You are here: Industry Insights > Henlius

News List

Which Will Market the First Chinese-produced Trastuzumab Biosimilar: Sunshine Guojian or Henlius? PharmaSources/Dopine
June 15, 2020
HER2-positive breast cancer has a high degree of malignancy and fast progression. Trastuzumab is the standard first-line regimen for adjuvant, neoadjuvant and metastatic cancer treatment of HER2-positive breast cancer.
Henlius' anti-PD-1 mAb MRCT achieved 15.38 months OS in first-line treatment of SCLC, reducing the risk of death by 38% of the overall population prnasia
December 21, 2021
Shanghai Henlius Biotech, Inc. (2696.HK) successfully held its Global R&D Day themed "H-evolution: From Biotech to Biopharma", and released its interim analysis results of Phase 3 clinical study (ASTRUM-005)...
Henlius' Phase 3 clinical study of novel PD-1 inhibitor serplulimab for the treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) meets primary study endpoint prnasia
December 08, 2021
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first interim analysis met the primary study endpoint of the overall survival (OS) of the Phase 3 clinical study (NCT04063163) of its innovative PD-1 inhibitor serplulimab...
Henlius' 4th Biologics: Bevacizumab Biosimilar Hanbeitai Approved by National Medical Products Administration prnasia
December 06, 2021
Shanghai Henlius Biotech, Inc. (2696.HK) announced that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA).
Henlius Novel Anti PD-L1/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia prnasia
November 26, 2021
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the filing of a clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients with locally advanced...
The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review prnasia
April 23, 2021
Shanghai Henlius Biotech, Inc. announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid ...
Henlius Plans to File the NDA of Novel anti-PD-1 mAb HLX10 for the Treatment of MSI-H Solid Tumours, the Phase 2 Clinical Trial has Met the Primary Endpoint prnasia
March 29, 2021
Shanghai Henlius Biotech, Inc. announced that the Phase 2 study of its innovative PD-1 inhibitor HLX10 in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that fail to ...
Henlius Adalimumab Biosimilar Approved by NMPA prnasia
December 09, 2020
Shanghai Henlius Biotech, Inc. announced that the adalimumab biosimilar HLX03, developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis ...