羅欣藥業(002793.SZ)：注射用帕瑞昔布鈉通過一致性評價
格隆匯1月13日丨羅欣藥業(002793.SZ)公佈，公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)於近日收到國家藥品監督管理局核准簽發的注射用帕瑞昔布鈉《藥品補充申請批准通知書》。
藥品名稱：注射用帕瑞昔布鈉；劑型：注射劑；註冊分類：化學藥品；規格：20mg、40mg；原藥品批准文號：國藥準字H20193380、國藥準字H20193381；通知書編號：2020B05514、2020B05513；上市許可持有人：山東羅欣藥業集團股份有限公司；審批結論：根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致性評價工作的公吿》(2020年第62號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。
帕瑞昔布鈉屬於非甾體抗炎藥，用於手術後疼痛的短期治療，是全球唯一可同時靜脈、肌肉注射用的COX-2(環氧化酶-2)抑制劑，具有鎮痛效果好，起效迅速，作用持久，能有效抑制痛覺超敏，且胃腸安全性高，不影響血小板功能，不會額外增加心血管風險等特點。
注射用帕瑞昔布鈉(商品名：Dynastat®)是由輝瑞和法瑪西亞公司聯合開發，劑型為凍乾粉針劑，於2002年在歐洲首次上市，目前已在德國、法國、英國等至少15個國家上市。2008年，注射用帕瑞昔布鈉(商品名：特耐)獲准在中國上市，規格為20mg、40mg。山東羅欣於2019年首次獲得注射用帕瑞昔布鈉生產批件，批准文號為國藥準字H20193380、國藥準字H20193381。
根據IQVIA數據，注射用帕瑞昔布鈉2019年度在全球的銷售金額為2.19億美元(以出廠價計算)，在我國境內銷售金額為15.20億元人民幣(以招標價計算)。
注射用帕瑞昔布鈉一致性評價申請被國家藥品監督管理局批准，根據國家相關政策，通過一致性評價的藥品品種，質量和療效等同原研產品，在醫保支付及醫療機構採購方面將予以適當支持。
注射用帕瑞昔布鈉是公司的首個COX-2抑制劑藥品，其通過一致性評價將進一步提高市場競爭力，擴大市場份額，同時為公司後續一致性評價產品研究及仿製藥開發積累了寶貴經驗。
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