系中國首個進行國際多中心3期臨床研究的生物類似葯
系中國首個按照生物類似葯指導原則開發並獲得NMPA上市申請受理的曲妥珠單抗
系中國首個在歐盟報產的國產單抗生物類似葯，同時首個被歐盟受理的「中國籍」曲妥珠單抗
日前，復宏漢霖聯合其商務合作夥伴Accord共同推動中國自主開發的曲妥珠單抗HLX02向歐洲藥品管理局（EMA）遞交了上市申請，並於近日正式獲得受理，用於治療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。
該產品為復宏漢霖自主開發並擁有完全自主知識產權的單抗生物類似葯。此前，HLX02已順利獲得國家藥品監督管理局（NMPA）的新葯上市申請受理，為國內首個報產的曲妥珠單抗生物類似葯。2018年，復宏漢霖與英國Accord公司達成商務合作協議，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）和部分獨聯體國家的HLX02獨家商業化權利。
復宏漢霖聯合創始人、總裁兼首席執行官劉世高博士表示：
非常高興看到HLX02的上市申請獲得歐洲藥品管理局受理，這意味着復宏漢霖的葯政註冊能力、臨床研究能力和質量體系得到了國際上的進一步認可，我們期待HLX02能夠儘快獲批上市，惠及國內以及全球更多患者。
HLX02走向國際並非偶然，這是公司全球化產品開發戰略的重要成果。結合歐盟生物類似葯廣大的市場需求，HLX02 直接採用國際多中心的臨床方案，在中國、波蘭、烏克蘭及菲律賓等全球多個地區同步開展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陽性轉移性乳腺癌患者的有效性、安全性及免疫原性，為HLX02歐盟申報上市奠定了紮實的數據基礎。
此次獲得歐盟新葯上市申請受理，也是復宏漢霖積極開展國際商務合作，拓展全球合作夥伴的重要事件。針對HLX02產品，復宏漢霖亦與雅各臣葯業、Cipla等公司建立合作，授予雅各臣在香港、澳門的HLX02的商業化權利及東南亞若干市場的商業化權利優先洽談權，授予Cipla在亞太和拉丁美洲地區部分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款候選藥物也在同步高效開發，藉助公司全方位、全流程的自主開發平台，全球三地研發中心密切配合，一群經驗豐富的資深專家共同為實現公司的願景而緊密合作，對標國際最高質量標準建立全面的質量管理體系，不斷提升產品進入國際主流法規市場的註冊申報能力，推動多個處於臨床後期開發的產品在近年陸續實現商業化。
讓我們共同期待復宏漢霖更多產品在未來有優秀的臨床表現和成功的商務合作，為全球眾多醫療需求尚未得到滿足的病患帶去福音。
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.