科倫藥業(002422.SZ)：唑來膦酸注射液獲藥品註冊批件
格隆匯1月17日丨科倫藥業(002422.SZ)公佈，公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“唑來膦酸注射液”的《藥品註冊批件》。
藥品名稱：唑來膦酸注射液；劑型：注射劑；規格：100ml：4mg(按C5H10N2O7P2計)；申請事項：國產藥品註冊；註冊分類：化學藥品3類；申報階段：生產；受理號：CYHS1800287；藥品批准文號：國藥準字H202003010；審評結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，本品符合藥品註冊的有關要求，批准註冊，發給藥品批准文號。
唑來膦酸注射液(100ml：4mg)為諾華公司開發的雙膦酸鹽類藥物，2001年在歐盟首獲批，後相繼在美國、日本等批准上市，用於治療惡性腫瘤引起的高鈣血癥，以及聯合標準抗腫瘤藥物用於治療實體腫瘤骨轉移患者和多發性骨髓瘤患者的骨骼損害。
骨轉移為惡性腫瘤常見併發症，引起骨痛、病理性骨折、高鈣血癥等一系列骨相關事件，嚴重影響患者生活質量，顯著縮短患者生存時間。臨牀治療以骨改良藥物為基礎，同時聯用常規抗腫瘤治療和對症支持治療。雙膦酸鹽為常用的骨改良藥物。
唑來膦酸為第三代雙膦酸鹽，與第一、二代相比，具有抗骨吸收作用更強、降低骨相關事件發生率療效更優的臨牀優勢，為目前全球唯一批准用於實體瘤不同類型骨轉移和多發性骨髓瘤骨骼損害的雙膦酸鹽類藥物。目前唑來膦酸已被美國NCCN《多發性骨髓瘤臨牀實踐指南(2020.V2)》、中國CSCO《乳腺癌診療指南2018V1》等國內外權威指南和專家共識推薦使用。我公司唑來膦酸注射液(100ml：4mg)為國內首家獲批的輸液劑型，與現有的粉針與水針劑型相比，具有可直接靜脈輸注、有效防止錯配與配製污染、提高用藥安全和醫護效率的優勢。2018年唑來膦酸粉針和水針中國銷售12.4億元。
公司唑來膦酸注射液(100ml：4mg)為2015年國家藥監政策改革後，按照仿製藥必須與原研一致的要求研究、申報與獲批，質量和療效與原研(商品名：ゾメタ/ZOMETA，ノバルティスファーマ株式會社生產)等同。
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