復宏漢霖-B(2696.HK)：獲歐盟GMP證書，打破國產單抗生物藥“出海”壁壘
格隆匯4月23日丨2020年4月23日，復宏漢霖-B（2696.HK）宣佈，公司已經順利通過HLX02曲妥珠單抗原液（DS）和製劑（DP）線的歐盟GMP現場核查，正式獲得波蘭衞生監督機構Chief PharmaceuticalInspector
簽發的兩項歐盟GMP證書（Certificateof GMP Compliance of a Manufacturer
）。
歐盟GMP認證是國際公認的最權威和嚴謹的認證之一，不僅在近30個成員國之間彼此互認共享，同時也可與美國、加拿大等簽訂互認協議（MRA）的國家共享核查結果，在全球範圍內具有重大影響力，被視為藥品登陸國際市場的“通行證”。根據公開數據顯示，目前國內本土僅有兩家公司獲得歐盟GMP認證可用於生產大分子單抗藥，復宏漢霖正是其中一家。
據悉，HLX02曲妥珠單抗是中國首個開展國際多中心（中國大陸、烏克蘭、波蘭和菲律賓）3期臨牀試驗的生物類似藥，也是中國首個按照生物類似藥指導原則開發並獲得NMPA上市申請受理的曲妥珠單抗，有望用於治療HER2陽性早期乳腺癌、HER2陽性轉移性乳腺癌及HER2陽性轉移性胃癌。
在生產上，復宏漢霖徐匯基地正式成為國內首個獲得歐盟GMP認證用於生產自主研發抗體生物藥的GMP工廠，HLX02曲妥珠單抗也成為國內首個獲得歐盟GMP認證的國產生物類似藥，這意味着復宏漢霖已經具備了符合歐盟標準的商業化生產基地和質量管理體系，打破了國產單抗生物藥在海外上市的GMP壁壘。
在海外佈局上，復宏漢霖已針對HLX02前瞻性地開展了國際商業化佈局，積極開拓海外市場。公司陸續與Accord、Cipla、Mabxience和雅各臣藥業等國際一流的生物製藥企業達成合作，促進HLX02在全球80多個國家和地區的商業化進程。2019年6月，公司聯合Accord共同推動HLX02向歐洲藥品管理局（EMA）遞交營銷授權申請（MAA），使得HLX02成為首個在歐盟報產並獲受理的“中國籍”曲妥珠單抗，有望實現歐盟市場中國生物類似藥零的突破。
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