信立泰(002294.SZ)：SAL0112片臨牀試驗申請獲得受理
格隆匯5月30日丨信立泰(002294.SZ)公佈，近日，公司收到國家藥品監督管理局核准簽發的受理通知書，公司自主研發的創新小分子化學藥物SAL0112片臨牀試驗申請獲得受理。
SAL0112片為胰高血糖素樣肽-1受體(GLP-1R)的口服小分子偏向激動劑，擬開發適應症包括2型糖尿病(T2DM)。
激動GLP-1R可以促進胰島β細胞的增殖，血糖依賴型刺激胰島素的合成與釋放，並抑制胰高血糖素的合成與釋放，低血糖風險較低；可以抑制胃液分泌和胃腸道的蠕動，延遲胃的排空，增加飽食感，減少食物攝取。此外，激動GLP-1R可以提升心血管的功能，抑制心肌細胞的凋亡，可以抑制腎臟的氧化應激和炎症反應，抑制糖基化終產物等，從而產生保護腎臟的作用，因此，GLP-1R激動劑可應用於2型糖尿病和肥胖，同時伴有心腎的獲益。
中國2型糖尿病防治指南(2020年版)指出，合併動脈粥樣硬化性心血管疾病(ASCVD)或心血管風險高危T2DM患者，不論其HbA1c是否達標，只要沒有禁忌證都可在二甲雙胍的基礎上加用具有ASCVD獲益證據的GLP-1R激動劑。在《改善心血管和腎臟結局的新型抗高血糖藥物臨牀應用中國專家建議》的共識中指出，GLP-1RA治療T2DM合併ASCVD確診或高危患者，能顯著降低心血管和腎臟臨牀轉歸終點風險，減少卒中和心肌梗死的發生，改善生存質量。
SAL0112片作為口服的GLP-1R的偏向激動劑，具有與和多肽類GLP-1RA相似的藥理作用。目前，國內已上市的GLP-1RA均為肽類注射劑(如利拉魯肽注射液、司美格魯肽注射液、度拉糖肽注射液等)，長期頻繁注射或存在患者依從性較差等問題。SAL0112片系口服給藥，若能研發成功並獲批上市，將能有效改善2型糖尿病的給藥途徑，提高患者用藥便利性，增強用藥依從性。此外，作為小分子藥物，SAL0112片預期或將比口服多肽類藥物更能提高生物利用度，受飲食、合併用藥等因素的干擾更小；具有較大開發潛力。
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