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海普瑞宣佈旗下肝素鈉和依諾肝素鈉原料藥於印度獲批並實現商業銷售

(2022年3月15日,中國深圳) 深圳市海普瑞藥業集團股份有限公司(以下簡稱“海普瑞“)今日宣佈,旗下肝素鈉和依諾肝素鈉原料藥近日於印度獲批並實現商業銷售。

肝素鈉和依諾肝素鈉都是用於預防和治療深靜脈血栓或肺栓塞的抗凝血劑,源自健康生豬的小腸黏膜,是目前世界上最有效和臨牀用量最大的抗凝血藥物,也是治療抗凝血的金標準藥物。相較肝素鈉,依諾肝素鈉的安全性更好,在臨牀上擁有廣泛應用。

全球範圍內,兩種藥物都需要大量的原料藥供應以製成注射液劑型為醫患使用。作為全球領先的肝素鈉和依諾肝素鈉原料藥供應商,在過往的20多年間,海普瑞穩定向全球35個國家和地區提供高質量的原料藥。2008年,在美國爆發的“百特事件”中,海普瑞以“零缺陷”通過美國食品藥品監督管理局(FDA)現場複查,一躍成為美國標準肝素製劑唯一的原料藥供應商,提供當時95%以上的肝素製劑原料藥,並參與次年美國藥典標準修訂。其後,海普瑞的肝素鈉和依諾肝素鈉原料藥生產線多次通過中國、美國、歐盟、澳大利亞、巴西、哥倫比亞等國現場檢查,並7次“零缺陷”通過美國FDA審查。

印度擁有13.9億人口1,且由於宗教原因不具備生豬資源,因此是中國出口肝素鈉和依諾肝素鈉原料藥最主要的市場之一。此次在印度獲批,海普瑞也擁有了印度該超大體量市場的准入門檻,並在獲批後當月即拿到在手訂單,得以為該地醫患提供高質量且具有價格競爭力的原料藥系列產品,樹立中國“質”造的國際良好聲譽。

海普瑞董事長兼總裁李鋰表示:“深耕肝素領域20餘年,海普瑞是少有打通肝素產業鏈上游到終端的企業。儘管集團的策略重心正在逐漸移至製劑端,我們的製劑業務在集團營收中的比重也超過了原料藥業務,但我們也不能忘記全球市場對於高質量原料藥的需求,繼續穩定地持續地為有需要的市場提供產品,以多樣的形式為全球的抗凝血事業貢獻來自中國的力量。“

丨關於海普瑞丨

海普瑞於1998年成立於深圳,是擁有A+H雙融資平台的領先跨國製藥企業,主要業務覆蓋肝素全產業鏈、生物大分子CDMO和創新藥物的投資、開發及商業化。集團的三大板塊業務相互協同,以臨牀未滿足需求為驅動,致力於為全球患者提供高質量的安全有效藥物和服務,護佑健康。欲知詳情,請點擊:http://www.hepalink.com/

1. 根據中國外交部官網數據(最近更新時間:2021年8月)

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