Reliable Quality

Affordable Innovation

Research Progress

Up to date, in addition to one product launched commercially and two products under New Drug Application (NDA) review, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. 漢利康®( HLX01, rituximab injection), the first product of Henlius, has been granted approval by the National Medical Products Administration (NMPA) in February 2019 as the first China's biosimilar. The NDAs of HLX03 (adalimumab injection)and HLX02 (trastuzumab for injection) were accepted by the NMPA and assigned to priority review list. HLX02 is the first China-manufactured biosimilar to conduct a global, multi-centre Phase 3 clinical trial in Mainland China, Poland, Ukraine and the Philippines. Its Marketing Authorisation Application (MAA) was also accepted by European Medicines Agency(EMA)for review in June 2019. In May 2020, the Committee for Medical Products for Human Use (CHMP) of EMA adopted a positive opinion on MAA for HLX02.

Products in R&D
Target
Generic Name
Study Phase
Potential Indication
Study Phase
Product Pipeline

With our efficient and innovative in-house capabilities, we have developed a diversified and advanced drug pipeline with a focus in the fields of oncology, autoimmune diseases etc. 


                             

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