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
SHANGHAI, Dec. 8, 2021 /PRNewswire/ -- 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 in combination with chemot...
Henlius' 4th Biologics: Bevacizumab Biosimilar Hanbeitai Approved by National Medical Products Administration
SHANGHAI, Dec. 4, 2021 /PRNewswire/ -- 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). It is indicated for the treatment of meta...
Henlius Novel Anti PD-L1/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia
SHANGHAI, Nov. 25, 2021 /PRNewswire/ -- 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 or metastatic solid tumours has been approved by the ...
2021 CSCO | Henlius will Release Four Oral Presentations of Two Upcoming Commercial Products: Novel anti-PD-1 mAb Serplulimab and Bevacizumab Biosimilar
SHANGHAI, Sept. 18, 2021 /PRNewswire/ -- The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) will be held online and in-person from 25th to 29th September 2021. In this meeting, Henlius will release 4 study results of 2 products to be commercialized, the novel anti-PD-1 mAb ser...
The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for First-Line Treatment of sqNSCLC Accepted by China's NMPA, Phase 3 MRCT Met its Primary Endpoint
SHANGHAI, Sept. 17, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of Serplulimab Injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with carboplatin and albumin-bound ...
Henlius reports half-year (H1) 2021 results, outlines remarkable growth in commercialization and needs-driven innovation
SHANGHAI, Aug. 18, 2021 /PRNewswire/ -- Henlius (2696.HK) announced Half-Year (H1) results endedJune 30th, 2021, sharing the company's recent noteworthy progress and achievements. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innov...
The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review
SHANGHAI, April 23, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) 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) s...
The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review
SHANGHAI, April 22, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) 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) s...
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
SHANGHAI, March 29, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) 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 t...
Making Most out of Launched Products Fueling Diversified Innovation through Integrated Platform
SHANGHAI, March 28, 2021 /PRNewswire/ -- Henlius (2696.HK) announced the financial results for the year ended31 December 2020. 2020 marked a meaningful year for Henlius as the Company gathered the pace in commercialization and continued the momentum for innovation. The Company delivered a total r...
Henlius Adalimumab Biosimilar Approved by NMPA
SHANGHAI, Dec. 8, 2020 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) 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 arthrit...
China's First Trastuzumab Biosimilar Approved by NMPA
SHANGHAI, Aug. 17, 2020 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced onAugust 14 that the trastuzumab biosimilar HLX02, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). On 27th July, HLX02 (EU bran...
Henlius and Accord Healthcare Receive EMA Approval for Zercepac®, trastuzumab biosimilar
SHANGHAI, July 30, 2020 /PRNewswire/ -- The European Commission (EC) has approved Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord)'s Zercepac®, a biosimilar trastuzumab, for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive meta...
Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab)
SHANGHAI, June 1, 2020 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing aut...
Henlius receives EU GMP Certificate for HLX02 (Trastuzumab for Injection)
SHANGHAI, April 23, 2020 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's drug substance (DS) line and drug product (DP) line for HLX02 trastuzumab biosimilar have successfully passed the European United (EU) Good Manufacturing Practice (GMP) on-site inspectio...
Henlius successfully held its fourth Scientific Advisory Board (SAB) meeting
SHANGHAI, Feb. 18, 2020 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK, Henlius), a global biologics company specialized in the discovery and development of high-quality and affordable antibodies for the treatment of patients with cancer and autoimmune diseases, recently held its fourth ...
Henlius HLX01 (Rituximab Injection) Wins "Biosimilar Initiative of the Year" at Global Generics & Biosimilars Awards 2019
SHANGHAI, Nov. 7, 2019 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), a leading biopharmaceutical company inChina focusing on oncology and autoimmune diseases, won the award of "Biosimilar Initiative of the Year" (HLX01, rituximab injection) and was also shortlisted for the award of "t...
