海正藥業(600267.SH)：子公司獲得注射用哌拉西林鈉他唑巴坦鈉補充申請批件
格隆匯11月29日丨海正藥業(600267.SH)公佈，近日，公司全資子公司瀚暉製藥有限公司(“瀚暉製藥”)收到國家藥品監督管理局核准簽發的關於注射用哌拉西林鈉他唑巴坦鈉的《藥品補充申請批准通知書》。
特治星為國內上市的原研藥品，適用於治療包括下列病症在內的由指定細菌的易感分離株引起的中度至重度感染：
1.由產生β-內酰胺酶的大腸桿菌分離株或脆弱擬桿菌族的以下成員導致的闌尾炎(併發穿孔或膿腫)和腹膜炎：脆弱擬桿菌、卵形類桿菌、多形擬桿菌或普通擬桿菌。
2.單純性及複雜性皮膚和皮膚組織感染，包括由產生β-內酰胺酶的金黃色葡萄球菌分離株導致的蜂窩組織炎、皮膚膿腫和缺血性/糖尿病足感染。
3.由產生β-內酰胺酶的大腸桿菌分離株導致的產後子宮內膜炎或盆腔炎。
4.由產生β-內酰胺酶的流感嗜血桿菌分離株導致的社區獲得性肺炎(僅限中等嚴重程度)。
5.由產生β-內酰胺酶的金黃色葡萄球菌和對哌拉西林/他唑巴坦敏感的鮑曼不動桿菌、流感嗜血桿菌、克雷伯氏肺炎菌和銅綠假單胞菌導致的醫院獲得性肺炎(中等至嚴重程度)(由銅綠假單胞菌導致的醫院獲得性肺炎應與氨基糖苷類藥物合用治療)。
由多種細菌混合感染，包括懷疑感染部位(腹腔內、皮膚和軟組織、上下呼吸道、婦科)存在需氧菌和厭氧菌的感染。
注射用哌拉西林鈉他唑巴坦鈉原研技術廠家為Pfizer Limited。經查詢IMS數據庫，注射用哌拉西林鈉他唑巴坦鈉2020年全球銷售額約為208,285.93萬美元，其中中國銷售額約為72,808.32萬美元；2021年1-6月全球銷售額約為111,988.12萬美元，其中中國銷售額約為41,631.82萬美元。
2020年瀚暉製藥特治星®銷售額約為7.36億元人民幣。特治星®為海正藥業與輝瑞製藥有限公司(“輝瑞公司”)成立合資公司(即目前的瀚暉製藥)時，輝瑞公司注入的品種，瀚暉製藥於2021年2月向國家藥監局提交了注射用哌拉西林鈉他唑巴坦鈉的藥品生產技術轉讓申請，於2021年11月獲得批件。
截至目前，瀚暉製藥在特治星®技術轉移項目上已投入約3.58億元人民幣。該藥品技術轉讓系將特治星®的原研技術從Pfizer Limited轉移至瀚暉製藥，意味着瀚暉製藥已擁有了該藥品的生產權和所有權。
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