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華森製藥(002907.SZ):合作方奧美拉唑碳酸氫鈉膠囊獲批上市
格隆匯 05-25 16:15

格隆匯5月25日丨華森製藥(002907.SZ)公佈,公司與2018年6月28日與北京百奧藥業有限責任公司(簡稱“百奧藥業”)就“奧美拉唑碳酸氫鈉膠囊(20mg;1100mg)”項目技術開發的MAH權益及生產批件持有人變更協商一致並簽訂了《技術開發及轉讓合同》。

根據《技術開發及轉讓合同》內容,公司為奧美拉唑碳酸氫鈉膠囊(20mg;1100mg)MAH權益的實際享有者,目前公司合作方百奧藥業已於近日收到國家藥監局核准簽發關於奧美拉唑碳酸氫鈉膠囊(20mg;1100mg)的《藥品註冊證書》(證書編號:2021S00512)(第3類),後續公司將與合作方一起進行MAH持有人的變更工作。

公司合作方百奧藥業取得奧美拉唑碳酸氫鈉膠囊(20mg;1100mg)《藥品註冊批件》後,還需與公司進行MAH權益及生產批件的持有人變更,在持有人變更為公司後,公司將迅速對該品種進行市場導入。

奧美拉唑碳酸氫鈉膠囊為消化系統用藥,適用於治療十二指腸潰瘍、胃食管反流病及其愈後維持,市場空間廣闊,符合公司“立足於三大優勢領域(消化系統領域、耳鼻喉用藥領域以及精神神經系疾病用藥領域),並逐步拓展產品管線”的公司戰略。

該產品的獲批及MAH權益轉移成功後上市銷售,將進一步夯實公司在消化系統用藥領域的市場競爭力,有利於增強公司持續盈利能力,符合公司發展戰略及全體股東的利益。

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