天士力(600535.SH):抑鬱症治療藥獲藥物臨牀試驗批准通知書
格隆匯8月5日丨天士力(600535.SH)公佈,日前,公司收到國家藥監局核准簽發用於治療抑鬱症的化學藥品1類新藥JS1-1-01片《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。
JS1-1-01是一種全新結構的5-羥色胺–去甲腎上腺素–多巴胺三重再攝取抑制劑(SNDRIs),同時還可促進腦源性神經營養因子(BDNF)的分泌,從而發揮抗抑鬱作用。臨牀前研究數據證實,JS1-1-01片在療效和起效時間上優於傳統的抗抑鬱藥物,且安全性好。公司已擁有涵蓋JS1-1-01化合物、工藝、適應症及製劑的專利,其化合物專利已在中國、歐洲、美國、日本、韓國、澳大利亞等目標市場取得。全球尚未有同機製藥物獲批上市,研發進展最快的同類藥物處於臨牀Ⅱ/Ⅲ期階段。產品研發成功上市後,能為中國乃至全球抑鬱症患者帶來更多的選擇和希望。截至本公告日,公司對該項目的累計研發投入為人民幣2241.35萬元。
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