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海普瑞(09989.HK):依諾肝素鈉注射液全部規格率先通過一致性評價
格隆匯 10-26 19:59

格隆匯10月26日丨海普瑞(09989.HK)宣佈,公司全資附屬深圳天道近日收到國家藥監局核准簽發的《藥品補充申請批准通知書》,深圳天道國內在售全部五個規格的依諾肝素鈉注射液通過仿製藥品質和療效一致性評價。

該藥品適應症為:預防靜脈血栓栓塞性疾病(預防靜脈內血栓形成),特別是與骨科或普外手術有關的血栓形成。治療已形成的深靜脈血栓,伴或不伴有肺栓塞,臨牀症狀不嚴重,不包括需要外科手術或溶栓劑治療的肺栓塞。治療不穩定性心絞痛及非Q波心肌梗死,與阿司匹林合用。用於血液透析體外循環中,防止血栓形成。

深圳天道是國內首家申請並獲通過全部五個依諾肝素鈉規格的注射液仿製藥一致性評價的企業,所覆蓋的產品規格亦是已申報該品種一致性評價的企業中最全面的。目前,深圳天道的依諾肝素鈉製劑以出口歐盟為主,國內銷售佔整體依諾肝素鈉製劑業務收入相對較小。

公司表示,該次深圳天道的國內在售全部五個規格的依諾肝素鈉注射液率先通過一致性評價,將增加深圳天道在國內市場的競爭力,有利於深圳天道在各省的藥品集中採購不斷推廣的新市場環境下搶佔先機,預計將對公司未來經營業績產生正面影響。

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