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悦康藥業(688658.SH):枸櫞酸愛地那非片獲批上市
格隆匯 12-29 14:24

格隆匯12月29日丨悦康藥業(688658.SH)公佈,公司研發的1.1類新藥枸櫞酸愛地那非片,於2021年12月29日取得國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品註冊證書》(證書編號:2021S01288)。

枸櫞酸愛地那非片為公司研發1.1類新藥用於治療男性勃起功能障礙(Erectile DysfunctionED),其通過抑制磷酸二酯酶5(PDE5)水解cGMP發揮作用。在性刺激時,陰莖海綿體血管內皮細胞一氧化氮合成酶(NOS)催化 L-精氨酸合成一氧化氮(NO),後者激活鳥苷酸環化酶使環磷酸鳥苷(cGMP)合成增加,繼而引起陰莖海綿體平滑肌和陰莖小動脈平滑肌的鬆弛,血液注入陰莖海綿竇,使陰莖勃起。本品可在NO存在時舒張海綿體平滑肌,對於勃起指數和海綿體腔內壓有改善作用。

根據米內網數據庫2020中國城市公立醫院、縣級公立醫院(簡稱中國公立醫療機構)及中國城市實體藥店零售終端數據顯示,國內主要抗ED化學為枸櫞酸西地那非片、他達拉非片、鹽酸伐地那非片等產品,2020年市場規模為35.67

截止202111月,公司枸櫞酸愛地那非片及原料藥累計研發投入為7628.3萬元(2021數據未經審計)

枸櫞酸愛地那非的獲批上市標誌着公司具備了在國內市場銷售該產品的資格,豐富了公司的產品線,有助於提升公司產品的市場競爭力,對公司經營發展具有積極作用。

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