復宏漢霖(02696.HK)獲歐盟GMP證書
格隆匯4月23日丨復宏漢霖－Ｂ(02696.HK)發佈公告，近日，公司全資子公司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》，分別為原液線(DS)與製劑線(DP)的認證。公司位於上海市徐彙區的生物藥生產基地順利通過歐盟針對HLX02(注射用曲妥珠單抗)的原液 (DS)及製劑(DP)的GMP核查。
根據披露，HLX02(注射用曲妥珠單抗)是公司按照歐盟生物類似藥指南自主開發的單抗生物類似藥，擬用於HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌及HER2陽性的轉移性胃癌適應症的治療。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。2019年6月，歐洲藥品管理局(EMA)受理公司商務合作伙伴 Accord Healthcare Limited 就HLX02(注射用曲妥珠單抗)遞交的營銷授權申請(MAA)。
截至該公告日，於全球範圍內上市的曲妥珠單抗主要為羅氏的赫賽汀， Amgen/Allergan的Kanjinti，Celltrion的Herzuma等，根據IQVIA MIDASTM 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年曲妥珠單抗於全球範圍內的銷售額約為61.43億美元。
根據歐盟成員國之間的GMP互認制度，本次獲得波蘭衞生監督機構Chief Pharmaceutical Inspector的GMP證書，標誌着公司徐匯基地已符合歐盟 GMP標準。次獲得GMP證書後，HLX02(注射用曲妥珠單抗)尚需獲得歐盟營銷授權申請(MAA)批准後方可於歐盟上市。
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