綠葉製藥(02186.HK)治療抑鬱症新藥鹽酸安舒法辛緩釋片於日本開始I期臨牀試驗
格隆匯12月12日丨綠葉製藥(02186.HK)公佈，鹽酸安舒法辛緩釋片（LY03005），用於治療重度抑鬱症的化學新藥，已於日本開始I期臨牀試驗。
LY03005是一項基於新型化合物平台開發的中樞神經系統在研產品，該藥物是以緩釋片形式製備的獨家鹽酸安舒法辛產品（一種5–羥色胺–去甲腎上腺素–多巴胺三重再攝取抑制劑(SNDRI)），用於治療抑鬱症。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LY03005預計比傳統抗抑鬱藥物更有助於保護患者的性功能，安全性更高，起效更快，療效更好。
該集團已擁有涵蓋緩釋片化學成份、晶體形態及製備的專利。化學成份及晶體形態的專利已在中國、美國、歐洲、日本及韓國等目標國家╱地區取得。本集團計劃在美國、日本、中國、歐洲及其他國家╱地區註冊和於市場推出LY03005。除日本外，LY03005正在中國進行三期臨牀試驗，在美國進行系列臨牀試驗。
據悉，抑鬱症是一種全球常見疾病，根據世界衞生組織資料，全球有超過3億人罹患該病，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。2018年抗抑鬱藥物在日本國家醫療保險(NHI)中的銷售金額約為1,570億日元（約為14.5億美元），從2016年至2018年以9.9%的年複合增長率上升。
公司稱，除LY03005外，該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，如注射用利培酮緩釋微球Rykindo（LY03004，關於精神分裂症和雙向情感障礙）、微球製劑注射用羅替戈汀緩釋微球LY03003（關於帕金森氏症）、帕利呱酮緩釋混懸肌肉注射劑LY03010（關於精神分裂症和分裂情感性障礙的治療）及卡巴拉汀透皮多日貼劑LY30410（關於中輕度阿茲海默症）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，預計未來將在這些國家市場推出並進一步擴展到全球市場。
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