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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, China, September 16th, 2021 - 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.”

Reference Notes:

[1] Sung H,Ferlay J,Siegel RL,Laversanne M,Soerjomataram I,Jemal A,Bray F.Global cancer statistics 2020:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin.2021 Feb 4.
[2] Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021;134(7):783-791