復宏漢霖-B(02696.HK)：HLX02獲歐洲藥品管理局(EMA)人用醫藥產品委員會(CHMP)積極審評意見
格隆匯5月31日丨復宏漢霖-B(02696.HK)公佈，近日，Accord Healthcare S.L.U.(公司商務合作伙伴Accord Healthcare Limited(“Accord”)的全資子公司)遞交的HLX02(注射用曲妥珠單抗)(“HLX02”)用於HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌，以及未經治療的HER2陽性的轉移性胃癌或胃╱食管交界處腺癌治療的營銷授權申請(Marketing Authorization Application, MAA)(“MAA”)獲歐洲藥品管理局(European Medicines Agency, EMA)(“EMA”)人用醫藥產品委員會(Committee for Medicinal Products for Human Use, CHMP)(“CHMP”)積極審評意見，建議批准MAA。CHMP的審評意見將會被遞交至歐盟委員會(European Commission, EC)(“EC”)，EC將參考CHMP的意見並在未來2-3個月做出最終審查決定。一旦獲得批准，HLX02將在所有歐盟成員國及冰島、列支敦士登和挪威(各自為歐洲經濟區(EEA)國家)獲得集中上市許可。
此次EMA的積極意見主要是基於對HLX02一系列研究數據的審查，包括質量對比研究、臨牀前研究及臨牀研究。這些數據都證明了HLX02與參照藥(Herceptin®)在質量、安全性和有效性方面的高度相似。2020年4月，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》，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原液(DS)及製劑(DP)線的GMP核查。
HLX02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的治療。2019年4月，HLX02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，EMA受理了Accord Healthcare S.L.U.就HLX02遞交的MAA。
截至公告日，於歐盟及冰島、列支敦士登和挪威(各自為EEA國家)上市的曲妥珠單抗主要為Roche的Herceptin®，Celltrion的Herzuma®，Samsung Bioepis的Ontruzant®等，根據IQVIA MIDAS TM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年曲妥珠單抗於歐盟及冰島、列支敦士登和挪威(各自為EEA國家)的銷售額約13.68億美元。
2018年6月20日，公司與Accord簽訂《許可協議》。公司授予Accord在歐洲地區(包括英國、法國、德國和意大利等在內的53個國家)、中東及北非地區(17個國家)和部分獨聯體國家就HLX02產品的獨家商業化權力。根據協議約定，Accord將向公司支付至多4050萬美元的首付款及里程碑費用。此外，在協議約定期限內，Accord應根據HLX02在許可區域內的年淨銷售額達成情況，按淨銷售額產生利潤13.5%至25%的比例區間支付公司許可使用費。
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