辰欣藥業(603367.SH)：磷酸西格列汀片、克林黴素磷酸酯注射液獲得藥品註冊批件
格隆匯11月9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磷酸西格列汀片《藥品註冊證書》(證書編號：2021S01027)及克林黴素磷酸酯注射液《藥品補充申請批准通知書》(通知書編號：2021B03783)。
西格列汀是一種有效和高度選擇性的二肽基肽酶4(DPP-4)抑制劑，在2型糖尿病患者中可通過增加活性腸促胰島激素的水平而改善血糖控制。西格列汀能夠防止DPP-4水解腸促胰島激素，從而提高血漿中胰升糖素樣肽-1(GLP-1)和糖依賴性促胰島素釋放肽(GIP)活性，並且在發揮降糖作用同時不會引起因GLP-1含量過高而產生的噁心、嘔吐等副作用。通過增加活性腸促胰島激素水平，西格列汀以葡萄糖依賴的方式增加胰島素釋放並降低胰高糖素水平，故能大大降低口服降糖藥低血糖的發生率。
使用磷酸西格列汀片單藥治療時，配合飲食控制和運動，可用於改善2型糖尿病患者的血糖控制。當單獨使用鹽酸二甲雙胍血糖控制不佳時，磷酸西格列汀可與鹽酸二甲雙胍聯合使用，在飲食和運動基礎上可以改善2型糖尿病患者的血糖控制。除此之外，還可以與磺脲類藥物或胰島素聯用，在配合飲食控制和運動基礎上，可用於改善經上述單藥治療或聯合二甲雙胍治療後血糖控制不佳的2型糖尿病患者的血糖控制。
截至目前，公司在磷酸西格列汀片研發項目上已累計投入研發費用為人民幣1713.99萬元。
克林黴素通過與核糖體50S亞基的23SRNA結合來抑制細菌蛋白質合成。克林黴素磷酸酯注射液主要適用於由敏感厭氧菌、鏈球菌、肺炎球菌和葡萄球菌敏感菌株引起的感染性疾病。
敏感菌引起的感染性疾病，包括：下呼吸道感染，包括厭氧菌、肺炎鏈球菌、其他鏈球菌(糞腸球菌除外)和金黃色葡萄球菌引起的肺炎、膿胸和肺膿腫；由化膿性鏈球菌、金黃色葡萄球菌和厭氧菌引起的皮膚和皮膚結構感染；敏感厭氧菌引起的婦科感染，包括子宮內膜炎、非淋球菌性輸卵管卵巢膿腫、盆腔蜂窩織炎和術後陰道袖帶感染；敏感厭氧菌引起的腹腔內感染，包括腹膜炎和腹內膿腫；由金黃色葡萄球菌、鏈球菌(除腸球菌)和敏感厭氧菌引起的敗血症；金黃色葡萄球菌引起的包括急性血源性骨髓炎在內的骨和關節感染，作為敏感微生物引起的慢性骨和關節感染的手術治療的輔助治療。
截至目前，公司在克林黴素磷酸酯注射液研發項目上已累計投入研發費用為人民幣732.04萬元。
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