羅欣藥業(002793.SZ)：替戈拉生片獲准開展新適應症臨牀試驗
格隆匯3月6日丨羅欣藥業(002793.SZ)公佈，近日，公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)收到國家藥品監督管理局下發的替戈拉生片幽門螺桿菌感染適應症的《藥物臨牀試驗批准通知書》。
替戈拉生片是鉀離子競爭性酸阻滯劑類藥物(Potassium-Competitive AcidBlockers，P-CAB)，其抑制酸分泌的作用機制為競爭性結合壁細胞內H+/K+-ATP酶(質子泵)的鉀離子結合部位。與質子泵抑制劑(PPI)不同，P-CAB可直接抑制H+/K+-ATP酶，而無需在強酸環境下活化。而且，無論 H+/K+-ATP酶活化與否，P-CAB均可與之結合。P-CAB與抗生素聯合用藥，通過其抑酸作用，為抗生素根除幽門螺桿菌提供最佳 pH 環境。
替戈拉生片具有開發胃食管反流、消化性潰瘍等酸相關疾病適應症的潛力，具有起效快、作用時間長、酸性條件下穩定、可同時抑制激活和靜息狀態質子泵等特點。
替戈拉生片於2019年在韓國正式上市，目前僅在韓國上市銷售。根據IQVIA數據，替戈拉生片2020年在韓國銷售金額為50,171,652美元，較2019年增長106.3%；2021年銷售金額為72,517,358美元，較2020年增長44.5%。在我國境內暫無產品上市。
幽門螺桿菌為世界級一類致癌物。流行病學研究表明世界範圍內一半以上人口感染幽門螺桿菌,我國至少7億人感染幽門螺桿菌，感染率超過50%，P-CAB與適當的抗菌療法聯用根除成人幽門螺桿菌感染市場前景廣闊。
公司在消化領域一直具備較強的市場競爭力，2015年10月，山東羅欣與HK inno.N Corporation達成協議，獲得替戈拉生片在中國境內獨家開發、生產及商業化權益，目前替戈拉生片反流性食管炎適應症1類新藥上市申請已獲得受理；十二指腸潰瘍適應症III期臨牀試驗正在進行中。此次獲准開展臨牀試驗的適應症為與適當的抗菌療法聯用根除成人幽門螺桿菌感染。此外，2021年6月23日山東羅欣與HK inno.N Corporation就引進替戈拉生注射劑產品達成協議，獲得該產品在中國的獨家開發、生產和商業化的權利，體現了公司在該領域持續深耕和布局的決心及優勢。
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