江蘇吳中(600200.SH)：注射用蘭索拉唑通過仿製藥一致性評價
格隆匯11月16日丨江蘇吳中(600200.SH)公佈，公司全資子公司蘇州製藥廠收到了國家藥監局核准簽發的關於“注射用蘭索拉唑”的《藥品補充申請批准通知書》，該藥品通過仿製藥質量和療效一致性評價(簡稱“仿製藥一致性評價”)。
蘭索拉唑屬於第二代質子泵抑制劑。質子泵抑制劑是目前治療消化性潰瘍最先進的一類藥物。質子泵抑制劑的作用機制：胃H+-K+酶位於胃壁細胞的胃粘膜腔側，其功能是泵出H+(質子)，使之進入胃粘膜腔，提高胃內的酸度，作為交換，將K+泵入胃壁細胞。壁細胞還存在另外的離子轉運系統，將K+和Cl-同時排到胃粘膜腔內，總的結果是保持胃內HCl水平，激活M3受體、CCK2受體、H2受體都能激活H+-K+-ATP酶，增加胃酸分泌，因此，抑制H+-K+-ATP酶是最直接和有效的抑酸手段。
質子泵抑制劑均屬於弱酸性的苯並咪唑類化合物，pKa大約為4，在酸性的胃壁細胞分泌小管內，轉化為次磺酸和亞磺酰胺，後者與H+-K+-ATP酶α亞單位的巰基共價結合使酶失活，減少胃酸分泌。由於藥物與酶的結合不可逆，因此其抑制胃酸分泌的作用強大並且持久，同時使胃蛋白酶的分泌減少。該類藥物作用於胃酸分泌的最後一個環節，因此無論是否存在其他刺激胃酸分泌的因素，本類藥物均可以有效抑制胃酸的分泌。該類藥物已經超過H2受體阻斷藥，成為目前世界上應用最廣的抑制胃酸分泌的藥物。
公司注射用蘭索拉唑一致性評價項目於2018年立項，於2020年3月提交注射用蘭索拉唑一致性評價的補充申請，並於近日獲得藥品補充申請批件。國內已有多家企業相關產品獲批上市，除公司外，江蘇奧賽康藥業股份有限公司、山東羅欣藥業集團股份有限公司等多家企業已通過(或視同通過)一致性評價。經查詢，注射用蘭索拉唑2020年國內樣本醫院銷售額約為5.37億元(PDB數據庫)。截至2021年10月末，公司注射用蘭索拉唑項目共計已投入研發費用約為507.55萬元人民幣。
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