華森製藥(002907.SZ):痛瀉寧顆粒獲得新加坡註冊批文
格隆匯5月29日丨華森製藥(002907.SZ)公佈,公司於近日收到新加坡衞生科學局(Health Sciences Authority)(以下簡稱“HSA”)核准簽發的中成藥註冊批文,批准公司重點中成藥痛瀉寧顆粒符合新加坡中成藥標準註冊,並批准其在新加坡上市銷售。
痛瀉寧顆粒源於經典名方(“痛瀉要方”),為全球首個治療IBS-D的天然植物藥。該藥物具有“疏肝理脾,痛瀉併除”的功效,能夠通過多環節和多靶點對IBS進行治療,且療效顯著、安全性高,並能有效預防復發。其適應症為柔肝緩急、疏肝行氣、理脾運濕,適用於因肝氣犯脾所引起的腹痛、腹瀉、腹脹、腹部不適等症狀,以及腸易激綜合徵(腹瀉型)等具有上述證候者。該產品為全國重點品種、國家重大新藥創制項目成果、國家專利品種,榮獲國家科技部“火炬計劃”項目,並被納入《國家醫保目錄》、《中國藥典》(2020年版),是2017年度最具市場潛力胃腸疾病用藥金磚品種,得到十四項指南共識推薦用藥,並榮獲中華中醫藥學會科學技術一等獎、中國專利優秀獎。
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