Henlius obtained six approvals for clinical trial,
and submitted one IND application.
HLX01 Phase III trial went on smoothly.
HLX02 Phase I trial was completed and was proven to be safe and clinically equivalent
to the originator.In addition, the global multi-centre Phase III trial has been initiated.
HLX03、HLX04 entered Phase I trial.
Henlius completed the first consultation to EMA (European Medicines Agency),and obtained
the positive feedback of HLX02 Phase III trial carried out in Europe and exempt the procedures of face-to-face meetings.
The innovative product of HLX07 obtained three approvals from mainland China、Taiwan
and the US FDA，with the fastest pace in Taiwan that phase I trial has been initiated.
The innovation product of HLX07 entered the national stage of PCTmain patent,
the other innovative product HLX06 officially submitted PCT invention patent application.
Strengthen innovative research and development,
obtained licenses of two innovative projects from the US and the South Korea.
Henlius obtained the certificate of high-tech enterprises.
The monoclonal antibodies industrialization bases came into service
and the single-use bioreactor was successfully amplified to 2000 L.
The《Foreign Pharmaceutical Single-use System Application and Technology Documention》
compiled by experts i.e. Pro. Junli Zhang from Henlius was officially published in Beijing.
Henlius's quality/manufacturing system and new facility passed the inspection of EU QP,
and will be able to supply sample for clinical trials of four projects carried out in EU.
《Biosimilars of monoclonal antibodies：a practical guide to manufacturing and preclinical and clinical development》
compiled by three scientists i.e. Weidong Jiang、Ziyang Zhong and Scott Liu from Henlius was officially published.