復宏漢霖-B(02696.HK)：就HLX02注射用曲妥珠單抗於美國及加拿大的權利與INTAS訂立的許可協議
格隆匯 1 月 4日丨復宏漢霖-B(02696.HK)宣佈，公司已於2021年1月4日與Intas訂立一份許可協議，據此，公司同意向Intas授予一項獨家許可，供其於美國及加拿大(統稱"區域")商業化HLX02注射用曲妥珠單抗。
根據協議，許可產品在區域內的許可總里程碑付款包括：(a) 首付款2700萬美元，於協議日期支付；(b) 監管里程碑付款合計不超過1300萬美元，根據許可產品於美國食品藥品管理局(FDA)要求下的藥物代謝動力學研究進度及於美國的上市申請進度支付；及(c) 於區域內許可產品商業化後，商業銷售里程碑付款2500萬美元，於許可產品在區域內每取得5億美元的累計淨銷售額時支付。被許可方亦將根據區域內許可產品年度淨利潤的水準向許可方支付許可產品淨利潤的18%至50%的分層特許權使用費。
據悉，HLX02 注射用曲妥珠單抗(中國境內商品名：漢曲優®；歐盟商品名：Zercepac®)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HER2陽性的轉移性胃腺癌或胃食管交界處腺癌治療。HLX02注射用曲妥珠單抗(中國境內商品名：漢曲優®)的上市註冊申請(NDA)於2020年8月獲得國家藥品監督管理局批准。公司商務合作伙伴Accord HealthcareLimited的全資附屬公司遞交的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)於2020年7月獲歐盟委員會(European Commission, EC)批准。
截至公吿日期，公司已與多個合作伙伴(包括Accord HealthcareLimited、雅各臣藥業(香港)有限公司、Cipla Limited及Mabxience Research,S.L.)就HLX02訂立許可及商業化協議，以便成功於中國大陸境外(包括中國香港、中國澳門、馬來西亞、澳洲、紐西蘭、哥倫比亞、阿根廷、烏拉圭、巴拉圭，以及歐洲、中東－北非及獨聯體等80多個司法權區及地區)進行HLX02的商業化。
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