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Henlius Has Completed the Phase 3 Study of Its Adalimumab Injection HLX03

2019-07-04

Henlius announced the completion of a Phase 3 clinical trial of adalimumab injection HLX03 in patients with moderate-to-severe plaque psoriasis (PS).


This confirmatory study was a randomized, double-blind, multicenter, active-controlled parallel phase 3 clinical study to investigate the efficacy, safety, immunogenicity and pharmacokinetics of recombinant fully humanized anti-TNFα monoclonal antibody injection (HLX03) compared with reference adalimumab injection in patients with moderate-to-severe plaque psoriasis. The study is one of the clinical studies to demonstrate the biosimilarity of HLX03 and reference drug.


HLX03 is the second monoclonal antibody (mAb) biosimilar developed by Henlius to submit New Drug Application (NDA). Henlius submitted NDA for HXL03 to NMPA for the indications of PS, Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), which soon assigned HLX03 into its priority evaluation list. The results from the Phase 3 study of HLX03 showed the similarity in efficacy of HLX03 compare to reference drug for the treatment of moderate-to-severe plaque psoriasis. The pharmacokinetics, safety and immunogenicity profiles of HLX03 were similar to the reference drug.


"HLX03 is Henlius’ first product focused on autoimmune diseases,” said Dr. Scott Liu, the co-Founder, President and CEO at Henlius, “We expect the new drug to be launched as soon as possible to benefit more patients. As a leading biopharmaceutical company in China with robust pipeline, we are committed to provide high-quality, affordable treatments for patients with cancer and autoimmune diseases globally."


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 two 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.


Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 13 products and 3 combination therapies worldwide. HLX01 (rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their New Drug Applications under primary review by the NMPA. HLX02 is the first biosimilar developed in China to enter a global multi-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, the Marketing Authorization Application for HLX02 was accepted to review by EMA.