兆科眼科(06622.HK)兩產品通過中國藥品註冊現場核查
兆科眼科-B(06622.HK)公布,於5月13日,公司的兩項藥品-貝美素(口塞)嗎洛爾滴眼液(在中國用於治療青光眼的潛在首仿藥,為前列腺素類似物與乙型受體阻斷劑的固定劑量複方),及鹽酸依匹斯汀滴眼液(在中國用於治療過敏性結膜炎的潛在首仿藥,具有抗組胺及穩定的肥大細胞雙重作用機制),通過國家藥品監督管理局藥品審評檢查大灣區分中心藥品註冊現場核查,核實上述兩項藥品的研製過程及生產過程中的原始記錄及資料。
公司已向國家藥監局提交了以上所闡述之兩種仿製藥(貝美素(口塞)嗎洛爾滴眼液及鹽酸依匹斯汀滴眼液)的簡化新藥申請。公司預期在2022年獲得監管批准後開始將該等兩個產品商業化,及預期有關商業化有助公司與合作夥伴及關鍵意見領袖、眼科醫生及醫院等戰略渠道建立緊密下游聯繫。
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