辰欣藥業(603367.SH)：阿司匹林腸溶片、鹽酸二甲雙胍緩釋片獲得藥品註冊批件
格隆匯9月2日丨辰欣藥業(603367.SH)公佈，近日，公司收到國家藥品監督管理總局核准簽發的阿司匹林腸溶片《藥品補充申請批准通知書》(通知書編號：2021B02688)及鹽酸二甲雙胍緩釋片《藥品註冊證書》(證書編號：2021S00853)。
阿司匹林使血小板的環氧合酶(即前列腺素合成酶)乙酰化，從而減少血栓素A2(TXA2)的生成，對TXA2誘導的血小板聚集產生不可逆的抑制作用；對ADP或腎上腺素誘導的II相聚集也有阻抑作用；並可抑制低濃度膠原、凝血酶、抗原-抗體複合物、某些病毒和細菌所致的血小板聚集和釋放反應及自發性聚集，由此預防血栓的形成。
截至目前，公司在阿司匹林腸溶片研發項目上已累計投入研發費用人民幣1416.51萬元。
根據PDB數據庫中樣本醫院數據，2020年，規格為0.1g的阿司匹林腸溶片，在售5家藥業公司銷售額總計2.62億元。
二甲雙胍直接作用於糖的代謝過程，促進糖的無氧酵解，增加肌肉、脂肪等外周組織對葡萄糖的攝取和和利用，從而保護已受損的胰島β細胞功能免受進一步損害，有利於糖尿病的長期控制。另外，可抑制腸道吸收葡萄糖，並抑制肝糖原異生，減少肝糖輸出，可使糖尿病患者血糖及糖化血紅蛋白降低。與磺酰脲類降糖藥相比，不刺激胰島素分泌，很少引起低血糖症，而兩者合用時可起到協同作用，以提高降血糖的療效。
鹽酸二甲雙胍片首選用於單純飲食及體育運動不能有效控制的 2型糖尿病，特別是肥胖的2型糖尿病。對於1型或2型糖尿病，與胰島素合用，可增加胰島素的降血糖作用，減少胰島素用量，防止低血糖發生。也可與磺酰脲類口服降糖藥合用，具協同作用。
截至目前，公司在鹽酸二甲雙胍緩釋片研發項目上已累計投入研發費用人民幣1298.48萬元。
根據2020年PDB數據庫中樣本醫院統計數據，目前規格為0.5g的鹽酸二甲雙胍片，全國八家相關醫藥公司銷售額總計4.68億元，銷量總計4.33億片。
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