系中國首個進行國際多服务中心3期臨床探讨的生物制品類似葯
系中國首個根据动物類似葯指導原則開發並獲得NMPA什么时候上市申請审批的曲妥珠單抗
系中國首個在歐盟報產的國產單抗微生物類似葯，同時首個被歐盟授理的「中國籍」曲妥珠單抗
之日起，復宏漢霖聯合其商務合作协议夥伴Accord相互推動中國综合性開發的曲妥珠單抗HLX02向歐洲藥品工作局（EMA）遞交了挂牌上市申請，並於最近正是獲得审理，用於治療HER2陽性的早乳腺癌炎癌、HER2陽性的轉移性乳腺癌炎癌，或者未經治療的HER2陽性的轉移性食道癌或胃/食管毗邻處腺癌。
該產品為復宏漢霖独立開發並擁有基本独立知識產權的單抗微生物制品類似葯。在此之前，HLX02已順利獲得國家藥品監督安全监督局（NMPA）的新葯出现申請立案，為國內首個報產的曲妥珠單抗微生物制品類似葯。2016年，復宏漢霖與英國Accord工厂達成商務联合協議，赋予Accord在歐洲地區（属于英國、法國、德國和法国等在內的53個國家）、中東及北非地區（17個國家）和地方獨聯體國家的HLX02獨家商業化權利。
復宏漢霖聯合創始人、總裁兼总裁執行官劉世高博土表示法：
十分高興听到HLX02的市场销售申請獲得歐洲藥品管理工作局审理，這预兆着復宏漢霖的葯政註冊效率、臨床的研究效率和質量體系实现了國際上的進一步骤認可，我們充满期待HLX02能夠儘快獲批市场销售，受惠國內相应高度大量朋友。
HLX02方向國際並非巧合，這是厂家世界上化產品開發戰略的非常重要作品。結合歐盟生物制品類似葯廣大的市場需要，HLX02 会直接採用國際多心中的臨床方案设计，在中國、波蘭、烏克蘭及菲律賓等世界上多個地區此次開展3期臨床試驗，對比HLX02聯合多西他賽與歐盟市售曲妥珠單抗聯合多西他賽在治療複發性或未經治療的HER2陽性轉移性乳腺癌癌人的可以科学性、安会性及免疫抗体原性，為HLX02歐盟申報出现逐步形成了紮實的數據基礎。
我院獲得歐盟新葯纳斯达克上市申請审批，也是復宏漢霖積極開展國際商務配合，拓宽高度配合夥伴的比较重要的事件。針對HLX02產品，復宏漢霖亦與雅各臣葯業、Cipla等机构开发配合，获得雅各臣在我们香港、澳門的HLX02的商業化權利及東南亞几市場的商業化權利優先洽談權，获得Cipla在亞太和拉丁北美洲地區位置新興國家市場的開發和商業化。
除HLX02外，復宏漢霖產品管線中多厚候選藥物也在同部优质開發，藉助司全坐向、全注意事项的自动開發网上平台，全国将大陆与香港。澳门紧紧地联系起来研發主密切达成合作能默契配合，领着經驗豐富的資深專家共同的為實現司的願景而緊密达成合作，對標國際高达質量標準建设详细的質量安全管理體系，不斷升级產品進入國際新趋势法規市場的註冊申報水平，推動多個處於臨床後期開發的產品在近几年陸續實現商業化。
讓我們一起感触復宏漢霖更好地產品在未來有優秀的臨床表現和成功失败的商務合作关系，為全球最大眾多醫療实际需求还没有得到了滿足的患者帶去恩点。
European Medicines Agency Accepted First 「China-Developed」 Biosimilar - Henlius HLX02 Marketing Authorization Application for Review
Henlius trastuzumab biosimilar HLX02 has been accepted by the European Medicines Agency (EMA) for reviewing its Marketing Authorization Application (MAA) . HLX02 has established three 「Firsts」 both in China and globally.
First China biosimilar conducted a multi-center, international phase 3 clinical trial
First trastuzumab developed in China following the National Medical Products Administration (NMPA) technical guideline for biosimilar with the New Drug Application (NDA) received the acceptance for review from the NMPA
First China-developed trastuzumab biosimilar accepted for MAA review by the EMA
June 21, 2019, Shanghai, China – Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02. The European rights of this product have been out-licensed to its business partner Accord Healthcare. HLX02 is indicated for human epidermal growth factor receptor 2-positive (HER2+) early-stagebreast cancer, HER2+ metastatic breast cancer, and untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.
The New Drug Application (NDA) of HLX02, a biosimilar of a classical targeted therapy for cancers, has been accepted for review by the National Medical Products Administration (NMPA) in China. The acceptance for review by the EMA demonstrates that the 「China-developed」 biosimilar has entered the global stage with the hope to benefit patients globally.
「We are very pleased to receive the EMA acceptance to review of our trastuzumab biosimilar HLX02 MAA submission,」 said Dr. Scott Liu, co-Founder, President and CEO at Henlius. 「It shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally recognized. We plan to work closely with EMA on this HLX02 MAA and hope to benefit HER2+ cancer patients globally with its high-quality and affordability.」
The Phase 3 study aimed for head-to-head similarity evaluation in efficacy, safety and immunogenicity profiles between HLX02 and reference trastuzumab sourced from the European Union (EU) in 649 previously untreated patients with HER2+ metastatic breast cancer in mainland China, Ukraine, Poland and the Philippines. The Phase 1 study has successfully demonstrated the equivalence in pharmacokinetics and safety profiles between HLX02 and reference trastuzumab sourced from both EU and China.
Apart from the R&D and innovation efforts, Henlius is also actively creating new business models and expanding its global presence. The acceptance of the regulatory submission of trastuzumab biosimilar HLX02 MAA in Europe is another example of strong progress Henlius continues to make across the robust biosimilars portfolio. The acceptance of HLX02 MAA review marks a key milestone for the collaboration between Henlius and its partner Accord. In June 2018, Henlius signed the licensing and supply agreements with Accord. Under this partnership, Accord is exclusively authorized to commercialize HLX02 in 53 countries including UK, France, Germany, and Italy in Europe; 17 countries in Middle East-North Africa (「MENA」) and certain countries in Commonwealth of Independent States (「CIS」).
Henlius has strong capabilities in integrated innovation. Its first rituximab injection (HLX01) has been successfully launched in China. Currently, both HLX02 (trastuzumab biosimilar) and HLX03 (adalimumab biosimilar) NDAs are under NMPA review. Henlius has a diverse and robust R&D pipeline with IND/CTA filings for 13 products and 2 combination therapies in 23 indications.
About Henlius
Henlius is a leading biopharmaceutical company in China that offers high-quality, affordable and innovative drugs to patients worldwide. Founded in 2010 and headquartered in Shanghai with 2 R&D centers in Taipei and California, Henlius has established and continues to expand its comprehensive product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.