遠大醫藥(00512.HK):他達拉非片獲頒發藥品註冊證書
格隆匯7月7日丨遠大醫藥(00512.HK)發佈公吿,集團自主開發的仿製藥產品他達拉非片已獲中國國家藥品監督管理局頒發藥品註冊證書。
陰莖勃起功能障礙(ED)是男性不能持續獲得和維持足夠的陰莖勃起以完成滿意性生活,是男性最常見的性功能障礙之一,既影響患者的身心健康和生活品質,同時也可能是心血管疾病的早期症狀和危險信號。根據一項對男性生活及性行為態度的跨國研(The Men's Attitudesto Life Eventsand Sexuality Study)表明,在20至75歲的人羣中,各種程度的ED的總患病率為16%,並且隨着年齡的增長,ED的發病率逐漸升高。
他達拉非是一種選擇性、可逆性的5型磷酸二酯酶(PDE5)抑制劑。中國男科疾病診斷治療指南與專家共識(2016版)中指出,口服PDE5抑制劑已成為ED治療的首選方式。相較於西地那非和伐地那非不到4個小時的半衰期,他達拉非的半衰期長達17.5個小時且有效血藥濃度可維持36小時,更適合小劑量規律性服用且耐受性良好。根據米內網的資料,2020年他達拉非市場總量為8.7億元人民幣,其中零售端佔比約88%,五年年複合增長率約為5.5%,原研藥市場份額佔比達到約89%,中國國產化產品替代潛力較大。
集團近年來一直大力拓展院外市場,加大非處方藥在電商平台和零售藥店市場的銷售合作。目前集團的銷售覆蓋了全國8000家醫院、輻射了全國12萬家零售藥店,他達拉非片的獲頒發藥品註冊證書不但可豐富集團產品管線,同時將會進一步助力集團擴張院外市場。
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