華北製藥(600812.SH)：重組人源抗狂犬病毒單抗注射液被納入擬優先審評品種公示名單
格隆匯 8 月 5日丨華北製藥(600812.SH)公佈，公司子公司華北製藥集團新藥研究開發有限責任公司(“新藥公司”)的重組人源抗狂犬病毒單抗注射液2020年8月5日被國家藥品監督管理局藥品審評中心(“國家藥品審評中心”)納入擬優先審評品種公示名單，公示期7日。
重組人源抗狂犬病毒單抗注射液(rhRIG)是新藥公司自主創新項目，被列為國家“重大新藥創制”科技重大專項品種。其作用機制及適應症為將本品與人用狂犬病疫苗聯用，用以補充人用狂犬病疫苗主動免疫過程中的抗體空白，可直接中和體內狂犬病毒，起到被動免疫作用，用於被狂犬或其它狂犬病毒易感動物咬傷、抓傷患者的被動免疫。2020年4月7日，該項目取得III期臨牀試驗報告，試驗結論為：重組人源抗狂犬病毒單抗注射液（rhRIG）聯合人用狂犬病疫苗對III級疑似狂犬病毒暴露人羣的暴露後預防達到主要療效和次要療效終點，且安全性良好，達到方案設定目標，試驗藥物重組人源抗狂犬病毒單抗注射液(rhRIG)是安全、有效的。(詳見臨2020-015號公告)2020年6月26日，國家藥品審評中心受理了重組人源抗狂犬病毒單抗注射液藥品註冊申請。
目前，國內尚無重組抗狂犬病毒單抗藥物上市銷售。國內可用於狂犬病毒暴露後預防的被動免疫製劑為抗狂犬病血清和狂犬病人免疫球蛋白。通過國家藥品監督管理局網站數據查詢結果顯示，截至目前國內有17家企業具有狂犬病人免疫球蛋白批准文號，未批准進口產品銷售。根據Insight數據庫統計的中檢院及七家藥品檢驗所公開的生物製品批簽發數據，2019年批簽發狂犬病人免疫球蛋白1216.6萬瓶(摺合200IU)。根據藥智網藥品中標信息查詢，狂犬病人免疫球蛋白2019年各地中標價為143.3元-218元(2ml/200IU)不等。
印度血清研究所研發的重組抗狂犬病毒單抗注射液SII RMab(Rabishield)已於2016年12月在印度批准上市；印度Zydus Cadila開發的鼠源單抗混合製劑Rabi Mabs(Twinrab)於2019年9月在印度獲得批准。公司未能從公開渠道查詢到上述公司關於該產品的市場銷售數據。
截至目前，該項目累計研發投入金額為16440.43萬元人民幣。
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