Henlius trastuzumab biosimilar HLX02 has been accepted by the European Medicines Agency (EMA) for reviewing its Marketing Authorizati🦹on Application (MAA) . HLX02 has established three “Firsts”⛎ both in China and globally.
Firstꦅ China biosimilar conducted a multi-center, international𒊎 phase 3 clinical trial
First trastuzumab developed in China following the National Medicaꩵl 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 f💫ꦑor 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 g🧸astric 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” biosi🅰milar has entered the global stage wit♐h the hope to benefit patients globally.
“We are very pleased to receive the EMA acceptance to review of our trastuzumab biosimilar HLX꧙02 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 wiౠth its high-quality and affordability.”
The Phase 3 study aimed for head-to-head similarity evaluation in efficacy, safety and immunogenicitꦐy 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. Th🎃e 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, Accor🐻d 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 comprehensivꦅe product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.