綠葉製藥(02186.HK)抗抑鬱新藥LY03005上市申請(NDA)獲美國FDA受理
格隆匯APP獲悉，綠葉製藥集團於3月4日宣佈，美國食品藥品監督管理局(FDA)對其自主研發的新化合物LY03005已完成立卷審查，並正式受理LY03005的新藥上市申請(NDA)。該藥物用於治療抑鬱症，也是綠葉製藥在美國進入NDA階段的第二個中樞神經新藥。
LY03005是基於綠葉製藥的新型化合物(NCE/NTE)平台開發的中樞神經系統獨家產品。它是一種5—羥色胺—去甲腎上腺素—多巴胺三重再攝取抑制劑(SNDRI)，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)。目前，綠葉製藥已擁有涵蓋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、日本及韓國等國家和地區獲得。
作為中樞神經領域最常見的疾病之一，全球抑鬱症的病患人數已超過3億人。該疾病是全球各地的首要致殘原因，也是導致全球疾病負擔的一個重大因素。據IQIVA數據顯示：2018年，抗抑鬱藥在美國的市場規模已達到47.4億美元，從2016年至2018年以7.3%的年複合增長率上升。
一般而言，傳統抗抑鬱藥物，如選擇性5—羥色胺再攝取抑制劑(SSRIs)、5—羥色胺—去甲腎上腺素再攝取抑制劑(SNRIs)存在快感缺乏、性功能障礙、無法改善認知障礙等藥物缺陷，而5—羥色胺—去甲腎上腺素—多巴胺三重再攝取抑制劑(SNDRIs)預計將比傳統藥物更有助於保護患者的性功能、起效更快、療效更好，有望解決目前尚未滿足的病患需求。
“包括抑鬱症在內的中樞神經疾病領域的全球患者人羣龐大且持續增加，該類疾病無論對於患者還是對其家庭都造成了嚴重困擾。我們希望提供更多優質創新的原研藥品，幫助全球更多有需要的患者。”綠葉製藥集團管理層表示。
中樞神經系統是綠葉製藥戰略佈局的核心治療領域之一。目前，公司圍繞該領域已形成一系列豐富的在研產品線，涵蓋抑鬱症、帕金森病、精神分裂症、雙相情感障礙、阿爾茨海默病等多種疾病，其中多個新藥已在美國、歐洲等國家和地區進入NDA或臨牀後期階段。公司正在全力推進這些新藥的研發及上市進程，以期進一步提升在該領域的核心競爭力和全球化運營能力。
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