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Corporation
HEALTHCARE | Drug Development
henlius.com

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Founded Year

2009

Stage

IPO | IPO

Total Raised

$381M

Date of IPO

9/18/2019

About Shanghai Henlius

Shanghai Henlius (02696.HK) is a joint venture company formed by Shanghai Fosun Pharmaceutical and Henlius Biopharmaceuticals in December 2009. The company focuses on the development, production, and commercialization of mAb biosimilar drugs, bio-betters and mAbs. Products currently in development cover a variety of therapeutic areas including oncology and autoimmune diseases.

Shanghai Henlius Headquarter Location

Building B 1289 Yishan Road Xuhui District

Shanghai, Shanghai,

China

+86 02133395800

Latest Shanghai Henlius News

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

Sep 17, 2021

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. Author: Sep 17, 2021 8:00 AM EDT 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 paclitaxel for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) has been accepted by China's National Medical Products Administration (NMPA). The NDA is based on the results from a randomised, double-blind, global multi-centre Phase 3 clinical trial in patients with locally advanced or metastatic squamous non-small cell lung cancer patients to compare Serplulimab Injection in combination with chemotherapy versus chemotherapy in respect of efficacy and safety. The study results demonstrated that Serplulimab can significantly extend the progression-free survival (PFS) of patients with good safety. In April 2021, the NMPA accepted and officially granted priority review for the NDA of Serplulimab Injection for the treatment of unresectable or metastatic microsatellite instability-high solid tumours that fail to respond to the standard therapy. Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University Medical School, said, "This is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrated that the predefined primary study endpoint had been reached, providing evidence of safety and efficacy. This milestone takes us one step closer to bringing a much-needed treatment option to patients living with sqNSCLC. We are hoping that approval of Serplulimab comes soon." "Serplulimab Injection is an innovative anti-PD-1 mAb independently developed by Henlius, and sqNSCLC is its second listed indication after MSI-H," said Mr. Jason Zhu, Chief Medical Officer and Senior Vice President of Henlius. "Underpinned by the patient-centric strategy, we focus on addressing the clinical needs of high-incidence cancers worldwide and in China. We remain committed to implementing our 'Combo+Global' differentiation strategy with Serplulimab as the backbone, promoting immuno-oncology combination therapies and MRCT, speeding up the development of products in lung cancer and gastrointestinal cancer, and bringing a more hopeful future to patients worldwide." View original content: https://www.prnewswire.com/news-releases/the-nda-of-henlius-novel-anti-pd-1-mab-serplulimab-for-first-line-treatment-of-sqnsclc-accepted-by-chinas-nmpa-phase-3-mrct-met-its-primary-endpoint-301379340.html

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Research containing Shanghai Henlius

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CB Insights Intelligence Analysts have mentioned Shanghai Henlius in 1 CB Insights research brief, most recently on Jun 24, 2021.

Expert Collections containing Shanghai Henlius

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Shanghai Henlius is included in 3 Expert Collections, including Pharma Startups.

P

Pharma Startups

6,549 items

Pharmaceutical companies working across drug discovery, drug development and drug manufacturing.

C

Cancer Therapeutics

1,179 items

Pharmaceutical and biotechnology companies with cancer therapy drug candidates.

C

Cancer

3,592 items

Companies researching, developing, or offering products & services that aid in the screening, prevention, diagnosis, management, and treatment of cancer.

Shanghai Henlius Patents

Shanghai Henlius has filed 3 patents.

The 3 most popular patent topics include:

  • Clusters of differentiation
  • Immune system
  • Molecular biology
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Application Date

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3/13/2019

6/8/2021

Clusters of differentiation, Monoclonal antibodies, Immunology, Immune system, Experimental cancer drugs

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Related Topics

Clusters of differentiation, Monoclonal antibodies, Immunology, Immune system, Experimental cancer drugs

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