018年於美國市場規模達到47.4億美金，從2016年至2018年以7.3%的年複合增長率上升。
除LY03005外，集團還有多箇中樞神經系統的在研項目，同步在中國及海外市場進行開發，如已向美國FDA提交NDA並通過PAI批准前檢查的LY03004（關於精神分裂症和雙向情感障礙）、LY03003（關於帕金森氏症）、LY03010（關於精神分裂症和分裂情感性障礙的治療）、LY30410（關於中輕度阿茲海默症）和LY03012（關於慢性疼痛）等項目。上述在研產品在中國、美國、歐洲和日本等戰略市場註冊進展良好，未來將在這些國家上市並進一步擴展到全球市場。
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