復宏漢霖(02696.HK)HLX02(注射用曲妥珠單抗)通過GMP符合性現場檢查
格隆匯 7 月 7日丨復宏漢霖－Ｂ(02696.HK)發佈公告，公司全資子公司上海復宏漢霖生物製藥有限公司於今日收到上海市藥品監督管理局頒發的《藥品生產現場檢查結果告知書》，公司位於上海市徐彙區的生物藥生產基地順利通過上海市藥品監督管理局針對HLX02(注射用曲妥珠單抗)的原液(DS)生產南線及製劑(DP) 生產一線的現場檢查。
根據披露，HLX02(注射用曲妥珠單抗)是公司按照中國及歐盟生物類似藥指導原則自主開發的單抗生物類似藥，用於HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌及未經治療的HER2陽性的轉移性胃癌或胃╱食管交界處腺癌適應症治療。2019年4月，HLX02(注射用曲妥珠單抗)的新藥上市申請(NDA)獲國家藥品監督管理局受理，隨後被納入優先審評程序。
2020年4月，上海復宏漢霖生物製藥有限公司收到波蘭衞生監督機構Chief Pharmaceutical Inspector頒發的兩項《Certificate of GMP Compliance of a Manufacturer》，公司徐匯基地通過歐盟針對HLX02(注射用曲妥珠單抗，歐盟商品名：Zercepac®)原液(DS)及製劑(DP)線的GMP認證。2020年5月，Accord Healthcare S.L.U.(系公司合作伙伴Accord Healthcare Limited的全資子公司)遞交的HLX02(注射用曲妥珠單抗，歐盟商品名：Zercepac®)的營銷授權申請(Marketing Authorization Application, MAA)獲歐洲藥品管理局(European Medicines Agency, EMA)人用醫藥產品委員會(Committee for Medicinal Products for Human Use, CHMP)積極審評意見，建議批准MAA。
截至該公告日，在中國大陸上市的曲妥珠單抗為羅氏的赫賽汀®。根據IQVIA CHAP資料(IQVIA是全球領先的醫藥健康產業專業資訊和戰略諮詢服務提供者)，2019年曲妥珠單抗於中國大陸的銷售金額約為45.72億人民幣。
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