海普瑞(09989.HK)：依諾肝素鈉注射液取得美國食品藥物管理局批准
格隆匯 9 月 21日丨海普瑞(09989.HK)公告，旗下全資附屬公司深圳市天道醫藥有限公司("深圳天道")收到通知，美國食品和藥物管理局("FDA")已批准其註冊成為一家依諾肝素鈉注射液上市許可持有人(該持有人在仿製藥領域擁有廣泛的渠道和豐富的經驗，2019年實現淨銷售收入逾百億美元)的藥物及原料藥供應商。
藥品名稱：依諾肝素鈉注射液(Enoxaparin Sodium Injection)。適應症：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。
目前，集團旗下的Inhixa、Neoparin和Prolongin三個品牌的依諾肝素鈉注射液產品，已合共在35個國家獲批並在21個國家實現銷售，同時亦可向包括美國在內的其他15個國家的客户供應依諾肝素鈉注射液。是次獲批也是深圳天道的依諾肝素鈉原料藥藥物主文件DMF(Drug Master File)在美國首次為FDA批准激活作用。
美國是全球依諾肝素鈉注射液銷售快速增長的主要市場，根據弗若斯特沙利文報告，2019年美國依諾肝素鈉製劑市場銷售約為4.55億美元，約佔全球市場銷售的17%；預計美國市場將以10.7%的年複合增長率於2025年達到8.38億美元。
2020年上半年，集團依諾肝素鈉注射液的全球銷售增長37%，未經審計銷售收入為人民幣631.3百萬元。集團是美國依諾肝素鈉製劑上市許可持有人戰略伙伴目前僅有的依諾肝素鈉製劑供應商，供應藥品，而由該合作伙伴負責所有銷售與分銷相關費用。
獲批註冊是集團製劑業務開拓美國市場的起點，預期將於今年底前實現銷售，未來在美國的製劑業務增長將進一步鞏固集團的全球佈局。
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